TY - JOUR T1 - Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2021-001669 VL - 8 IS - 1 SP - e001669 AU - Fengchun Zhang AU - Jie Zheng AU - Yang Li AU - Guochun Wang AU - Mingjun Wang AU - Yin Su AU - Jieruo Gu AU - Xingfu Li AU - Damon Bass AU - Myron Chu AU - Paula Curtis AU - Kathleen DeRose AU - Regina Kurrasch AU - Jenny Lowe AU - Paige Meizlik AU - David A Roth Y1 - 2022/04/01 UR - http://rmdopen.bmj.com/content/8/1/e001669.abstract N2 - Objectives To evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) in China.Methods In this phase 3, open-label extension period, eligible completers of study BEL113750 (NCT01345253) received intravenous belimumab 10 mg/kg monthly for ≤6 years. The primary endpoint was safety. Secondary endpoints included the SLE Responder Index (SRI)-4 response rate, severe SLE flares and changes in prednisone use. Analyses were based on observed data from the first dose of belimumab through to study end.Results Of the 424 patients who received belimumab, 215 (50.7%) completed the study, 208 (49.1%) withdrew and 1 patient died. Overall, 359/424 (84.7%) patients had adverse events (AEs), and 96/424 (22.6%) had serious AEs. 26/424 (6.1%) patients discontinued study treatment/withdrew from the study due to AEs. Postinfusion systemic reaction rate was 1.5 events/100 patient-years. Herpes zoster infection rate was 3.0 events/100 patient-years, of which 0.4 events/100 patient-years were serious events. One papillary thyroid cancer and one vaginal cancer were reported in year 0–1 and year 3–4, respectively. There were no completed suicides/suicide attempts and no reports of serious depression. The proportion of SRI-4 responders increased progressively (year 1, week 24: 190/346 (54.9%); year 5, week 48: 66/82 (80.5%)). Severe flares were experienced by 55/396 (13.9%) patients. For 335 patients with baseline prednisone-equivalent dose >7.5 mg/day, the number of patients with a dose reduction to ≤7.5 mg/day increased over time (year 1, week 24: 30/333 (9.0%); year 5, week 48: 36/67 (53.7%)).Conclusions Favourable safety profile and disease control appeared to be maintained in patients with SLE in China for ≤6 years, consistent with previous belimumab studies.Data are available upon reasonable request. Anonymised individual patient data and study documents can be requested for further research from: https://www.clinicalstudydatarequest.com/. ER -