Efficacy and Safety of Subcutaneous Belimumab in Anti\u2013Double-Stranded DNA\u2013Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus
- Doria, A.
- Stohl, W.
- Schwarting, A.
- Okada, M.
- Scheinberg, M.
- van Vollenhoven, R.
- Hammer, A. E.
- Groark, J.
- Bass, D.
- Fox, N. L.
- Roth, D.
- Gordon, D.
DOIAbstract
OBJECTIVE. To investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in a subset of patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 <90 mg/dl and/or C4 <10 mg/dl) and anti-double-stranded DNA (anti-dsDNA) positive ( 6530 IU/ml) at baseline. METHODS: In this phase III, double-blind, placebo-controlled study (BEL112341; ClinicalTrials.gov identifier: NCT01484496), patients with moderate to severe SLE (Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index [SELENA-SLEDAI] score 658) were randomized (2:1) to receive weekly subcutaneous (SC) belimumab 200 mg or placebo...
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