Effectiveness of belimumab in the treatment of lupus nephritis: analysis of 8 cases

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Bone balance behaviour is not represented." ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Jesús González Macías, José Manuel Olmos Martínez" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Jesús" "apellidos" => "González Macías" ] 1 => array:2 [ "nombre" => "José Manuel" "apellidos" => "Olmos Martínez" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0025775322001804" "doi" => "10.1016/j.medcli.2022.04.003" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775322001804?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020622004326?idApp=UINPBA00004N" "url" => "/23870206/0000015900000007/v2_202301310815/S2387020622004326/v2_202301310815/en/main.assets" ] "en" => array:18 [ "idiomaDefecto" => true "cabecera" => "Clinical report" "titulo" => "Effectiveness of belimumab in the treatment of lupus nephritis: analysis of 8 cases" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "344" "paginaFinal" => "346" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Marta de la Rubia Navarro, José Rafael Ivorra Cortés, Elena Grau García, José Andrés Román Ivorra" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Marta" "apellidos" => "de la Rubia Navarro" "email" => array:1 [ 0 => "mardena@mail.ucv.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "José Rafael" "apellidos" => "Ivorra Cortés" ] 2 => array:2 [ "nombre" => "Elena" "apellidos" => "Grau García" ] 3 => array:2 [ "nombre" => "José Andrés" "apellidos" => "Román Ivorra" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Reumatología, Hospital Universitari i Politècnic La Fe, Valencia, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Efectividad de belimumab en el tratamiento de la nefritis lúpica: análisis de 8 casos" ] ] "textoCompleto" => "IntroductionSystemic lupus erythematosus (SLE) is a clinically heterogeneous, multiorgan autoimmune disease characterized by an overproduction of autoantibodies and immune complex (IC) deposition. Both genetic and environmental factors influence the development of the disease.<a class="elsevierStyleCrossRefs" href="#bib0005">1,2</a>The diverse clinical manifestations reflect the complexity and heterogeneity of the disease. Among these, lupus nephritis (LN) is one of the most serious, is present in 30–50% of patients and usually determines the prognosis.<a class="elsevierStyleCrossRef" href="#bib0015">3</a> In relation to its development, the deposition of immunocomplexes is primarily responsible and therefore the B-cell takes on a key role as an autoantibody producer.<a class="elsevierStyleCrossRef" href="#bib0015">3</a> Despite the greater knowledge of the pathogenesis and treatment of the disease, about 10% of patients with LN progress to end-stage renal disease and, in the case of LN type IV, up to 40% develop this complication.<a class="elsevierStyleCrossRefs" href="#bib0010">2,4</a>Currently, the standard treatment of lupus nephritis (classes III, IV and V) is based on immunosuppression regimens that include an induction phase of about 3–6 months in which boluses of methylprednisolone are administered combined with cyclophosphamide or mycophenolate mofetil, followed by a maintenance phase, which is associated with less toxicity.<a class="elsevierStyleCrossRef" href="#bib0020">4</a>Belimumab was approved in 2011, a monoclonal antibody that binds to the BLyS protein, which is involved in the survival of B cells, thus preventing their differentiation and limiting their survival.<a class="elsevierStyleCrossRef" href="#bib0025">5</a> The effectiveness of belimumab added to standard therapy over placebo added to standard therapy has been demonstrated in 4 randomized clinical trials.<a class="elsevierStyleCrossRefs" href="#bib0025">5,6</a> The results of a randomised, double-blind, placebo-controlled, randomised, double-blind phase III clinical trial in patients with renal biopsy-documented active LN4 were published in 2020.<a class="elsevierStyleCrossRefs" href="#bib0020">4,7</a> 446 patients were randomised to receive belimumab plus standard therapy (cyclophosphamide or mycophenolate mofetil) or placebo plus standard therapy.<a class="elsevierStyleCrossRef" href="#bib0035">7</a> The results demonstrated the superiority of belimumab associated with standard therapy to achieve the primary objective (43% vs. 32%; OR: 1.65; 95% CI: 1.0–2.3; p=0.03).<a class="elsevierStyleCrossRef" href="#bib0035">7</a>The objective is to analyse the efficacy of belimumab associated with standard therapy in real clinical practice, in terms of renal function and serological activity, in patients with LN under follow-up in a reference hospital.Material and methodsThis is an observational, cross-sectional, retrospective study that includes adult patients diagnosed with SLE with biopsy-proven kidney involvement, coming from the rheumatology department of a tertiary hospital.All patients met the SLICC/ACR 2012 criteria and received treatment with intravenous and/or subcutaneous belimumab (10mg/kg every 28 days or 200mg weekly), along with standard therapy. Patients under 18 years of age who did not have lupus glomerulonephritis and those not treated with belimumab were excluded.A review of clinical records was carried out and data were collected regarding clinical-demographic variables such as age, sex, time of condition progression, concomitant treatments, data on serological activity, urinary sediment and renal function (creatinine and glomerular filtration).ResultsOf a total of 29 patients treated with belimumab, 8 had LN confirmed by renal biopsy. The criterion for starting belimumab was based on the presence of serological activity (high anti-DNA, low complement) associated with musculoskeletal and/or skin manifestations. Only in one case (patient 8) was it initiated due to lupus nephritis.Among the patients with LN, the mean age was 37.56 (7.03) years, with 15.13 (8.71) years of disease progression and 4.61 (2.64) years from the start of belimumab. Type III was the most prevalent (33.3%), followed by type IV (22.22%). Two patients had the combination of types III-V (22.22%) and only one patient with type V LN (11.11%).As detailed in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>, there was a reduction in proteinuria until complete resolution in 6 patients, with renal function remaining virtually stable from the start of treatment in all cases. With regard to serological activity, there was a reduction in anti-DNA antibody levels, as well as a return to normal serum complement values in cases where it was reduced. An increase in anti-DNA titre was recorded in one of the patients, maintaining normal complement levels at all times.