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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0007">Introduction</span><p id="para0005" class="elsevierStylePara elsevierViewall">Inborn Error of Immunity &#40;IEI&#41; also referred to as primary immunodeficiency encompass more than 400 heterogeneous genetic diseases with various degrees of impairment of innate or adaptive immune systems&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a> IEI usually manifests early in life with life-threatening or recurrent infections&#44; susceptibility to autoimmunity&#44; malignancy&#44; and autoinflammatory diseases&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a> Predominantly antibody deficiency &#40;PAD&#41; represents more than 50&#37; of IEI<a class="elsevierStyleCrossRefs" href="#bib0001"><span class="elsevierStyleSup">1&#8211;3</span></a> and includes hypogammaglobulinemias&#44; such as X-linked agammaglobulinemia &#40;XLA&#41;&#44; transitory hypogammaglobulinemia of infancy &#40;THI&#41;&#44; and common variable immunodeficiency &#40;CVID&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a> but also functional antibody defects&#44; as specific antibody deficiency &#40;SAD&#41;&#44; which is characterized by an abnormal IgG antibody response to a pneumococcal vaccine with normal IgG&#44; in patients older than two years of age&#46;<a class="elsevierStyleCrossRefs" href="#bib0002"><span class="elsevierStyleSup">2&#8211;4</span></a> Other more genetically complex IEI&#44; including combined immunodeficiencies&#44; diseases of immune dysregulation&#44; and combined immunodeficiencies with syndromic features&#44; however also present with defects in the humoral system that contribute to an increased susceptibility to infections&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a></p><p id="para0006" class="elsevierStylePara elsevierViewall">Patients with PAD have frequent hospitalizations and immunoglobulin replacement therapy &#40;IgRT&#41;&#44; via intravenous &#40;IVIG&#41; or subcutaneous &#40;IGSC&#41;&#44; is currently the leading therapeutic approach&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">5&#8211;7</span></a> The usual loading dose of IVIG is 400 to 600&#160;mg&#47;kg&#47;dose every 3&#8211;4 weeks&#44; but higher doses between 600 and 800&#160;mg&#47;kg&#47;dose &#40;or up to 1200&#160;mg&#47;kg&#41; may be required and are particularly indicated in case of chronic lung and&#47;or sinus diseases&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">5&#8211;7</span></a></p><p id="para0007" class="elsevierStylePara elsevierViewall">Many studies have reported the benefits of human Ig in reducing episodes of bacterial infections&#44; hospital admission&#44; as well as prevention of chronic pulmonary disease and survival in patients with IEI&#46;<a class="elsevierStyleCrossRefs" href="#bib0006"><span class="elsevierStyleSup">6&#8211;10</span></a> In Brazil IVIG is provided by the government for patients with IEI<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> and&#44; as far as we know&#44; there is no data focusing on the efficacy of IVIG in reducing hospital admission in pediatric Brazilian patients with IEI&#46; The goal of this study was to assess hospital admission&#44; as well as the length of stay &#40;LOS&#41; in children with IEI&#44; pre and one-year post-intravenous immunoglobulin therapy initiation &#40;IVIG&#41; in a tertiary pediatric hospital&#46; Major causes of hospital admission were also evaluated&#46;</p></span><span id="sec0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0008">Methods</span><p id="para0008" class="elsevierStylePara elsevierViewall">A retrospective study was carried out enrolling children with IEI under regular IVIG therapy for at least one year&#44; over the period comprised between 2011 and 2019 in a pediatric tertiary hospital in Brazil&#46; Data were collected from July-2018 to July-2019&#44; by reviewing medical records and interviewing the patient&#39;s family members&#46; The inclusion criteria were &#40;i&#41; age from 1 month of age to 18 years old during the therapy&#59; &#40;ii&#41; diagnosis of IEI based on the diagnostic criteria of the American<a class="elsevierStyleCrossRef" href="#bib0003"><span class="elsevierStyleSup">3</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a> and European Societies for Immunodeficiency<a class="elsevierStyleCrossRef" href="#bib0011"><span class="elsevierStyleSup">11</span></a>&#59; &#40;iii&#41; baseline laboratory tests showing a decrease in serum IgG &#40;at least two standard deviations below the reference mean for age&#41;<a class="elsevierStyleCrossRef" href="#bib0012"><span class="elsevierStyleSup">12</span></a> in minimum two tests and&#47;or impaired vaccine response &#40;rubella&#44; measles&#44; hepatitis B and purified polysaccharide vaccine &#40;23-PPV&#41;<a class="elsevierStyleCrossRef" href="#bib0013"><span class="elsevierStyleSup">13</span></a>&#59; &#40;iv&#41; regular IVIG replacement therapy for at least 12 months&#46; Clinical data collected were&#58; age at onset symptoms&#44; age at diagnosis&#44; IVIG period&#44; lymphocyte counts and immunoglobulin &#40;Ig&#41; serum level pre and post-IVIG &#40;12-months after IVIG initiation&#41;&#44; age at IVIG initiation&#44; diagnostic delay&#44; number of hospital admission&#44; length of stay at hospital and type of infection&#58; a&#41; pneumonia&#59; b&#41; upper respiratory infections &#40;pharyngitis&#44; tonsillitis&#44; sinusitis&#44; and otitis media&#41;&#44; c&#41; others &#40;including gastrointestinal diseases and urinary tract infection&#41;&#46; Pre-IVIG was defined as the period between the first infection and IVIG initiation&#44; and post-IVIG assessment took place 12 months after initiation of IgG therapy&#46; Patients with low IgG in the baseline were allocated into the hypogammaglobulinemia group&#44; their clinical and laboratory data pre and post-IVIG therapy was analyzed independently on the others&#46; Data on antibiotics and immunosuppressive drugs used in association with IVIG during the first year of IVIG were also studied&#46; Diagnosis of SAD was done in children older than 24 months of age with impaired IgG production to the purified polysaccharide vaccine &#40;23-PPV&#41; antigens in the presence of normal immunoglobulin concentrations and normal antibody responses to protein&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0013"><span class="elsevierStyleSup">13</span></a> Patients were tested for a minimum of seven serotypes and 1&#46;3&#160;&#956;g&#47;mL was considered protective IgG concentration for each serotype&#44; according to the literature&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a> Normal antibody response to polysaccharide antigens is defined differently according to age&#58; in children aged 2&#8211;5 years&#44; &#62;50&#37; of concentrations tested are considered protective&#44; with an increase of at least 2- fold observed&#44; and in patients aged 6&#8211;65 years&#44; &#62;70&#37; of concentrations tested are considered protective&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a> Length of stay &#40;LOS&#41; was defined as the duration of hospital stay from the day of hospital admission until the patient&#180;s discharge&#46; Patients were excluded if the follow-up was less than 12 months or noncompliance&#46; The study was approved by the Institutional Research Ethics Committee&#46;</p></span><span id="sec0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0009">Statistical analysis</span><p id="para0009" class="elsevierStylePara elsevierViewall">Data are described as frequency&#44; median&#44; mean&#44; range&#44; and interquartile range &#40;IQR&#41;&#46; Analysis was performed with Graph Pad Prism v&#46;6&#46;05&#174; &#40;GraphPad Software&#44; La Jolla&#44; USA&#41; and IBM SPSS &#40;<span class="elsevierStyleItalic">Statistical</span>&#160;Package&#160;<span class="elsevierStyleItalic">for the</span>&#160;Social&#160;<span class="elsevierStyleItalic">Sciences</span>&#41; &#174; 23&#44; 2015&#46; Kolmogorov-Smirnov&#180;s test was used as a normality test and the Wilcoxon test was used for quantitative and related samples&#46; Mc Nemar test and <span class="elsevierStyleItalic">U</span> Mann&#8211;Whitney tests were used to compare qualitative and quantitative non-parametrical data&#44; respectively&#46; Statistical significance when <span class="elsevierStyleItalic">p</span> value &#60; 0&#46;05&#46;</p></span><span id="sec0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0010">Results</span><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0011">Clinical features of all studied patients</span><p id="para0010" class="elsevierStylePara elsevierViewall">In total 45 children with IEI under IVIG therapy were studied&#44; and most of them were male &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;29&#47;64&#46;4&#37;&#41;&#46; The median age at onset of symptoms was six months old and at IVIG initiation was 74mo&#46; Baseline characteristics and Ig levels pre and post-IVIG of all patients are summarized in <a class="elsevierStyleCrossRef" href="#tbl0001">Table 1</a>&#46; Most of the patients &#40;80&#37;&#41; had hypogammaglobulinemia or functional antibody defect &#40;<a class="elsevierStyleCrossRef" href="#tbl0002">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0001"></elsevierMultimedia><elsevierMultimedia ident="tbl0002"></elsevierMultimedia></span><span id="sec0006" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0012">Hypogammaglobulinemic patients</span><p id="para0011" class="elsevierStylePara elsevierViewall">Twenty-two patients were classified in the group hypogammaglobulinemia&#44; most of them were males &#40;81&#46;8&#37;&#41;&#44; and median age of 10 months &#40;3&#8211;180 months&#41; &#40;Supplementary Table 1&#41;&#46; In this group were included patients with CVID &#40;5&#47;22&#41;&#44; XLA &#40;3&#47;22&#41;&#44; and THI &#40;6&#47;22&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0002">Table 2</a>&#41;&#46; The authors also included patients with <span class="elsevierStyleItalic">other hypogammaglobulinemias &#40;OH&#41;</span> &#40;8&#47;22<span class="elsevierStyleItalic">&#41;</span>&#44; which means patients without a well-defined diagnosis&#44; who had a history of recurrent infections and low IgG and&#47;or IgM or IgA&#44; some of these patients had neutropenia &#40;4&#47;21&#41;&#44; others had lymphopenia &#40;3&#47;7&#41;&#46;</p><p id="para0012" class="elsevierStylePara elsevierViewall">The patient with the highest LOS pre-IVIG &#40;167 days&#47;year&#41; was