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
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Dermatology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
RMD Open. 2022 Apr;8(1). doi: 10.1136/rmdopen-2021-001669.
To evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) in China.
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.
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%)).
Favourable safety profile and disease control appeared to be maintained in patients with SLE in China for ≤6 years, consistent with previous belimumab studies.
评估贝利尤单抗在中国系统性红斑狼疮（SLE）患者中的长期安全性和疗效。
在这项3期开放标签延长期研究中，符合条件的BEL113750研究（NCT01345253）完成者接受每月静脉注射10 mg/kg贝利尤单抗，持续≤6年。主要终点是安全性。次要终点包括SLE缓解指数（SRI）-4缓解率、严重SLE病情活动和泼尼松使用量的变化。分析基于从首次注射贝利尤单抗直至研究结束的观察数据。
在424例接受贝利尤单抗治疗的患者中，215例（50.7%）完成了研究，208例（49.1%）退出，1例死亡。总体而言，359/424例（84.7%）患者发生了不良事件（AE），96/424例（22.6%）发生了严重AE。26/424例（6.1%）患者因AE停止研究治疗/退出研究。输注后全身反应率为1.5次事件/100患者年。带状疱疹感染率为3.0次事件/100患者年，其中严重事件为0.4次事件/100患者年。分别在第0 - 1年和第3 - 4年报告了1例甲状腺乳头状癌和1例阴道癌。没有完成自杀/自杀未遂事件，也没有严重抑郁的报告。SRI - 4缓解者的比例逐渐增加（第1年，第24周：190/346例（54.9%）；第5年，第48周：6,682例（80.5%））。396例患者中有55例（13.9%）经历了严重病情活动。对于335例基线泼尼松等效剂量>7.5 mg/天的患者，剂量降至≤7.5 mg/天的患者数量随时间增加（第1年，第24周：30/333例（9.0%）；第5年，第48周：36/67例（53.7%））。
在中国SLE患者中，≤6年期间似乎维持了良好的安全性和疾病控制，与之前的贝利尤单抗研究一致。
