TY - JOUR T1 - 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. AU - Manzi,Susan, AU - Sánchez-Guerrero,Jorge, AU - Merrill,Joan T, AU - Furie,Richard, AU - Gladman,Dafna, AU - Navarra,Sandra V, AU - Ginzler,Ellen M, AU - D'Cruz,David P, AU - Doria,Andrea, AU - Cooper,Simon, AU - Zhong,Z John, AU - Hough,Douglas, AU - Freimuth,William, AU - Petri,Michelle A, AU - ,, Y1 - 2012/05/01/ PY - 2012/5/3/entrez PY - 2012/5/3/pubmed PY - 2012/12/21/medline SP - 1833 EP - 8 JF - Annals of the rheumatic diseases JO - Ann. Rheum. Dis. VL - 71 IS - 11 N2 - 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. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/22550315/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_ L2 - http://ard.bmj.com/cgi/pmidlookup?view=long&pmid=22550315 DB - PRIME DP - Unbound Medicine ER -