admitted at the age of 2&#46;7 years old&#44; after several hospital admissions&#44; complicated by neurologic sequelae &#40;Supplementary Table 1&#41;&#46; He had pre-IgG levels of 212&#160;mg&#47;dL with normal IgA and IgM&#46; IVIG therapy was initiated in a loading dose of 508&#160;mg&#47;kg&#47;monthly associated with antibiotic prophylaxis&#44; and after 12-months-IVIG&#44; he spent 24 days at the hospital and his IgG levels increased to 984&#160;mg&#47;dL&#46;</p><p id="para0013" class="elsevierStylePara elsevierViewall">The lowest IgG level post -IVIG &#40;478&#160;mg&#47;dL&#41; was observed in a 14-year-old-girl who had CVID phenotype and autoimmune anemia &#40;AIA&#41;&#44; this patient also had the lowest CD4&#43; T cell counts pre and post IVIG&#44; 280&#160;cells&#47;&#181;L and 240&#160;cells&#47;&#181;L&#44; respectively&#46; Perhaps the concomitant use of corticosteroids to treat AIA has influenced her laboratory results&#44; on the other way&#44; she did not require hospital admission in that year&#46;</p><p id="para0014" class="elsevierStylePara elsevierViewall">More than half of hypogammaglobulinemic patients &#40;12&#47;54&#46;5&#37;&#41;&#44; had nearly critical values of IgG serum levels &#40;200&#160;mg&#47;dL&#41; when they were admitted&#46; As the study&#39;s data are retrospective&#44; some patients are not under IVIG therapy anymore&#44; e&#46;g&#46; patients with THI&#46;</p></span><span id="sec0007" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0013">Patients with specific antibody deficiency and complex IEI</span><p id="para0015" class="elsevierStylePara elsevierViewall">In total 14 patients received a diagnosis of SAD&#46; All patients had severe infection leading to hospital admission&#44; and in 10 patients&#44; a chest computed &#40;CT&#41; scan was available&#44; five patients &#40;35&#46;7&#37;&#41; of SAD patients showed some lung abnormality such as atelectasis&#44; bronchiectasis and ground-glass opacity&#46;</p><p id="para0016" class="elsevierStylePara elsevierViewall">Nine patients with well-defined IEI&#44; such as Ataxia-telangiectasia and Chronic Granulomatous Disease with hypogammaglobulinemia &#40;one case each&#41; and Hyper IgE syndrome&#44; &#40;4 cases&#41; were included in this study &#40;<a class="elsevierStyleCrossRef" href="#tbl0002">Table 2</a>&#41;&#46; Purine nucleoside phosphatase &#40;PNP&#41; deficiency and X-linked lymphoproliferative syndrome &#40;XLP&#41; were also diagnosed in two boys&#44; who underwent hematopoietic cell transplantation afterwards&#46;</p><p id="para0017" class="elsevierStylePara elsevierViewall">IVIG dose ranged from 400 to 800&#160;mg&#47;kg &#40;median 517&#160;mg&#47;kg&#41; every three to four weeks&#44; based on the clinical feature and the updated guidelines<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0014"><span class="elsevierStyleSup">14</span></a> &#40;Supplementary Table 2&#41;&#46; The highest loading dose was observed in a patient with Hyper IgM syndrome with several pulmonary sequelae&#44; including bronchiectasis and bronchiolitis obliterans with organizing pneumonia &#40;BOOP&#41;&#44; who was diagnosed at the age of 11yo11months&#44; and onset symptoms at 3yo&#46;</p></span><span id="sec0008" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0014">Number of hospitalization and length of stay &#40;LOS&#41; after IVIG therapy</span><p id="para0018" class="elsevierStylePara elsevierViewall">Almost all patients &#40;44&#47;97&#46;8&#37;&#41; had documented hospital admission prior to IVIG and only 10 patients &#40;24&#37;&#41; post-IVIG&#46; The annual number of hospital admission decreased significantly from 2&#46;5 &#40;median&#58;1&#46;2&#44; range&#58; 0&#8211;30&#41; to 0&#46;5 &#40;median&#58; 0&#44; range&#58;0&#8211;5&#41;&#46; The LOS reduced from 71 days &#40;range&#58; 0&#8211;304&#41; to 4&#46;7 &#40;median&#58; 54&#44; range&#58; 1&#8211;55&#41; per patient &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; <a class="elsevierStyleCrossRef" href="#fig0001">Fig&#46;&#160;1</a>A e 1B&#46; The number of children who required PICU was also significantly reduced from 17 &#40;37&#46;7&#37;&#41; with a mean of LOS of 17&#46;2 days&#47;year &#40;range&#58;1&#8211;150&#41; to zero &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0002&#41; <a class="elsevierStyleCrossRef" href="#fig0001">Fig&#46;&#160;1</a>C&#46;</p><elsevierMultimedia ident="fig0001"></elsevierMultimedia><p id="para0019" class="elsevierStylePara elsevierViewall">One male patient had 30 hospital admissions pre-IVIG&#44; his first immunologic visit was at nine years of age&#44; with a history of recurrent infections since two&#46; He had low IgG&#44; impaired vaccine response&#44; and low CD4&#43; T cells and B cells&#46; After IgRT he had just one hospital admission&#46;</p></span><span id="sec0009" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0015">Reduction in respiratory infection episodes after IVIG</span><p id="para0020" class="elsevierStylePara elsevierViewall">The authors observed a significant reduction in the number of patients hospitalized due to pneumonia&#44; the main cause of hospital admission&#44; from 84&#46;4&#37; to 5&#37;&#46; The number of episodes per patient decreased from an average of 2&#46;2 &#40;median&#58;1&#44; range&#58;0&#8211;14&#41; to 0&#46;1 per year &#40;median&#58;0&#44; range&#58; 0&#8211;2&#41; &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0002">Fig&#46;&#160;2</a>A&#41;&#46; Upper respiratory tract infections &#40;URTI&#41; episodes also reduced&#44; from a mean of 1&#46;1 to 0&#46;1 episode annually&#44; pre and post-IVIG&#44; respectively &#40;<span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0002">Fig&#46;&#160;2</a>B&#41;&#46; Other causes of hospital admission&#44; such as gastroenteritis&#44; urinary infections&#44; surgery were also noted&#44; but in less frequency and not described&#46;</p><elsevierMultimedia ident="fig0002"></elsevierMultimedia></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0016">Concomitant use of antibiotics or immunosuppressive drugs could have influenced the reduction in hospital admissions&#63;</span><p id="para0021" class="elsevierStylePara elsevierViewall">Eleven patients &#40;24&#46;4&#37;&#41; received prophylaxis with antibiotics &#40;azithromycin&#44; amoxicillin and cotrimoxazol&#41; and&#47;or antifungals &#40;itraconazole&#41; during the study period&#46; The authors also noted that four patients &#40;8&#46;9&#37;&#41; received immunosuppressive drugs&#44; such as corticosteroids&#44; cyclosporine and azathioprine&#46; Pulmonary sequelae&#44; autoimmune cytopenia as well as conventional management of some IEI&#44; as HIES and CGD were the reason to prescribe these medications &#40;Supplementary Table 3&#41;&#46;</p><p id="para0022" class="elsevierStylePara elsevierViewall">None data on drugs used previously with IVIG therapy were collected&#46; However&#44; in order to see whether the concomitant use of antibiotics or immunosuppressive drugs associated with IVIG therapy&#44; could have influenced the present study&#39;s results&#44; a comparative analysis was performed&#46; Neither number of hospital admission nor hospital stay was influenced by antibiotics use or immunosuppressive drugs &#40;Supplementary Table 3&#41;<span class="elsevierStyleBold">&#46;</span> Data on the number and type of infections and laboratory results were also studied and&#44; higher IgG and IgM levels post-IVIG in patients taking antibiotics were observed compared to patients without this medication&#44; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;02 and <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;03&#44; respectively&#46;</p></span></span><span id="sec0011" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0017">Discussion</span><p id="para0023" class="elsevierStylePara elsevierViewall">The benefit of human Ig in patients with primary antibody deficiency and in diseases with immune dysregulation related to a genetically defined IEI&#44; is unquestionable and has been well described in other countries&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRefs" href="#bib0008"><span class="elsevierStyleSup">8&#8211;10</span></a> The main purpose of this study was to describe the efficacy of IVIG in reducing the number of hospital admission&#44; LOS&#44; and the number of pneumonia cases in the first year of IVIG replacement therapy and&#44; as far as we know&#44; it is the first study evidencing the impact of Ig therapy in a pediatric cohort with IEI in Brazil&#46;</p><p id="para0024" class="elsevierStylePara elsevierViewall">Forty-five children were studied with a predominance of males&#44; as observed by others and not well understood&#46;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">15</span></a> All patients had recurrent infections&#44; mainly pneumonia&#44; early in life &#40;median 6 months of age&#41;&#46; However&#44; the median duration of diagnostic delay was 63 months&#44; almost the half median age of studied patients &#40;133 months&#41;&#46; It is late considering the advances in techniques to diagnosis IEI in the last decades and also higher than data from Peru and Mexico&#46;<a class="elsevierStyleCrossRef" href="#bib0016"><span class="elsevierStyleSup">16</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0017"><span class="elsevierStyleSup">17</span></a> Previous studies have shown that the earlier the diagnosis of IEI and establishment of suitable treatment&#44; the less is the number and severity of infectious complications and hospital admission&#46;<a class="elsevierStyleCrossRef" href="#bib0009"><span class="elsevierStyleSup">9</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0017"><span class="elsevierStyleSup">17</span></a> The present study&#39;s data suggest a difficulty for general physicians and pediatricians to conceive IEI diagnosis in children with recurrent pneumonia&#44; as well as low awareness of management of IEI&#44; as observed previously in Brazil&#46;<a class="elsevierStyleCrossRef" href="#bib0018"><span class="elsevierStyleSup">18</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0019"><span class="elsevierStyleSup">19</span></a></p><p id="para0025" class="elsevierStylePara elsevierViewall">Human Ig preparations are derived from a plasma pool and contain 95&#8211;99&#37; protective titers of IgG against a large number of pathogens with traces of IgM and IgA&#44; depending on the purification and fractionation process&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0014"><span