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>DiscussionIt is currently very difficult to compare results from different studies using a single parameter assessing therapeutic efficacy or renal response, as most use different definitions in terms of clinical manifestations or therapeutic response.<a class="elsevierStyleCrossRef" href="#bib0040">8</a>A systematic review published in 2017 describes 7 patients with active renal biopsy treated with belimumab with a therapeutic response rate of 100%. The percentage of women is very similar to the present study (86%), most had type IV LN and only one patient started with type V LN.<a class="elsevierStyleCrossRef" href="#bib0040">8</a> This same study indicates that of 234 patients with LN treated with belimumab in the period from 2013 to 2016, 129 (55.1%) showed a clear improvement in the parameters measured by the SELENA-SLEDAI, SLEADAI-2k, and BILAG and/or SLAM scores. In addition, those with baseline proteinuria >0.2g/24h experienced a 38% reduction in proteinuria and, among those with proteinuria >1g/24h, 70.7% treated with belimumab achieved remission of renal activity.A more recent series evaluating the efficacy of intravenous belimumab in LN included 17 women with a median of 8.1 years from the start of belimumab, very similar to our sample.<a class="elsevierStyleCrossRef" href="#bib0045">9</a> Among the most remarkable results, in 3 of the 8 patients with kidney biopsy-detected nephritis, proteinuria was reduced to <0.5g/day and in 4 patients it remained stable during the 37.5 months of observation. In addition, 3 patients were able to reduce corticosteroid therapy until it was discontinued, after 24, 36 and 36 months, respectively. Regarding serological activity, C3 levels increased in a statistically significant way, returning to normal levels in 3 patients. Finally, anti-DNA antibody levels achieved normal levels in 3 of 13 patients.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>In conclusion, in real life belimumab can improve LN in terms of serological activity, renal function and urinary sediment, and could be a good option in combination with standard therapy. However, as future objectives, we propose standardizing the definition of therapeutic efficacy in terms of renal response in order to be able to compare studies and draw common conclusions." "textoCompletoSecciones" => array:1 [ "secciones" => array:9 [ 0 => array:3 [ "identificador" => "xres1839907" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1603389" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1839906" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción y objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1603388" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Material and methods" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Discussion" ] 8 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2022-03-28" "fechaAceptado" => "2022-05-18" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1603389" "palabras" => array:2 [ 0 => "Lupus nephritis" 1 => "Belimumab" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1603388" "palabras" => array:2 [ 0 => "Nefritis lúpica" 1 => "Belimumab" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "Background and objectiveBelimumab is a monoclonal antibody targeting BLyS approved for Systemic Lupus Erythematosus (SLE), with recent indication for lupus nephritis (LN).To analyze effectiveness of Belimumab in LN patients. MethodsRetrospective and cross-sectional study including SLE patients (SLICC/ACR 2012 criteria) with LN demonstrated by kidney biopsy, treated with Belimumab. A clinical history review was made and serological data, kidney function and urine sediment were collected. ResultsEight patients with LN demonstrated by kidney biopsy were included. Median age was 37.56 (7.03) years, with 15.13 (8.71) years since SLE diagnosis was made and 4.61 (2.64) years since onset of belimumab.Proteinuria was reduced to normal values in 6 patients, and renal function was stable from the beginning of treatment in all cases. There was a reduction in the anti-DNA level and normalization of complement in those cases in which it was reduced. One patient presented an increase in anti-DNA titer, with normal complement. ConclusionsIn clinical practice, belimumab can improve LN in terms of serological activity, kidney function and urine sediment." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "Introducción y objetivoBelimumab es un anticuerpo monoclonal aprobado para pacientes con lupus eritematoso sistémico (LES), con indicación reciente para nefritis lúpica (NL).El objetivo es analizar la eficacia de Belimumab en pacientes con NL. MétodosEstudio transversal, retrospectivo, que incluye pacientes diagnosticados de LES (criterios SLICC/ACR 2012), con nefritis demostrada mediante biopsia, tratados con Belimumab. Se recogieron datos serológicos, función renal (creatinina, filtrado glomerular) y sedimento urinario. ResultadosSe incluyen 8 pacientes con edad media de 37,56 (7,03) años, con 15,13 (8,71) años de evolución de la enfermedad y 4,61 (2,64) años desde el inicio de belimumab.La proteinuria se redujo hasta alcanzar valores normales en 6 pacientes, manteniéndose la función renal estable desde el inicio del tratamiento en todos los casos. Se registró una reducción del nivel de anti-DNA y una normalización del complemento en los casos en que estaba reducido. En uno de los pacientes se registró un aumento del título de anti-DNA, manteniéndose el complemento normal. ConclusionesEn práctica clínica real, belimumab puede mejorar la NL en términos de actividad serológica, función renal y sedimento urinario." