A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus

• DOI: 10.1177/0961203318777634
• Publication Date: 2018-05-29T06:26:54Z
• Authors: A Doria; D Bass; A Schwarting; A Hammer; D Gordon; M Scheinberg; N L Fox; J Groark; W Stohl; C Kleoudis; D Roth
• Keywords: Belimumab; Tolerability

Objective To evaluate the safety, tolerability and efficacy of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE) beyond 1 year. Methods This was a 24-week, open-label extension following 52-week, double-blind, placebo-controlled trial SC. Patients who completed double-blind phase were eligible to enter phase. All received weekly 200 mg SC plus standard SLE therapy. Outcome measures included safety (SLE Response Index (SRI) Flare (SFI) rates), changes biomarker B cell levels. Results Of 677 phase, 662 entered phase; 206 had previously placebo 456 belimumab. Despite differences total exposure (24 weeks placebo-to-belimumab group versus 76 group), proportions experiencing more than one adverse event (AE) or serious AE similar between groups (placebo-to-belimumab: 51.5 6.8%; belimumab: 48.2 5.5%, respectively). Most AEs mild/moderate severity. Efficacy maintained through An SRI response achieved by 16.1% 76.3% group. Furthermore, 1.0% 2.6% experienced severe SFI flare. Conclusion Belimumab well tolerated during this study. The profile is consistent that previous experience Trial registration ClinicalTrials.gov identifier: NCT01484496