class="elsevierStyleSup">14</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">20</span></a> Higher IgG serum levels after Ig therapy is expected and correlated with low frequency of infections and hospital admission&#44;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0021"><span class="elsevierStyleSup">21</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0022"><span class="elsevierStyleSup">22</span></a> as the authors observed in patients into the group hypogammaglobulinemia&#46; The authors also noticed a significant reduction in the annual LOS&#44; probably influencing other clinical and social aspects&#44; i&#46;e&#46; use of intravenous antibiotics&#44; growth&#44; and number of absent school days as mentioned by others&#46;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0023"><span class="elsevierStyleSup">23</span></a></p><p id="para0026" class="elsevierStylePara elsevierViewall">Replacement therapy for some groups of IEI is crucial and life-saving&#44; such as XLA&#44; CVID&#44; and severe combined immunodeficiency &#40;SCID&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a> Other genetically complex IEI&#44; such as Wiskott-Aldrich syndrome&#44; Ataxia-telangiectasia&#44; XLP&#44; Hyper E and IgM syndromes&#44; also have defects in antibody production or function that contribute to an increased susceptibility to infections and the benefits of IgRT has been described&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a></p><p id="para0027" class="elsevierStylePara elsevierViewall">Consensus recommendations for the use of human Ig replacement are&#58; serum IgG &#60; 200&#160;mg&#47;dL&#44; which is always an indication&#44; except for patients with transient hypogammaglobulinemia of infancy with no severe infections&#59; serum IgG between 200 and 500&#160;mg&#47;dL is an indication in case of antibody production deficiency or recurrent and&#47;or severe infections&#59; serum IgG &#62; 500&#160;mg&#47;dL is an indication for Ig replacement only when abnormal production of specific antibodies is verified&#44; and recurrent and severe infections are present&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0014"><span class="elsevierStyleSup">14</span></a></p><p id="para0028" class="elsevierStylePara elsevierViewall">In young children&#44; especially infants&#44; with low antibody production&#44; the definitive diagnosis can be very difficult&#46; It can result from an immaturity of the immune system or transient impaired production&#46;<a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0011"><span class="elsevierStyleSup">11</span></a> Nevertheless&#44; patients with IgG levels below 200&#160;mg&#47;dL with a previous history of severe infections requiring hospital admission&#44; are a candidate for Ig replacement due to the high risk of complications&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> According to Schartoj&#233; and colleagues&#44; it is impossible to predict which child will recover and which one will suffer from a more or less severe disease in the future&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">15</span></a> Recently Janssen and others&#44; evaluating patients &#40;adults and children&#41; with unclassified hypogammaglobulinemia &#40;unPAD&#41;&#44; alert that these patients can have comorbidities similar to other well-defined IEI&#44; influencing their quality of life&#46;<a class="elsevierStyleCrossRef" href="#bib0024"><span class="elsevierStyleSup">24</span></a></p><p id="para0029" class="elsevierStylePara elsevierViewall">Diagnosis of SAD is also not so easy to establish&#44; it involves a careful clinical and laboratory evaluation&#46; In Brazil it has been a challenge to perform this diagnosis in the public health system&#46; According to Costa-Carvalho et al&#46; in a survey involving 17 Brazilian public reference centers of Immunology&#44; fewer than 10&#37; of clinical immunologists were able to evaluate the response to the pneumococcus polysaccharide vaccine&#46; In the present study&#44; the diagnosis was done evaluating a minimum of seven serotypes&#46; Perhaps the authors have lost some diagnosis during the eight-year period&#44; but patients with diagnosis SAD described in this study had documented recurrent or severe respiratory infections and poor response to pneumococcal polysaccharide vaccination&#59; besides&#44; most of them had pulmonary sequelae on chest CT scan&#46;</p><p id="para0030" class="elsevierStylePara elsevierViewall">It&#180;s important to keep in mind that Ig therapy is not recommended in all patients with SAD&#46; The therapeutic strategies depend on the clinical manifestation and include an additional dose with conjugated pneumococcal&#44; antibiotic prophylaxis&#44; and Ig replacement therapy&#46; Among them&#44; antibiotic prophylaxis has been described as the mainstay of therapy for patients with SAD&#46;<a class="elsevierStyleCrossRef" href="#bib0013"><span class="elsevierStyleSup">13</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">25</span></a></p><p id="para0031" class="elsevierStylePara elsevierViewall">Perez et&#160;al&#46; described some features to consider Ig therapy in patients with SAD&#44; including&#58; i&#46; severe or very frequent recurrent infections&#59; ii&#46; inability to tolerate antibiotic prophylaxis due to multiple hypersensitivities&#44; severe side effects or complications such as Clostridium difficile colitis&#44; etc&#46;&#59; or iii&#46; failure to respond to prophylactic antibiotics <span class="elsevierStyleSup">25</span>&#46; In this study&#44; the authors also took into account abnormalities on chest CT scan as recommended in the Brazilian consensus on IgRT&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a></p><p id="para0032" class="elsevierStylePara elsevierViewall">Prior to IVIG 17 children &#40;37&#46;8&#37;&#41; required intensive care&#44; suggesting a poor clinical status associated infections with a high risk to develop sequela&#44; especially chronic pulmonary disease&#46; The efficacy of IVIG in reducing the number as well the severity of infections was remarkable and it may have had a positive impact on the economic burden to the Brazilian health care system&#44; taking into account the high daily cost of an intensive care unit day and&#44; also that none patient was admitted in the PICU in the first 12 months of Ig therapy&#46; Further studies on these results and economic impacts would be required&#46;</p><p id="para0033" class="elsevierStylePara elsevierViewall">Most of the patients &#40;84&#46;4&#37;&#41; had experienced at least 1 episode of pneumonia leading to hospital admission prior to IVIG&#46; The occurrence of bacterial respiratory infections is the main clinical presentation of IEI&#44; and many patients experience multiple episodes before the diagnosis&#46;<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0018"><span class="elsevierStyleSup">18</span></a> Orange and colleagues described that the prevalence of pneumonia and the pneumonia risk was inversely correlated with high IgG levels &#40;up to at least 1000&#160;mg&#47;dL&#41; in patients with hypogammaglobulinemia&#46;<a class="elsevierStyleCrossRef" href="#bib0022"><span class="elsevierStyleSup">22</span></a> On the other hand&#44; Quinti et al&#46;&#44; correlated the high number of pneumonia with low IgA levels pre and post- IVIG in CVID patients&#46;<a class="elsevierStyleCrossRef" href="#bib0021"><span class="elsevierStyleSup">21</span></a> In this study&#44; no difference was noted between IgA levels pre and post-treatment&#44; and as the study cohort included complex IEI and SAD patients&#44; the significant reduction in pneumonia episodes after IVIG treatment suggest that not only IgG levels per se&#44; but also IgG function were balanced in the first year of Ig therapy&#46;</p><p id="para0034" class="elsevierStylePara elsevierViewall">This study has some limitations&#44; as the heterogeneity of IEI diseases&#44; absent detailed data about chronic lung disease&#44; and infections others than the respiratory tract&#46; However&#44; the authors highlight for the first time the efficacy of IVIG replacement therapy in Brazilian children with IEI&#44; in reducing hospital admission&#44; LOS&#44; and number of pneumonia&#46; The authors expect that the present study data can help physicians&#44; especially pediatricians&#44; to be alert of a possible diagnosis of IEI in cases of recurrent or severe pneumonia leading to hospital admission&#44; and to consider IgRT if necessary&#46;</p></span><span id="sec0012" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0018">Funding</span><p id="para0035" class="elsevierStylePara elsevierViewall">LMA&#44; Scholarship &#40;August&#46;2018 to July&#46;2019&#41; has been provided by Instituto do C&#226;ncer Infantil e Pediatria Especializada&#47; Hospital da Crian&#231;a de Bras&#237;lia Jos&#233; Alencar&#46;</p></span></span>"
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          "titulo" => "Abstract"
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              "identificador" => "abss0001"
              "titulo" => "Objectives"
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              "titulo" => "Methods"
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              "titulo" => "Results"
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              "titulo" => "Conclusion"
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          "titulo" => "Keywords"
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          "titulo" => "Introduction"
        ]
        3 => array:2 [
          "identificador" => "sec0002"
          "titulo" => "Methods"
        ]
        4 => array:2 [
          "identificador" => "sec0003"
          "titulo" => "Statistical analysis"
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          "titulo" => "Results"
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              "identificador" => "sec0005"
              "titulo" => "Clinical features of all studied patients"
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              "titulo" => "Hypogammaglobulinemic patients"
            ]
            2 => array:2 [
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              "titulo" => "Patients with specific antibody deficiency and complex IEI"
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              "titulo" => "Number of hospitalization and length of stay &#40;LOS&#41; after IVIG therapy"
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              "titulo" => "Reduction in respiratory infection episodes after IVIG"