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción y objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "Normal levels of anti-DNA: <15IU/mL; C3 normal range: 82−185mg/dl; and C4: 15−53mg/dl." "tablatextoimagen" => array:1 [ 0 => array:1 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_colgroup " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Baseline</th><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_colgroup " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Follow-up</th></tr><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Patient \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">LN type \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Proteinuria (g/24h) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Creatinine (mg/dl) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Glomerular filtration rate (ml/min) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Anti-DNA \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">C3, C4 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Proteinuria (g/24h) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Creatinine (mg/dl) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Glomerular filtration rate (ml/min) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Anti-DNA \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">C3, C4 \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">III \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.81 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">90 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">50 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">80, 8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.73 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">89 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">80, 20 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">V \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.75 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.40 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">130 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Normal \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.49 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">130 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">43 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Normal \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">III \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.75 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.73 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">101 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">164 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Normal \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.80 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">82.9 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">78 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Normal \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">IV \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.26 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">55 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">21 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Normal \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.70 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.29 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">71 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2.2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Normal \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">IV \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.95 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.29 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">71 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">15 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">101, 10 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.88 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">84 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">85 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">89, 23 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">III-V \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.67 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">113 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">108 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">57, 8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.10 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.75 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">101 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">57 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">50, 15 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">III-V \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.86 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.70 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">129 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">51, 18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.27 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.86 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">118 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">59, 17 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">III \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.68 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">119 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">378 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">67, 11 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.69 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">117 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">83 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">96, 23 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] ] ] ] "descripcion" => array:1 [ "en" => "Laboratory findings at baseline and during follow-up." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:9 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Systemic lupus erythematosus" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "A. 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Clinical report

Effectiveness of belimumab in the treatment of lupus nephritis: analysis of 8 cases

Efectividad de belimumab en el tratamiento de la nefritis lúpica: análisis de 8 casos

Marta de la Rubia Navarro

Corresponding author

mardena@mail.ucv.es

Corresponding author.

