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Long‐Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus
Author(s) -
Furie Richard A.,
Wallace Daniel J.,
Aranow Cynthia,
Fettiplace James,
Wilson Barbara,
Mistry Prafull,
Roth David A.,
Gordon David
Publication year - 2018
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.40439
Subject(s) - belimumab , medicine , systemic lupus erythematosus , placebo , prednisone , adverse effect , lupus erythematosus , rheumatology , b cell activating factor , immunology , disease , antibody , pathology , alternative medicine , b cell
Objective We undertook this US multicenter continuation study (GlaxoSmithKline study BEL 112233; ClinicalTrials.gov identifier: NCT 00724867) to assess long‐term safety and efficacy of belimumab in patients with systemic lupus erythematosus ( SLE ) who completed the Study of Belimumab in Subjects with SLE 76‐week trial (ClinicalTrials.gov identifier: NCT 00410384). Methods Patients continued to receive the same belimumab dose plus standard therapy; patients previously receiving placebo received 10 mg/kg belimumab. The primary outcome measure was long‐term safety of belimumab (frequency of adverse events [ AE s] and damage assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [ SDI ], evaluated every 48 weeks [1 study year]). Other assessments included the SLE Responder Index ( SRI ), flare rates (using the modified SLE Flare Index [ SFI ]), prednisone use, and B cell levels. Results Of 268 patients, 140 completed the study and 128 withdrew. The mean ± SD score on the Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index ( SELENA – SLEDAI ) at baseline was 7.8 ± 3.86. The mean ± SD SDI score increased by 0.4 ± 0.68 from its value at baseline (1.2 ± 1.51). The overall incidence of treatment‐related and serious AE s remained stable or declined through study year 7. An SRI response was achieved by 41.9% and 75.6% of patients at the study year 1 and study year 7 midpoints, respectively. At the study year 7 midpoint, relative to baseline, 78.2% had achieved a ≥4‐point reduction in the SELENA – SLEDAI score, 98.4% had no new British Isles Lupus Assessment Group ( BILAG ) A organ domain score and no more than 1 new BILAG B organ domain score, 93.7% had no worsening in the physician's global assessment of disease activity, 20.6% had experienced ≥1 severe SFI flare, the mean decrease in prednisone dose was 31.4%, and the median change in CD 20+ B cell numbers was −83.2%. Conclusion These long‐term exposure results confirm the previously observed safety and efficacy profiles of belimumab in patients with SLE .