| Title | 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 |
| Authors | Zhang, Fengchun Zheng, Jie Li, Yang Wang, Guochun Wang, Mingjun Su, Yin Gu, Jieruo Li, Xingfu Bass, Damon Chu, Myron Curtis, Paula DeRose, Kathleen Kurrasch, Regina Lowe, Jenny Meizlik, Paige Roth, David A. |
| Affiliation | Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Rheumatol & Clin Immunol, Beijing, Peoples R China Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Dermatol, Shanghai, Peoples R China Harbin Med Univ, Affiliated Hosp 2, Dept Rheumatol, Harbin, Peoples R China China Japan Friendship Hosp, Dept Rheumatol, Beijing, Peoples R China Soochow Univ, Dept Rheumatol, Affiliated Hosp 1, Suzhou, Peoples R China Peking Univ, Dept Rheumatol & Immunol, Peoples Hosp, Beijing, Peoples R China Sun Yat Sen Univ, Dept Rheumatol & Immunol, Affiliated Hosp 3, Guangzhou, Guangdong, Peoples R China Shandong Univ, Dept Rheumatol, Qilu Hosp, Jinan, Peoples R China GlaxoSmithKline, Immunoinflammat, Collegeville, PA 19426 USA GlaxoSmithKline, Biostat, Brentford, Middx, England GlaxoSmithKline, Immunoinflammat & Fibrosis, Brentford, Middx, England |
| Keywords | B-LYMPHOCYTE STIMULATOR MONOCLONAL-ANTIBODY |
| Issue Date | Apr-2022 |
| Publisher | RMD OPEN |
| Abstract | 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. |
| URI | http://hdl.handle.net/20.500.11897/642366 |
| ISSN | 2056-5933 |
| DOI | 10.1136/rmdopen-2021-001669 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 |