, José Rafael Ivorra Cortés, Elena Grau García, José Andrés Román Ivorra

Servicio de Reumatología, Hospital Universitari i Politècnic La Fe, Valencia, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Systemic lupus erythematosus &#40;SLE&#41; is a clinically heterogeneous&#44; multiorgan autoimmune disease characterized by an overproduction of autoantibodies and immune complex &#40;IC&#41; deposition&#46; Both genetic and environmental factors influence the development of the disease&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The diverse clinical manifestations reflect the complexity and heterogeneity of the disease&#46; Among these&#44; lupus nephritis &#40;LN&#41; is one of the most serious&#44; is present in 30&#8211;50&#37; of patients and usually determines the prognosis&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> In relation to its development&#44; the deposition of immunocomplexes is primarily responsible and therefore the B-cell takes on a key role as an autoantibody producer&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Despite the greater knowledge of the pathogenesis and treatment of the disease&#44; about 10&#37; of patients with LN progress to end-stage renal disease and&#44; in the case of LN type <span class="elsevierStyleSmallCaps">IV</span>&#44; up to 40&#37; develop this complication&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Currently&#44; the standard treatment of lupus nephritis &#40;classes <span class="elsevierStyleSmallCaps">III</span>&#44; <span class="elsevierStyleSmallCaps">IV</span> and <span class="elsevierStyleSmallCaps">V</span>&#41; is based on immunosuppression regimens that include an induction phase of about 3&#8211;6 months in which boluses of methylprednisolone are administered combined with cyclophosphamide or mycophenolate mofetil&#44; followed by a maintenance phase&#44; which is associated with less toxicity&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Belimumab was approved in 2011&#44; a monoclonal antibody that binds to the BLyS protein&#44; which is involved in the survival of B cells&#44; thus preventing their differentiation and limiting their survival&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> The effectiveness of belimumab added to standard therapy over placebo added to standard therapy has been demonstrated in 4 randomized clinical trials&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a> The results of a randomised&#44; double-blind&#44; placebo-controlled&#44; randomised&#44; double-blind phase <span class="elsevierStyleSmallCaps">III</span> clinical trial in patients with renal biopsy-documented active LN4 were published in 2020&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;7</span></a> 446 patients were randomised to receive belimumab plus standard therapy &#40;cyclophosphamide or mycophenolate mofetil&#41; or placebo plus standard therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> The results demonstrated the superiority of belimumab associated with standard therapy to achieve the primary objective &#40;43&#37; vs&#46; 32&#37;&#59; OR&#58; 1&#46;65&#59; 95&#37; CI&#58; 1&#46;0&#8211;2&#46;3&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;03&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The objective is to analyse the efficacy of belimumab associated with standard therapy in real clinical practice&#44; in terms of renal function and serological activity&#44; in patients with LN under follow-up in a reference hospital&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Material and methods</span><p id="par0030" class="elsevierStylePara elsevierViewall">This is an observational&#44; cross-sectional&#44; retrospective study that includes adult patients diagnosed with SLE with biopsy-proven kidney involvement&#44; coming from the rheumatology department of a tertiary hospital&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">All patients met the SLICC&#47;ACR 2012 criteria and received treatment with intravenous and&#47;or subcutaneous belimumab &#40;10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg every 28 days or 200<span class="elsevierStyleHsp" style=""></span>mg weekly&#41;&#44; along with standard therapy&#46; Patients under 18 years of age who did not have lupus glomerulonephritis and those not treated with belimumab were excluded&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">A review of clinical records was carried out and data were collected regarding clinical-demographic variables such as age&#44; sex&#44; time of condition progression&#44; concomitant treatments&#44; data on serological activity&#44; urinary sediment and renal function &#40;creatinine and glomerular filtration&#41;&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">Of a total of 29 patients treated