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              "titulo" => "Concomitant use of antibiotics or immunosuppressive drugs could have influenced the reduction in hospital admissions&#63;"
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          "titulo" => "Discussion"
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        7 => array:2 [
          "identificador" => "sec0012"
          "titulo" => "Funding"
        ]
        8 => array:2 [
          "identificador" => "xack593216"
          "titulo" => "Acknowledgments"
        ]
        9 => array:1 [
          "titulo" => "References"
        ]
      ]
    ]
    "pdfFichero" => "main.pdf"
    "tienePdf" => true
    "fechaRecibido" => "2021-03-17"
    "fechaAceptado" => "2021-05-14"
    "PalabrasClave" => array:1 [
      "en" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec1493467"
          "palabras" => array:4 [
            0 => "Primary immunodeficiency"
            1 => "Inborn Errors of Immunity"
            2 => "Human immunoglobulin"
            3 => "Therapy"
          ]
        ]
      ]
    ]
    "tieneResumen" => true
    "resumen" => array:1 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abss0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0002">Objectives</span><p id="spara006" class="elsevierStyleSimplePara elsevierViewall">To compare the frequency of hospitalization in children with Inborn Errors of Immunity with antibody deficiency previous to intravenous immunoglobulin &#40;pre- IVIG&#41; with a one-year period after initial IVIG &#40;post-IVIG&#41;&#46;</p></span> <span id="abss0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0003">Methods</span><p id="spara007" class="elsevierStyleSimplePara elsevierViewall">Medical reports of 45 patients during an eight-year period were reviewed from 2018 to 2019&#46; Wilcoxon-test was used for related samples&#46;</p></span> <span id="abss0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Results</span><p id="spara008" class="elsevierStyleSimplePara elsevierViewall">Forty-five children were included in the study&#44; aged 29&#8211;249 months of age&#44; and most of them &#40;64&#46;4&#37;&#41; were males&#46; Median ages at onset symptoms and at diagnosis were 6 and 73 months old&#44; respectively&#46; Specific antibody deficiency and unclassified hypogammaglobulinemia were the predominant diagnoses &#40;31&#46;1&#37; and 17&#46;8&#37;&#44; respectively&#41;&#46; X-linked agammaglobulinemia&#44; Hyper IgE syndrome&#44; Hyper IgM&#44; transient hypogammaglobulinemia of infancy&#44; and Common Variable Immunodeficiency &#40;CVID&#41; were also reported&#44; in a low frequency&#46; Forty-four &#40;97&#46;8&#37;&#41; patients were hospitalized before IVIG&#44; and 10 patients &#40;22&#46;2&#37;&#41; after&#46; Annual mean hospital admission reduced from 2&#46;5 to 0&#46;5&#44; pre and post-IVIG&#44; respectively &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; Mean length of stay &#40;LOS&#41; reduced from 71 to 4&#46;7 days&#47;year &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; in general ward and in the PICU from 17&#46;2 days&#47;year to zero &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0002&#41;&#46; Pneumonia was the main cause of hospital admission with a reduction in the number of episodes per patient from an average of 2&#46;2&#8211;0&#46;1 per year &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;001&#41;&#46; Concomitant use of antibiotic prophylaxis did not influence the number of hospital admission&#46;</p></span> <span id="abss0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0005">Conclusion</span><p id="spara009" class="elsevierStyleSimplePara elsevierViewall">One-year intravenous IVIG significantly decreased the number of hospitalizations and length of stay in children with impaired antibody production&#46; Social and economic impacts would be required&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abss0001"
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            "etiqueta" => "Appendix"
            "titulo" => "Supplementary materials"
            "identificador" => "sec0014"
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      0 => array:8 [
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        "etiqueta" => "Figure 1"
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          "en" => "<p id="spara001" class="elsevierStyleSimplePara elsevierViewall">Comparative analyses of 45 patients previously &#40;Pre&#41; and one-year post-Immunoglobulin therapy initiation &#40;post-IVIG&#41; in pediatric patients with IEI&#46; In total 44 and 10 patients were hospitalized pre and post-IVG respectively&#46; Figure &#40;1A&#41; represents the number of hospital admission&#47;patient&#47;year pre-IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;44 patients&#41; and post-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;10 patients&#41;&#46; Length of stay &#40;LOS&#41;&#47;patient&#47;year in general ward&#44; Pre-IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;44 patients&#41;&#44; post-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;10 patients&#41; &#40;1B&#41;&#46; Figure 1C describes the LOS in Pediatric Intensive Care Unit -PICU per year &#47;patient&#44; Pre-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;17 patients&#41; and post-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;0 patient&#41;&#46; Wilcoxon-test&#46; Statistical significance when <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#46;</p>"
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        "mostrarFloat" => true
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        "figura" => array:1 [
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          "en" => "<p id="spara002" class="elsevierStyleSimplePara elsevierViewall">A&#41; In 45 patients with Inborn Error of Immunity&#44; the number of patients who had pneumonia reduced from 37 to 5&#44; pre and post-IVIG therapy&#44; respectively&#44; and <a class="elsevierStyleCrossRef" href="#fig0002">Fig&#46;&#160;2</a>A illustrates the number of pneumonia episodes per patient per year&#44; pre-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;37 patients&#41; and post-IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;5 patients&#41; and&#59; 2B&#41; Number of upper respiratory tract infection &#40;URTI&#41; episodes per patient per year&#44; pre&#8211;IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;20 patients&#41; and post-IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;5 patients&#41;&#46; Wilcoxon-test&#46; Statistical significance when <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05<span class="elsevierStyleBold">&#46;</span></p>"
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                  \t\t\t\t  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">Median &#40;range&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">29 &#40;64&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">Age at onset symptoms&#44; months&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">6 &#40;1&#8211;60&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0009"></a><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">Age at diagnosis&#44; months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><a name="en0010"></a><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">73 &#40;3&#8211;204&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0011"></a><td class="td-with-role" title="\n
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                  \t\t\t\t</td><a name="en0012"></a><td class="td" title="\n
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                  \t\t\t\t  " align="char" valign="top">63 &#40;0&#46;5&#8211;198&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">Age at IVIG initiation&#44; months&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">74 &#40;5&#8211;215&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0015"></a><td class="td-with-role" title="\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">IVIG period&#44; months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><a name="en0016"></a><td class="td" title="\n
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                  \t\t\t\t  " align="char" valign="top">46 &#40;12&#8211;136&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0017"></a><td class="td-with-role" title="\n
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                  \t\t\t\t</td><a name="en0018"></a><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">545&#46;5 &#40;78&#8211;1870&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0019"></a><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">IgG post- IVIG &#47;mg&#47;dL&#41;<a class="elsevierStyleCrossRef" href="#tb1fn1"><span class="elsevierStyleSup">a</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><a name="en0020"></a><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">941 &#40;478&#8211;2460&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0021"></a><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">IgA pre-IVIG &#40;mg&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><a name="en0022"></a><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">28&#46;8 &#40;1&#8211;414&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">IgA post-IVIG &#40;mg&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="top">77 &#40;0&#8211;509&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">IgM post-IVIG &#40;mg&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
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          "en" => "<p id="spara003" class="elsevierStyleSimplePara elsevierViewall">Clinical and laboratory characteristics of studied patients &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;45&#41;&#46;</p>"
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                  \t\t\t\t  " align="char" valign="top">6 &#40;13&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><a name="en0037"></a><td class="td" title="\n
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                  \t\t\t\t  " align="" valign="top">X-linked agammaglobulinemia &#40;XLA&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="top">3 &#40;6&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
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Original article
One-year intravenous immunoglobulin replacement therapy: efficacy in reducing hospital admissions in pediatric patients with Inborn Errors of Immunity
Karina Mescouto de Meloa,
Corresponding author
karina.melo@hcb.org.br

Corresponding author.
