Journal Article

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

Furie, Richard, Navarra, Sandra V, Sánchez-Guerrero, Jorge, Hough, Douglas, Ginzler, Ellen M, Gladman, Dafna, Merrill, Joan T, Zhong, Z John, Manzi, Susan, Doria, Andrea, Cooper, Simon, Freimuth, William, D'Cruz, David P, Petri, Michelle A

2012

Overview

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.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,BMJ Publishing Group,Elsevier Limited,BMJ Group
• Subject: Adult / Antibodies, Monoclonal - therapeutic use / Antibodies, Monoclonal, Humanized / B-Cell Activating Factor - antagonists & inhibitors / B-Cell Activating Factor - drug effects / Biological and medical sciences / Clinical and Epidemiological Research / Design / Diseases of the osteoarticular system / Double-Blind Method / Female / Health risk assessment / Health Status / Humans / Immunology / Immunomodulators / Lupus / Lupus Erythematosus, Systemic - drug therapy / Lupus Erythematosus, Systemic - immunology / Lupus Erythematosus, Systemic - pathology / Lymphocytes / Male / Medical sciences / Mortality / Multivariate analysis / Pharmacology. Drug treatments / Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis / Severity of Illness Index / Studies / Treatment Outcome