with belimumab&#44; 8 had LN confirmed by renal biopsy&#46; The criterion for starting belimumab was based on the presence of serological activity &#40;high anti-DNA&#44; low complement&#41; associated with musculoskeletal and&#47;or skin manifestations&#46; Only in one case &#40;patient 8&#41; was it initiated due to lupus nephritis&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Among the patients with LN&#44; the mean age was 37&#46;56 &#40;7&#46;03&#41; years&#44; with 15&#46;13 &#40;8&#46;71&#41; years of disease progression and 4&#46;61 &#40;2&#46;64&#41; years from the start of belimumab&#46; Type <span class="elsevierStyleSmallCaps">III</span> was the most prevalent &#40;33&#46;3&#37;&#41;&#44; followed by type <span class="elsevierStyleSmallCaps">IV</span> &#40;22&#46;22&#37;&#41;&#46; Two patients had the combination of types <span class="elsevierStyleSmallCaps">III</span>-<span class="elsevierStyleSmallCaps">V</span> &#40;22&#46;22&#37;&#41; and only one patient with type <span class="elsevierStyleSmallCaps">V</span> LN &#40;11&#46;11&#37;&#41;&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">As detailed in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#44; there was a reduction in proteinuria until complete resolution in 6 patients&#44; with renal function remaining virtually stable from the start of treatment in all cases&#46; With regard to serological activity&#44; there was a reduction in anti-DNA antibody levels&#44; as well as a return to normal serum complement values in cases where it was reduced&#46; An increase in anti-DNA titre was recorded in one of the patients&#44; maintaining normal complement levels at all times&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0060" class="elsevierStylePara elsevierViewall">It is currently very difficult to compare results from different studies using a single parameter assessing therapeutic efficacy or renal response&#44; as most use different definitions in terms of clinical manifestations or therapeutic response&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">A systematic review published in 2017 describes 7 patients with active renal biopsy treated with belimumab with a therapeutic response rate of 100&#37;&#46; The percentage of women is very similar to the present study &#40;86&#37;&#41;&#44; most had type <span class="elsevierStyleSmallCaps">IV</span> LN and only one patient started with type <span class="elsevierStyleSmallCaps">V LN</span><span class="elsevierStyleSmallCaps">&#46;</span><a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> This same study indicates that of 234 patients with LN treated with belimumab in the period from 2013 to 2016&#44; 129 &#40;55&#46;1&#37;&#41; showed a clear improvement in the parameters measured by the SELENA-SLEDAI&#44; SLEADAI-2k&#44; and BILAG and&#47;or SLAM scores&#46; In addition&#44; those with baseline proteinuria &#62;0&#46;2<span class="elsevierStyleHsp" style=""></span>g&#47;24<span class="elsevierStyleHsp" style=""></span>h experienced a 38&#37; reduction in proteinuria and&#44; among those with proteinuria &#62;1<span class="elsevierStyleHsp" style=""></span>g&#47;24<span class="elsevierStyleHsp" style=""></span>h&#44; 70&#46;7&#37; treated with belimumab achieved remission of renal activity&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">A more recent series evaluating the efficacy of intravenous belimumab in LN included 17 women with a median of 8&#46;1 years from the start of belimumab&#44; very similar to our sample&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Among the most remarkable results&#44; in 3 of the 8 patients with kidney biopsy-detected nephritis&#44; proteinuria was reduced to &#60;0&#46;5<span class="elsevierStyleHsp" style=""></span>g&#47;day and in 4 patients it remained stable during the 37&#46;5 months of observation&#46; In addition&#44; 3 patients were able to reduce corticosteroid therapy until it was discontinued&#44; after 24&#44; 36 and 36 months&#44; respectively&#46; Regarding serological activity&#44; C3 levels increased in a statistically significant way&#44; returning to normal levels in 3 patients&#46; Finally&#44; anti-DNA antibody levels achieved normal levels in 3 of 13 patients&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">In conclusion&#44; in real life belimumab can improve LN in terms of serological activity&#44; renal function and urinary sediment&#44; and could be a good option in combination with standard therapy&#46; However&#44; as future objectives&#44; we propose standardizing the definition of therapeutic efficacy in terms of renal response in order to be able to compare studies and draw common conclusions&#46;</p></span></span>"
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    "fechaRecibido" => "2022-03-28"