, Lucas Macedo Alvesb, Cláudia França Cavalcante Valentea, Fabíola Scancetti Tavaresa,c
a Hospital da Criança de Brasília José Alencar, Clínica de Alergia e Imunologia, Brasília, DF, Brazil
b Universidade de Brasília (UNB), Faculdade de Medicina, Brasília, DF, Brazil
c Hospital Universitário de Brasília (HUB), Brasília, DF, Brazil
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    "titulo" => "One-year intravenous immunoglobulin replacement therapy&#58; efficacy in reducing hospital admissions in pediatric patients with Inborn Errors of Immunity"
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          "en" => "<p id="spara001" class="elsevierStyleSimplePara elsevierViewall">Comparative analyses of 45 patients previously &#40;Pre&#41; and one-year post-Immunoglobulin therapy initiation &#40;post-IVIG&#41; in pediatric patients with IEI&#46; In total 44 and 10 patients were hospitalized pre and post-IVG respectively&#46; Figure &#40;1A&#41; represents the number of hospital admission&#47;patient&#47;year pre-IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;44 patients&#41; and post-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;10 patients&#41;&#46; Length of stay &#40;LOS&#41;&#47;patient&#47;year in general ward&#44; Pre-IVIG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;44 patients&#41;&#44; post-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;10 patients&#41; &#40;1B&#41;&#46; Figure 1C describes the LOS in Pediatric Intensive Care Unit -PICU per year &#47;patient&#44; Pre-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;17 patients&#41; and post-IVG &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;0 patient&#41;&#46; Wilcoxon-test&#46; Statistical significance when <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0007">Introduction</span><p id="para0005" class="elsevierStylePara elsevierViewall">Inborn Error of Immunity &#40;IEI&#41; also referred to as primary immunodeficiency encompass more than 400 heterogeneous genetic diseases with various degrees of impairment of innate or adaptive immune systems&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a> IEI usually manifests early in life with life-threatening or recurrent infections&#44; susceptibility to autoimmunity&#44; malignancy&#44; and autoinflammatory diseases&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a> Predominantly antibody deficiency &#40;PAD&#41; represents more than 50&#37; of IEI<a class="elsevierStyleCrossRefs" href="#bib0001"><span class="elsevierStyleSup">1&#8211;3</span></a> and includes hypogammaglobulinemias&#44; such as X-linked agammaglobulinemia &#40;XLA&#41;&#44; transitory hypogammaglobulinemia of infancy &#40;THI&#41;&#44; and common variable immunodeficiency &#40;CVID&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a> but also functional antibody defects&#44; as specific antibody deficiency &#40;SAD&#41;&#44; which is characterized by an abnormal IgG antibody response to a pneumococcal vaccine with normal IgG&#44; in patients older than two years of age&#46;<a class="elsevierStyleCrossRefs" href="#bib0002"><span class="elsevierStyleSup">2&#8211;4</span></a> Other more genetically complex IEI&#44; including combined immunodeficiencies&#44; diseases of immune dysregulation&#44; and combined immunodeficiencies with syndromic features&#44; however also present with defects in the humoral system that contribute to an increased susceptibility to infections&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a></p><p id="para0006" class="elsevierStylePara elsevierViewall">Patients with PAD have frequent hospitalizations and immunoglobulin replacement therapy &#40;IgRT&#41;&#44; via intravenous &#40;IVIG&#41; or subcutaneous &#40;IGSC&#41;&#44; is currently the leading therapeutic approach&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">5&#8211;7</span></a> The usual loading dose of IVIG is 400 to 600&#160;mg&#47;kg&#47;dose every 3&#8211;4 weeks&#44; but higher doses between 600 and 800&#160;mg&#47;kg&#47;dose &#40;or up to 1200&#160;mg&#47;kg&#41; may be required and are particularly indicated in case of chronic lung and&#47;or sinus diseases&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">5&#8211;7</span></a></p><p id="para0007" class="elsevierStylePara elsevierViewall">Many studies have reported the benefits of human Ig in reducing episodes of bacterial infections&#44; hospital admission&#44; as well as prevention of chronic pulmonary disease and survival in patients with IEI&#46;<a class="elsevierStyleCrossRefs" href="#bib0006"><span class="elsevierStyleSup">6&#8211;10</span></a> In Brazil IVIG is provided by the government for patients with IEI<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> and&#44; as far as we know&#44; there is no data focusing on the efficacy of IVIG in reducing hospital admission in pediatric Brazilian patients with IEI&#46; The goal of this study was to assess hospital admission&#44; as well as the length of stay &#40;LOS&#41; in children with IEI&#44; pre and one-year post-intravenous immunoglobulin therapy initiation &#40;IVIG&#41; in a tertiary pediatric hospital&#46; Major causes of hospital admission were also evaluated&#46;</p></span><span id="sec0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0008">Methods</span><p id="para0008" class="elsevierStylePara elsevierViewall">A retrospective study was carried out enrolling children with IEI under regular IVIG therapy for at least one year&#44; over the period comprised between 2011 and 2019 in a pediatric tertiary hospital in Brazil&#46; Data were collected from July-2018 to July-2019&#44; by reviewing medical records and interviewing the patient&#39;s family members&#46; The inclusion criteria were &#40;i&#41; age from 1 month of age to 18 years old during the therapy&#59; &#40;ii&#41; diagnosis of IEI based on the diagnostic criteria of the American<a class="elsevierStyleCrossRef" href="#bib0003"><span class="elsevierStyleSup">3</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a> and European Societies for Immunodeficiency<a class="elsevierStyleCrossRef" href="#bib0011"><span class="elsevierStyleSup">11</span></a>&#59; &#40;iii&#41; baseline laboratory tests showing a decrease in serum IgG &#40;at least two standard deviations below the reference mean for age&#41;<a class="elsevierStyleCrossRef" href="#bib0012"><span class="elsevierStyleSup">12</span></a> in minimum two tests and&#47;or impaired vaccine response &#40;rubella&#44; measles&#44; hepatitis B and purified polysaccharide vaccine &#40;23-PPV&#41;<a class="elsevierStyleCrossRef" href="#bib0013"><span class="elsevierStyleSup">13</span></a>&#59; &#40;iv&#41; regular IVIG replacement therapy for at least 12 months&#46; Clinical data collected were&#58; age at onset symptoms&#44; age at diagnosis&#44; IVIG period&#44; lymphocyte counts and immunoglobulin &#40;Ig&#41; serum level pre and post-IVIG &#40;12-months after IVIG initiation&#41;&#44; age at IVIG initiation&#44; diagnostic delay&#44; number of hospital admission&#44; length of stay at hospital and type of infection&#58; a&#41; pneumonia&#59; b&#41; upper respiratory infections &#40;pharyngitis&#44; tonsillitis&#44; sinusitis&#44; and otitis media&#41;&#44; c&#41; others &#40;including gastrointestinal diseases and urinary tract infection&#41;&#46; Pre-IVIG was defined as the period between the first infection and IVIG initiation&#44; and post-IVIG assessment took place 12 months after initiation of IgG therapy&#46; Patients with low IgG in the baseline were allocated into the hypogammaglobulinemia group&#44; their clinical and laboratory data pre and post-IVIG therapy was analyzed independently on the others&#46; Data on antibiotics and immunosuppressive drugs used in association with IVIG during the first year of IVIG were also studied&#46; Diagnosis of SAD was done in children older than 24 months of age with impaired IgG production to the purified polysaccharide vaccine &#40;23-PPV&#41; antigens in the presence of normal immunoglobulin concentrations and normal antibody responses to protein&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0013"><span class="elsevierStyleSup">13</span></a> Patients were tested for a minimum of seven serotypes and 1&#46;3&#160;&#956;g&#47;mL was considered protective IgG concentration for each serotype&#44; according to the literature&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a> Normal antibody response to polysaccharide antigens is defined differently according to age&#58; in children aged 2&#8211;5 years&#44; &#62;50&#37; of concentrations tested are considered protective&#44; with an increase of at least 2- fold observed&#44; and in patients aged 6&#8211;65 years&#44; &#62;70&#37; of concentrations tested are considered protective&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a> Length of stay &#40;LOS&#41; was defined as the duration of hospital stay from the day of hospital admission until the patient&#180;s discharge&#46; Patients were excluded if the follow-up was less than 12 months or noncompliance&#46; The study was approved by the Institutional Research Ethics