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Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials

Identifieur interne : 000493 ( Canada/Analysis ); précédent : 000492; suivant : 000494

Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials

Auteurs : Susan Manzi [États-Unis] ; Jorge Sánchez-Guerrero [Mexique] ; Joan T. Merrill [États-Unis] ; Richard Furie [États-Unis] ; Dafna Gladman [Canada] ; Sandra V. Navarra [Philippines] ; Ellen M. Ginzler [États-Unis] ; David P. D'Cruz [Royaume-Uni] ; Andrea Doria [Italie] ; Simon Cooper [États-Unis] ; Z John Zhong [États-Unis] ; Douglas Hough [États-Unis] ; William Freimuth [États-Unis] ; Michelle A. Petri [États-Unis]

Source :

RBID : ISTEX:0944527FEB9B49F85DEDD372DFE3B676C0CB1C22

Descripteurs français

English descriptors

Abstract

Objective To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity. Methods Data obtained after 52 weeks of treatment from two phase III trials (BLISS-52 and BLISS-76) comparing belimumab 1 and 10 mg/kg versus placebo, plus standard therapy, in 1684 autoantibody-positive patients were analysed post hoc for changes in British Isles Lupus Assessment Group (BILAG) and Safety of Estrogens in Lupus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA–SLEDAI) organ domain scores. Results At baseline, the domains involved in the majority of patients were musculoskeletal and mucocutaneous by both BILAG and SELENA–SLEDAI, and immunological by SELENA–SLEDAI. At 52 weeks, significantly more patients treated with belimumab versus placebo had improvement in BILAG musculoskeletal and mucocutaneous domains (1 and 10 mg/kg), and in SELENA–SLEDAI mucocutaneous (10 mg/kg), musculoskeletal (1 mg/kg) and immunological (1 and 10 mg/kg) domains. Improvement was also observed in other organ systems with a low prevalence (≤16%) at baseline, including the SELENA–SLEDAI vasculitis and central nervous system domains. Significantly fewer patients treated with belimumab versus placebo had worsening in the BILAG haematological domain (1 mg/kg) and in the SELENA–SLEDAI immunological (10 mg/kg), haematological (10 mg/kg) and renal (1 mg/kg) domains. Conclusions Belimumab treatment improved overall SLE disease activity in the most common musculoskeletal and mucocutaneous organ domains. Less worsening occurred in the haematological, immunological and renal domains.

Url:
DOI: 10.1136/annrheumdis-2011-200831


Affiliations:


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ISTEX:0944527FEB9B49F85DEDD372DFE3B676C0CB1C22

Le document en format XML

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<term>Activity index</term>
<term>Arthritis rheum</term>
<term>B-Lymphocyte</term>
<term>Baseline</term>
<term>Belimumab</term>
<term>Belimumab groups</term>
<term>Belimumab treatment</term>
<term>Bilag</term>
<term>Board membership</term>
<term>British isles lupus assessment group</term>
<term>Chemotherapy</term>
<term>Consulting fees</term>
<term>Data acquisition</term>
<term>Disease activity</term>
<term>Disease characteristics</term>
<term>Domain</term>
<term>Domain score</term>
<term>Epidemiological research</term>
<term>Erythematosus</term>
<term>Fewer patients</term>
<term>Grant support</term>
<term>Gure</term>
<term>Haematological</term>
<term>Human</term>
<term>Immunological</term>
<term>Immunological domain</term>
<term>Immunomodulator</term>
<term>Improvement rates</term>
<term>Lupus</term>
<term>Lupus erythematosus disease activity index</term>
<term>Lymphocyte</term>
<term>Lymphocyte stimulator</term>
<term>More organ systems</term>
<term>More patients</term>
<term>Mucocutaneous</term>
<term>Multiple</term>
<term>Musculoskeletal</term>
<term>Musculoskeletal domain</term>
<term>Organ</term>
<term>Organ domain involvement</term>
<term>Organ domain scores</term>
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<term>Organ systems</term>
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<term>Response rates</term>
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<term>Immunomodulateur</term>
<term>Indice d'activité</term>
<term>Lupus érythémateux disséminé</term>
<term>Lymphocyte B</term>
<term>Multiple</term>
<term>Organe</term>
<term>Rhumatologie</term>
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<keywords scheme="Teeft" xml:lang="en">
<term>Arthritis rheum</term>
<term>Baseline</term>
<term>Belimumab</term>
<term>Belimumab groups</term>
<term>Belimumab treatment</term>
<term>Bilag</term>
<term>Board membership</term>
<term>British isles lupus assessment group</term>
<term>Consulting fees</term>
<term>Data acquisition</term>
<term>Disease activity</term>
<term>Disease characteristics</term>
<term>Domain</term>
<term>Domain score</term>
<term>Epidemiological research</term>
<term>Erythematosus</term>
<term>Fewer patients</term>
<term>Grant support</term>
<term>Gure</term>
<term>Haematological</term>
<term>Immunological</term>
<term>Immunological domain</term>
<term>Improvement rates</term>
<term>Lupus</term>
<term>Lupus erythematosus disease activity index</term>
<term>Lymphocyte</term>
<term>Lymphocyte stimulator</term>
<term>More organ systems</term>
<term>More patients</term>
<term>Mucocutaneous</term>
<term>Musculoskeletal</term>
<term>Musculoskeletal domain</term>
<term>Organ</term>
<term>Organ domain involvement</term>
<term>Organ domain scores</term>
<term>Organ domains</term>
<term>Organ systems</term>
<term>Placebo</term>
<term>Primary endpoint</term>
<term>Renal</term>
<term>Response rates</term>
<term>Rheum</term>
<term>Standard therapy</term>
<term>Systemic lupus erythematosus</term>
<term>Treatment effect</term>
<term>Treatment groups</term>
<term>Vasculitis</term>
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<div type="abstract">Objective To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity. Methods Data obtained after 52 weeks of treatment from two phase III trials (BLISS-52 and BLISS-76) comparing belimumab 1 and 10 mg/kg versus placebo, plus standard therapy, in 1684 autoantibody-positive patients were analysed post hoc for changes in British Isles Lupus Assessment Group (BILAG) and Safety of Estrogens in Lupus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA–SLEDAI) organ domain scores. Results At baseline, the domains involved in the majority of patients were musculoskeletal and mucocutaneous by both BILAG and SELENA–SLEDAI, and immunological by SELENA–SLEDAI. At 52 weeks, significantly more patients treated with belimumab versus placebo had improvement in BILAG musculoskeletal and mucocutaneous domains (1 and 10 mg/kg), and in SELENA–SLEDAI mucocutaneous (10 mg/kg), musculoskeletal (1 mg/kg) and immunological (1 and 10 mg/kg) domains. Improvement was also observed in other organ systems with a low prevalence (≤16%) at baseline, including the SELENA–SLEDAI vasculitis and central nervous system domains. Significantly fewer patients treated with belimumab versus placebo had worsening in the BILAG haematological domain (1 mg/kg) and in the SELENA–SLEDAI immunological (10 mg/kg), haematological (10 mg/kg) and renal (1 mg/kg) domains. Conclusions Belimumab treatment improved overall SLE disease activity in the most common musculoskeletal and mucocutaneous organ domains. Less worsening occurred in the haematological, immunological and renal domains.</div>
</front>
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Data generation: Fri Jun 18 17:37:45 2021. Site generation: Fri Jun 18 18:15:47 2021