    "fechaAceptado" => "2022-05-18"
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    "resumen" => array:2 [
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objective</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Belimumab is a monoclonal antibody targeting BLyS approved for Systemic Lupus Erythematosus &#40;SLE&#41;&#44; with recent indication for lupus nephritis &#40;LN&#41;&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">To analyze effectiveness of Belimumab in LN patients&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Retrospective and cross-sectional study including SLE patients &#40;SLICC&#47;ACR 2012 criteria&#41; with LN demonstrated by kidney biopsy&#44; treated with Belimumab&#46; A clinical history review was made and serological data&#44; kidney function and urine sediment were collected&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Eight patients with LN demonstrated by kidney biopsy were included&#46; Median age was 37&#46;56 &#40;7&#46;03&#41; years&#44; with 15&#46;13 &#40;8&#46;71&#41; years since SLE diagnosis was made and 4&#46;61 &#40;2&#46;64&#41; years since onset of belimumab&#46;</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Proteinuria was reduced to normal values in 6 patients&#44; and renal function was stable from the beginning of treatment in all cases&#46; There was a reduction in the anti-DNA level and normalization of complement in those cases in which it was reduced&#46; One patient presented an increase in anti-DNA titer&#44; with normal complement&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">In clinical practice&#44; belimumab can improve LN in terms of serological activity&#44; kidney function and urine sediment&#46;</p></span>"
        "secciones" => array:4 [
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n y objetivo</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Belimumab es un anticuerpo monoclonal aprobado para pacientes con lupus eritematoso sist&#233;mico &#40;LES&#41;&#44; con indicaci&#243;n reciente para nefritis l&#250;pica &#40;NL&#41;&#46;</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">El objetivo es analizar la eficacia de Belimumab en pacientes con NL&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Estudio transversal&#44; retrospectivo&#44; que incluye pacientes diagnosticados de LES &#40;criterios SLICC&#47;ACR 2012&#41;&#44; con nefritis demostrada mediante biopsia&#44; tratados con Belimumab&#46; Se recogieron datos serol&#243;gicos&#44; funci&#243;n renal &#40;creatinina&#44; filtrado glomerular&#41; y sedimento urinario&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Se incluyen 8 pacientes con edad media de 37&#44;56 &#40;7&#44;03&#41; a&#241;os&#44; con 15&#44;13 &#40;8&#44;71&#41; a&#241;os de evoluci&#243;n de la enfermedad y 4&#44;61 &#40;2&#44;64&#41; a&#241;os desde el inicio de belimumab&#46;</p><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">La proteinuria se redujo hasta alcanzar valores normales en 6 pacientes&#44; manteni&#233;ndose la funci&#243;n renal estable desde el inicio del tratamiento en todos los casos&#46; Se registr&#243; una reducci&#243;n del nivel de anti-DNA y una normalizaci&#243;n del complemento en los casos en que estaba reducido&#46; En uno de los pacientes se registr&#243; un aumento del t&#237;tulo de anti-DNA&#44; manteni&#233;ndose el complemento normal&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">En pr&#225;ctica cl&#237;nica real&#44; belimumab puede mejorar la NL en t&#233;rminos de actividad serol&#243;gica&#44; funci&#243;n renal y sedimento urinario&#46;</p></span>"
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          "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Normal levels of anti-DNA&#58; &#60;15<span class="elsevierStyleHsp" style=""></span>IU&#47;mL&#59; C3 normal range&#58; 82&#8722;185<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#59; and C4&#58; 15&#8722;53<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#46;</p>"
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                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Baseline</th><th class="td-with-role" title="\n
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                  \t\t\t\t">0&#46;81&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">80&#44; 20&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">Normal&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">Normal&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">Normal&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">101&#44; 10&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">89&#44; 23&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">50&#44; 15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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