Committee&#46;</p></span><span id="sec0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0009">Statistical analysis</span><p id="para0009" class="elsevierStylePara elsevierViewall">Data are described as frequency&#44; median&#44; mean&#44; range&#44; and interquartile range &#40;IQR&#41;&#46; Analysis was performed with Graph Pad Prism v&#46;6&#46;05&#174; &#40;GraphPad Software&#44; La Jolla&#44; USA&#41; and IBM SPSS &#40;<span class="elsevierStyleItalic">Statistical</span>&#160;Package&#160;<span class="elsevierStyleItalic">for the</span>&#160;Social&#160;<span class="elsevierStyleItalic">Sciences</span>&#41; &#174; 23&#44; 2015&#46; Kolmogorov-Smirnov&#180;s test was used as a normality test and the Wilcoxon test was used for quantitative and related samples&#46; Mc Nemar test and <span class="elsevierStyleItalic">U</span> Mann&#8211;Whitney tests were used to compare qualitative and quantitative non-parametrical data&#44; respectively&#46; Statistical significance when <span class="elsevierStyleItalic">p</span> value &#60; 0&#46;05&#46;</p></span><span id="sec0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0010">Results</span><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0011">Clinical features of all studied patients</span><p id="para0010" class="elsevierStylePara elsevierViewall">In total 45 children with IEI under IVIG therapy were studied&#44; and most of them were male &#40;<span class="elsevierStyleItalic">n</span>&#160;&#61;&#160;29&#47;64&#46;4&#37;&#41;&#46; The median age at onset of symptoms was six months old and at IVIG initiation was 74mo&#46; Baseline characteristics and Ig levels pre and post-IVIG of all patients are summarized in <a class="elsevierStyleCrossRef" href="#tbl0001">Table 1</a>&#46; Most of the patients &#40;80&#37;&#41; had hypogammaglobulinemia or functional antibody defect &#40;<a class="elsevierStyleCrossRef" href="#tbl0002">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0001"></elsevierMultimedia><elsevierMultimedia ident="tbl0002"></elsevierMultimedia></span><span id="sec0006" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0012">Hypogammaglobulinemic patients</span><p id="para0011" class="elsevierStylePara elsevierViewall">Twenty-two patients were classified in the group hypogammaglobulinemia&#44; most of them were males &#40;81&#46;8&#37;&#41;&#44; and median age of 10 months &#40;3&#8211;180 months&#41; &#40;Supplementary Table 1&#41;&#46; In this group were included patients with CVID &#40;5&#47;22&#41;&#44; XLA &#40;3&#47;22&#41;&#44; and THI &#40;6&#47;22&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0002">Table 2</a>&#41;&#46; The authors also included patients with <span class="elsevierStyleItalic">other hypogammaglobulinemias &#40;OH&#41;</span> &#40;8&#47;22<span class="elsevierStyleItalic">&#41;</span>&#44; which means patients without a well-defined diagnosis&#44; who had a history of recurrent infections and low IgG and&#47;or IgM or IgA&#44; some of these patients had neutropenia &#40;4&#47;21&#41;&#44; others had lymphopenia &#40;3&#47;7&#41;&#46;</p><p id="para0012" class="elsevierStylePara elsevierViewall">The patient with the highest LOS pre-IVIG &#40;167 days&#47;year&#41; was admitted at the age of 2&#46;7 years old&#44; after several hospital admissions&#44; complicated by neurologic sequelae &#40;Supplementary Table 1&#41;&#46; He had pre-IgG levels of 212&#160;mg&#47;dL with normal IgA and IgM&#46; IVIG therapy was initiated in a loading dose of 508&#160;mg&#47;kg&#47;monthly associated with antibiotic prophylaxis&#44; and after 12-months-IVIG&#44; he spent 24 days at the hospital and his IgG levels increased to 984&#160;mg&#47;dL&#46;</p><p id="para0013" class="elsevierStylePara elsevierViewall">The lowest IgG level post -IVIG &#40;478&#160;mg&#47;dL&#41; was observed in a 14-year-old-girl who had CVID phenotype and autoimmune anemia &#40;AIA&#41;&#44; this patient also had the lowest CD4&#43; T cell counts pre and post IVIG&#44; 280&#160;cells&#47;&#181;L and 240&#160;cells&#47;&#181;L&#44; respectively&#46; Perhaps the concomitant use of corticosteroids to treat AIA has influenced her laboratory results&#44; on the other way&#44; she did not require hospital admission in that year&#46;</p><p id="para0014" class="elsevierStylePara elsevierViewall">More than half of hypogammaglobulinemic patients &#40;12&#47;54&#46;5&#37;&#41;&#44; had nearly critical values of IgG serum levels &#40;200&#160;mg&#47;dL&#41; when they were admitted&#46; As the study&#39;s data are retrospective&#44; some patients are not under IVIG therapy anymore&#44; e&#46;g&#46; patients with THI&#46;</p></span><span id="sec0007" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0013">Patients with specific antibody deficiency and complex IEI</span><p id="para0015" class="elsevierStylePara elsevierViewall">In total 14 patients received a diagnosis of SAD&#46; All patients had severe infection leading to hospital admission&#44; and in 10 patients&#44; a chest computed &#40;CT&#41; scan was available&#44; five patients &#40;35&#46;7&#37;&#41; of SAD patients showed some lung abnormality such as atelectasis&#44; bronchiectasis and ground-glass opacity&#46;</p><p id="para0016" class="elsevierStylePara elsevierViewall">Nine patients with well-defined IEI&#44; such as Ataxia-telangiectasia and Chronic Granulomatous Disease with hypogammaglobulinemia &#40;one case each&#41; and Hyper IgE syndrome&#44; &#40;4 cases&#41; were included in this study &#40;<a class="elsevierStyleCrossRef" href="#tbl0002">Table 2</a>&#41;&#46; Purine nucleoside phosphatase &#40;PNP&#41; deficiency and X-linked lymphoproliferative syndrome &#40;XLP&#41; were also diagnosed in two boys&#44; who underwent hematopoietic cell transplantation afterwards&#46;</p><p id="para0017" class="elsevierStylePara elsevierViewall">IVIG dose ranged from 400 to 800&#160;mg&#47;kg &#40;median 517&#160;mg&#47;kg&#41; every three to four weeks&#44; based on the clinical feature and the updated guidelines<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0014"><span class="elsevierStyleSup">14</span></a> &#40;Supplementary Table 2&#41;&#46; The highest loading dose was observed in a patient with Hyper IgM syndrome with several pulmonary sequelae&#44; including bronchiectasis and bronchiolitis obliterans with organizing pneumonia &#40;BOOP&#41;&#44; who was diagnosed at the age of 11yo11months&#44; and onset symptoms at 3yo&#46;</p></span><span id="sec0008" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0014">Number of hospitalization and length of stay &#40;LOS&#41; after IVIG therapy</span><p id="para0018" class="elsevierStylePara elsevierViewall">Almost all patients &#40;44&#47;97&#46;8&#37;&#41; had documented hospital admission prior to IVIG and only 10 patients &#40;24&#37;&#41; post-IVIG&#46; The annual number of hospital admission decreased significantly from 2&#46;5 &#40;median&#58;1&#46;2&#44; range&#58; 0&#8211;30&#41; to 0&#46;5 &#40;median&#58; 0&#44; range&#58;0&#8211;5&#41;&#46; The LOS reduced from 71 days &#40;range&#58; 0&#8211;304&#41; to 4&#46;7 &#40;median&#58; 54&#44; range&#58; 1&#8211;55&#41; per patient &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; <a class="elsevierStyleCrossRef" href="#fig0001">Fig&#46;&#160;1</a>A e 1B&#46; The number of children who required PICU was also significantly reduced from 17 &#40;37&#46;7&#37;&#41; with a mean of LOS of 17&#46;2 days&#47;year &#40;range&#58;1&#8211;150&#41; to zero &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0002&#41; <a class="elsevierStyleCrossRef" href="#fig0001">Fig&#46;&#160;1</a>C&#46;</p><elsevierMultimedia ident="fig0001"></elsevierMultimedia><p id="para0019" class="elsevierStylePara elsevierViewall">One male patient had 30 hospital admissions pre-IVIG&#44; his first immunologic visit was at nine years of age&#44; with a history of recurrent infections since two&#46; He had low IgG&#44; impaired vaccine response&#44; and low CD4&#43; T cells and B cells&#46; After IgRT he had just one hospital admission&#46;</p></span><span id="sec0009" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0015">Reduction in respiratory infection episodes after IVIG</span><p id="para0020" class="elsevierStylePara elsevierViewall">The authors observed a significant reduction in the number of patients hospitalized due to pneumonia&#44; the main cause of hospital admission&#44; from 84&#46;4&#37; to 5&#37;&#46; The number of episodes per patient decreased from an average of 2&#46;2 &#40;median&#58;1&#44; range&#58;0&#8211;14&#41; to 0&#46;1 per year &#40;median&#58;0&#44; range&#58; 0&#8211;2&#41; &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0002">Fig&#46;&#160;2</a>A&#41;&#46; Upper respiratory tract infections &#40;URTI&#41; episodes also reduced&#44; from a mean of 1&#46;1 to 0&#46;1 episode annually&#44; pre and post-IVIG&#44; respectively &#40;<span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0002">Fig&#46;&#160;2</a>B&#41;&#46; Other causes of hospital admission&#44; such as gastroenteritis&#44; urinary infections&#44; surgery were also noted&#44; but in less frequency and not described&#46;</p><elsevierMultimedia