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      "titulo" => "Two difficult management autoimmune diseases"
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    "titulo" => "Exposure to belimumab in the first trimester of pregnancy in a young woman with systemic lupus erythematosus"
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            "nombre" => "Ignacio Javier"
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        "titulo" => "Exposici&#243;n a belimumab en el primer trimestre de embarazo en una mujer joven con lupus eritematoso sist&#233;mico"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Mister editor&#44; belimumab is a fully human IgG1-&#955; monoclonal antibody that binds to soluble human B-cell survival factor &#40;known as BLyS or BAFF&#41; and inhibits its biological activity&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> Belimumab was approved for treatment of systemic lupus erythematosus &#40;SLE&#41; because it showed superiority to the standard of care&#44; excluding patients with active nephritis or central nervous system disease&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">1&#44;2</span></a> Here&#44; we report a case of a SLE patient that was incidentally exposed to belimumab during the first trimester of pregnancy&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">A 27-year-old Caucasian female with SLE has been followed for this disease for 10 years&#46; She began with arthritis in her hands&#44; malar rash&#44; oral ulcers&#44; and serositis&#46; Her immunology laboratory had ANA 1&#47;1280&#44; homogenous nuclear pattern&#44; positive anti-dsDNA&#44; positive anti Ro and positive lupus anticoagulant&#44; as well as low C3 and C4 complement levels&#46; She followed treatments with corticosteroids&#44; hydroxychloroquine and methotrexate&#44; with a good initial response&#44; but effectiveness decreased over time&#46; She started to be refractory concerning serositis&#44; arthritis&#44; oral ulcers and skin abnormalities related to these medications&#44; and never had lupus nephritis or neurological compromise&#46; Treatment with belimumab began two years before pregnancy&#46; During this time the disease was successfully controlled&#44; with 0 SLEDAI &#40;SLE Disease Activity Index&#41; points and without adverse events&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">She discontinued coming to medical controls&#59; and during this time she got pregnant&#46; When controls were resumed&#44; at week twelve of pregnancy&#44; belimumab was stopped&#46; Her pregnancy was successful&#44; with no SLE reactivation&#46; At week 39&#46;6&#44; due to oligohydramnios and lack of adequate progression&#44; she underwent a cesarean section without any complication&#46; The weight of the newborn was 3520 grams&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">This case was an accidental condition&#44; where the patient did not follow her medical controls and never referred to a rheumatologist for pre-pregnancy counseling&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Belimumab was well tolerated at pharmacologically active dose levels in pregnant monkeys and their infants after exposure throughout pregnancy&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> No formal clinical studies have been conducted in pregnant women&#46;<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">4&#44;5</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The Belimumab Pregnancy Registry &#40;BPR&#41; aims to evaluate pregnancy and infant outcomes in women with SLE exposed to belimumab within the 4 months prior to and&#47;or during pregnancy&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">6</span></a> Data of clinical trial outcomes&#44; spontaneous pregnancy reports&#44; and post-marketing surveillance reports outside of the BPR have reported a total of 275 pregnancies&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a> Total outcomes&#44; BPR and non-BPR&#44; eight were live births with apparent congenital anomaly&#46; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows these outcomes&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a> The congenital abnormalities reported in live infants of patients exposed to belimumab included Dandy Walker syndrome&#44; bilateral enlarged kidneys&#44; pulmonic stenosis&#44; mild Ebstein anomaly&#44; unbalanced translocation between chromosomes 11 and 13&#44; bilateral club foot&#44; and ventricular septal defect&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">The EULAR points for use of belimumab before pregnancy&#44; during pregnancy and lactation is that there is limited documentation and should be replaced before conception by other medication&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> The British Society for Rheumatology &#40;BSR&#41; and the British Health Professionals in Rheumatology &#40;BHPR&#41; guideline announces a similar statement&#44; saying that there is insufficient data to recommend belimumab in pregnancy and an unintentional first trimester exposure is unlikely to be harmful&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">There is insufficient evidence to prove absolute safety for use belimumab during pregnancy&#46; We need human clinical studies evaluating the use of belimumab in pregnant women to know the usefulness and safety of this drug&#46; Over time&#44; data from the BPR would be useful to assess safety of this agent for use in pregnancy SLE patients&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">5</span></a></p></span>"
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                  \t\t\t\t"><span class="elsevierStyleItalic">Total pregnancies</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">275&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Lost to follow up or unknown&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">45&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Pregnancy ongoing&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">36&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">38&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Total pregnancies with known outcomes</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Elective termination with no apparent congenital anomaly&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Elective termination with congenital anomaly&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Total pregnancies with known outcomes excluding elective terminations</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">47&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                        0 => array:2 [
                          "etal" => true
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                            2 => "R&#46;A&#46; Furie"
                            3 => "J&#46;R&#46; Lisse"
                            4 => "J&#46;D&#46; McKay"
                            5 => "J&#46;T&#46; Merrill"
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                        "paginaInicial" => "1168"
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                        "paginaInicial" => "443"
                        "paginaFinal" => "455"
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                0 => array:1 [
                  "referenciaCompleta" => "Use of intravenous &#40;IV&#41; benlysta in pregnant patients with systemic lupus erythematosus &#40;SLE&#41;&#46; GlaxoSmithKline Data on File&#46;"
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