ident="fig0002"></elsevierMultimedia></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0016">Concomitant use of antibiotics or immunosuppressive drugs could have influenced the reduction in hospital admissions&#63;</span><p id="para0021" class="elsevierStylePara elsevierViewall">Eleven patients &#40;24&#46;4&#37;&#41; received prophylaxis with antibiotics &#40;azithromycin&#44; amoxicillin and cotrimoxazol&#41; and&#47;or antifungals &#40;itraconazole&#41; during the study period&#46; The authors also noted that four patients &#40;8&#46;9&#37;&#41; received immunosuppressive drugs&#44; such as corticosteroids&#44; cyclosporine and azathioprine&#46; Pulmonary sequelae&#44; autoimmune cytopenia as well as conventional management of some IEI&#44; as HIES and CGD were the reason to prescribe these medications &#40;Supplementary Table 3&#41;&#46;</p><p id="para0022" class="elsevierStylePara elsevierViewall">None data on drugs used previously with IVIG therapy were collected&#46; However&#44; in order to see whether the concomitant use of antibiotics or immunosuppressive drugs associated with IVIG therapy&#44; could have influenced the present study&#39;s results&#44; a comparative analysis was performed&#46; Neither number of hospital admission nor hospital stay was influenced by antibiotics use or immunosuppressive drugs &#40;Supplementary Table 3&#41;<span class="elsevierStyleBold">&#46;</span> Data on the number and type of infections and laboratory results were also studied and&#44; higher IgG and IgM levels post-IVIG in patients taking antibiotics were observed compared to patients without this medication&#44; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;02 and <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;03&#44; respectively&#46;</p></span></span><span id="sec0011" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0017">Discussion</span><p id="para0023" class="elsevierStylePara elsevierViewall">The benefit of human Ig in patients with primary antibody deficiency and in diseases with immune dysregulation related to a genetically defined IEI&#44; is unquestionable and has been well described in other countries&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRefs" href="#bib0008"><span class="elsevierStyleSup">8&#8211;10</span></a> The main purpose of this study was to describe the efficacy of IVIG in reducing the number of hospital admission&#44; LOS&#44; and the number of pneumonia cases in the first year of IVIG replacement therapy and&#44; as far as we know&#44; it is the first study evidencing the impact of Ig therapy in a pediatric cohort with IEI in Brazil&#46;</p><p id="para0024" class="elsevierStylePara elsevierViewall">Forty-five children were studied with a predominance of males&#44; as observed by others and not well understood&#46;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">15</span></a> All patients had recurrent infections&#44; mainly pneumonia&#44; early in life &#40;median 6 months of age&#41;&#46; However&#44; the median duration of diagnostic delay was 63 months&#44; almost the half median age of studied patients &#40;133 months&#41;&#46; It is late considering the advances in techniques to diagnosis IEI in the last decades and also higher than data from Peru and Mexico&#46;<a class="elsevierStyleCrossRef" href="#bib0016"><span class="elsevierStyleSup">16</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0017"><span class="elsevierStyleSup">17</span></a> Previous studies have shown that the earlier the diagnosis of IEI and establishment of suitable treatment&#44; the less is the number and severity of infectious complications and hospital admission&#46;<a class="elsevierStyleCrossRef" href="#bib0009"><span class="elsevierStyleSup">9</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0017"><span class="elsevierStyleSup">17</span></a> The present study&#39;s data suggest a difficulty for general physicians and pediatricians to conceive IEI diagnosis in children with recurrent pneumonia&#44; as well as low awareness of management of IEI&#44; as observed previously in Brazil&#46;<a class="elsevierStyleCrossRef" href="#bib0018"><span class="elsevierStyleSup">18</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0019"><span class="elsevierStyleSup">19</span></a></p><p id="para0025" class="elsevierStylePara elsevierViewall">Human Ig preparations are derived from a plasma pool and contain 95&#8211;99&#37; protective titers of IgG against a large number of pathogens with traces of IgM and IgA&#44; depending on the purification and fractionation process&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0014"><span class="elsevierStyleSup">14</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">20</span></a> Higher IgG serum levels after Ig therapy is expected and correlated with low frequency of infections and hospital admission&#44;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0021"><span class="elsevierStyleSup">21</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0022"><span class="elsevierStyleSup">22</span></a> as the authors observed in patients into the group hypogammaglobulinemia&#46; The authors also noticed a significant reduction in the annual LOS&#44; probably influencing other clinical and social aspects&#44; i&#46;e&#46; use of intravenous antibiotics&#44; growth&#44; and number of absent school days as mentioned by others&#46;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0023"><span class="elsevierStyleSup">23</span></a></p><p id="para0026" class="elsevierStylePara elsevierViewall">Replacement therapy for some groups of IEI is crucial and life-saving&#44; such as XLA&#44; CVID&#44; and severe combined immunodeficiency &#40;SCID&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a> Other genetically complex IEI&#44; such as Wiskott-Aldrich syndrome&#44; Ataxia-telangiectasia&#44; XLP&#44; Hyper E and IgM syndromes&#44; also have defects in antibody production or function that contribute to an increased susceptibility to infections and the benefits of IgRT has been described&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a></p><p id="para0027" class="elsevierStylePara elsevierViewall">Consensus recommendations for the use of human Ig replacement are&#58; serum IgG &#60; 200&#160;mg&#47;dL&#44; which is always an indication&#44; except for patients with transient hypogammaglobulinemia of infancy with no severe infections&#59; serum IgG between 200 and 500&#160;mg&#47;dL is an indication in case of antibody production deficiency or recurrent and&#47;or severe infections&#59; serum IgG &#62; 500&#160;mg&#47;dL is an indication for Ig replacement only when abnormal production of specific antibodies is verified&#44; and recurrent and severe infections are present&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0014"><span class="elsevierStyleSup">14</span></a></p><p id="para0028" class="elsevierStylePara elsevierViewall">In young children&#44; especially infants&#44; with low antibody production&#44; the definitive diagnosis can be very difficult&#46; It can result from an immaturity of the immune system or transient impaired production&#46;<a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0011"><span class="elsevierStyleSup">11</span></a> Nevertheless&#44; patients with IgG levels below 200&#160;mg&#47;dL with a previous history of severe infections requiring hospital admission&#44; are a candidate for Ig replacement due to the high risk of complications&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> According to Schartoj&#233; and colleagues&#44; it is impossible to predict which child will recover and which one will suffer from a more or less severe disease in the future&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">15</span></a> Recently Janssen and others&#44; evaluating patients &#40;adults and children&#41; with unclassified hypogammaglobulinemia &#40;unPAD&#41;&#44; alert that these patients can have comorbidities similar to other well-defined IEI&#44; influencing their quality of life&#46;<a class="elsevierStyleCrossRef" href="#bib0024"><span class="elsevierStyleSup">24</span></a></p><p id="para0029" class="elsevierStylePara elsevierViewall">Diagnosis of SAD is also not so easy to establish&#44; it involves a careful clinical and laboratory evaluation&#46; In Brazil it has been a challenge to perform this diagnosis in the public health system&#46; According to Costa-Carvalho et al&#46; in a survey involving 17 Brazilian public reference centers of Immunology&#44; fewer than 10&#37; of clinical immunologists were able to evaluate the response to the pneumococcus polysaccharide vaccine&#46; In the present study&#44; the diagnosis was done evaluating a minimum of seven serotypes&#46; Perhaps the authors have lost some diagnosis during the eight-year period&#44; but patients with diagnosis SAD described in this study had documented recurrent or severe respiratory infections and poor response to pneumococcal polysaccharide vaccination&#59; besides&#44; most of them had pulmonary sequelae on chest CT scan&#46;</p><p id="para0030" class="elsevierStylePara elsevierViewall">It&#180;s important to keep in mind that Ig therapy is not recommended in all patients with SAD&#46; The therapeutic strategies depend on the clinical manifestation and include an additional dose with conjugated pneumococcal&#44; antibiotic prophylaxis&#44; and Ig replacement therapy&#46; Among them&#44; antibiotic prophylaxis has been described as the mainstay of therapy for patients with SAD&#46;<a class="elsevierStyleCrossRef" href="#bib0013"><span class="elsevierStyleSup">13</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">25</span></a></p><p id="para0031" class="elsevierStylePara elsevierViewall">Perez et&#160;al&#46; described some features to consider Ig therapy in patients with SAD&#44; including&#58; i&#46; severe or very frequent recurrent infections&#59; ii&#46; inability to tolerate antibiotic prophylaxis due to multiple hypersensitivities&#44; severe side effects or complications such as Clostridium difficile colitis&#44; etc&#46;&#59; or iii&#46; failure to respond to prophylactic antibiotics <span class="elsevierStyleSup">25</span>&#46; In this study&#44; the authors also took into account abnormalities on chest CT scan as recommended in the Brazilian consensus on IgRT&#46;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a></p><p id="para0032" class="elsevierStylePara elsevierViewall">Prior to IVIG 17 children &#40;37&#46;8&#37;&#41; required intensive care&#44; suggesting a poor clinical status associated infections with a high risk to develop sequela&#44; especially chronic pulmonary disease&#46; The efficacy of IVIG in reducing the number as well the severity of infections was remarkable and it may have had a positive impact on the economic burden to the Brazilian health care system&#44; taking into account the high daily cost of an intensive care unit day and&#44; also that none patient was admitted in the PICU in the first 12 months of Ig therapy&#46; Further studies on these results and economic impacts would be required&#46;</p><p id="para0033" class="elsevierStylePara elsevierViewall">Most of the patients &#40;84&#46;4&#37;&#41; had experienced at least 1 episode of pneumonia leading to hospital admission prior to IVIG&#46; The occurrence of bacterial respiratory infections is the main clinical presentation of IEI&#44; and many patients experience multiple episodes before the diagnosis&#46;<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0018"><span class="elsevierStyleSup">18</span></a> Orange and colleagues described that the prevalence of pneumonia and the pneumonia risk was inversely correlated with high IgG levels &#40;up to at least 1000&#160;mg&#47;dL&#41; in patients with hypogammaglobulinemia&#46;<a class="elsevierStyleCrossRef" href="#bib0022"><span class="elsevierStyleSup">22</span></a> On the other hand&#44; Quinti et al&#46;&#44; correlated the high number of pneumonia with low IgA levels pre and post- IVIG in CVID patients&#46;<a class="elsevierStyleCrossRef" href="#bib0021"><span class="elsevierStyleSup">21</span></a> In this study&#44; no difference was noted between IgA levels pre and post-treatment&#44; and as the study cohort included complex IEI and SAD patients&#44; the significant reduction in pneumonia episodes after IVIG treatment suggest that not only IgG levels per se&#44; but also IgG function were balanced in the first year of Ig therapy&#46;</p><p id="para0034" class="elsevierStylePara elsevierViewall">This study has some limitations&#44; as the heterogeneity of IEI diseases&#44; absent detailed data about chronic lung disease&#44; and infections others than the respiratory tract&#46; However&#44; the authors highlight for the first time the efficacy of IVIG replacement therapy in Brazilian children with IEI&#44; in reducing hospital admission&#44; LOS&#44; and number of pneumonia&#46; The authors expect that the present study data can help physicians&#44; especially pediatricians&#44; to be alert of a possible diagnosis of IEI in cases of recurrent or severe pneumonia leading to hospital admission&#44; and to consider IgRT if necessary&#46;</p></span><span id="sec0012" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0018">Funding</span><p id="para0035" class="elsevierStylePara elsevierViewall">LMA&#44; Scholarship &#40;August&#46;2018 to July&#46;2019&#41; has been provided by Instituto do C&#226;ncer Infantil e Pediatria Especializada&#47; Hospital da Crian&#231;a de Bras&#237;lia Jos&#233; Alencar&#46;</p></span></span>"
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              "titulo" => "Clinical features of all studied patients"
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              "titulo" => "Hypogammaglobulinemic patients"
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              "titulo" => "Patients with specific antibody deficiency and complex IEI"
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              "titulo" => "Number of hospitalization and length of stay &#40;LOS&#41; after IVIG therapy"
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              "titulo" => "Reduction in respiratory infection episodes after IVIG"
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              "titulo" => "Concomitant use of antibiotics or immunosuppressive drugs could have influenced the reduction in hospital admissions&#63;"
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    "fechaRecibido" => "2021-03-17"
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            0 => "Primary immunodeficiency"
            1 => "Inborn Errors of Immunity"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abss0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0002">Objectives</span><p id="spara006" class="elsevierStyleSimplePara elsevierViewall">To compare the frequency of hospitalization in children with Inborn Errors of Immunity with antibody deficiency previous to intravenous immunoglobulin &#40;pre- IVIG&#41; with a one-year period after initial IVIG &#40;post-IVIG&#41;&#46;</p></span> <span id="abss0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0003">Methods</span><p id="spara007" class="elsevierStyleSimplePara elsevierViewall">Medical reports of 45 patients during an eight-year period were reviewed from 2018 to 2019&#46; Wilcoxon-test was used for related samples&#46;</p></span> <span id="abss0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Results</span><p id="spara008" class="elsevierStyleSimplePara elsevierViewall">Forty-five children were included in the study&#44; aged 29&#8211;249 months of age&#44; and most of them &#40;64&#46;4&#37;&#41; were males&#46; Median ages at onset symptoms and at diagnosis were 6 and 73 months old&#44; respectively&#46; Specific antibody deficiency and unclassified hypogammaglobulinemia were the predominant diagnoses &#40;31&#46;1&#37; and 17&#46;8&#37;&#44; respectively&#41;&#46; X-linked agammaglobulinemia&#44; Hyper IgE syndrome&#44; Hyper IgM&#44; transient hypogammaglobulinemia of infancy&#44; and Common Variable Immunodeficiency &#40;CVID&#41; were also reported&#44; in a low frequency&#46; Forty-four &#40;97&#46;8&#37;&#41; patients were hospitalized before IVIG&#44; and 10 patients &#40;22&#46;2&#37;&#41; after&#46; Annual mean hospital admission reduced from 2&#46;5 to 0&#46;5&#44; pre and post-IVIG&#44; respectively &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; Mean length of stay &#40;LOS&#41; reduced from 71 to 4&#46;7 days&#47;year &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; in general ward and in the PICU from 17&#46;2 days&#47;year to zero &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0002&#41;&#46; Pneumonia was the main cause of hospital admission with a reduction in the number of episodes per patient from an average of 2&#46;2&#8211;0&#46;1 per year &#40;<span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;001&#41;&#46; Concomitant use of antibiotic prophylaxis did not influence the number of hospital admission&#46;</p></span> <span id="abss0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0005">Conclusion</span><p id="spara009" class="elsevierStyleSimplePara elsevierViewall">One-year intravenous IVIG significantly decreased the number of hospitalizations and length of stay in children with impaired antibody production&#46; Social and economic impacts would be required&#46;</p></span>"
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                  \t\t\t\t  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="" valign="top">Current age in months&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="top">133 &#40;29&#8211;249&#41;&nbsp;\t\t\t\t\t\t\n
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        "texto" => "<p id="para0038" class="elsevierStylePara elsevierViewall">The authors thank Prof&#46; Beatriz T&#46; Costa-Carvalho &#40;<span class="elsevierStyleItalic">in memorian</span>&#41; for her contribution to clinical immunology studies in Brazil and Larissa Souza for statistical analysis support&#46;</p>"
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Article information
ISSN: 00217557
Original language: English
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