Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.
University of Glasgow, Glasgow, UK.
Arthritis Rheumatol. 2022 Dec;74(12):1959-1970. doi: 10.1002/art.42280. Epub 2022 Nov 18.
To assess the long-term safety, tolerability, and efficacy of bimekizumab in active psoriatic arthritis (PsA).
Adult patients with active PsA who completed the double- and dose-blind periods of the BE ACTIVE randomized controlled trial were eligible to enroll in the open-label extension (OLE) study at week 48, after which patients received 160 mg of bimekizumab every 4 weeks. Safety and efficacy results are presented through 152 weeks.
At week 152, 161 of 206 patients (78.2%) remained in the study. From weeks 0-152, 184 of 206 patients experienced ≥1 treatment-emergent adverse event (126.4 per 100 patient-years). The most frequent events were nasopharyngitis (7.6 per 100 patient-years), upper respiratory tract infection (6.8 per 100 patient-years), bronchitis (3.5 per 100 patient-years), and oral candidiasis (3.5 per 100 patient-years). Additionally, 47 of 206 patients had mild to moderate localized fungal infections (9.7 per 100 patient-years), including 24 of 206 patients who had Candida infections (4.6 per 100 patient years) and 19 of 206 patients who had oral candidiasis (3.5 per 100 patient years). Four patients had serious infections (0.7 per 100 patient-years); there were no reported cases of active tuberculosis, adjudicated major adverse cardiac events, or deaths. Efficacy demonstrated at week 48 was sustained in the OLE study. At week 152, nonresponder imputation analysis showed that 52.9% of patients (69.4% of observed cases) achieved the American College of Rheumatology criteria for 50% improvement, 57.7% (73.8% of observed cases) achieved 100% skin clearance per the Psoriasis Area and Severity Index, and 51.5% (67.5% of observed cases) achieved minimal disease activity. Patients also maintained improvements in pain, physical function, and health-related quality of life.
The safety profile of bimekizumab was consistent with previous reports, with no new safety signals identified. Sustained joint and efficacy responses were observed over 3 years.
评估比美吉珠单抗治疗活跃型银屑病关节炎（PsA）的长期安全性、耐受性和疗效。
完成双盲和剂量盲的 BE ACTIVE 随机对照试验的活跃型 PsA 成年患者，在第 48 周有资格进入开放标签扩展（OLE）研究，之后患者每 4 周接受 160mg 比美吉珠单抗治疗。安全性和疗效结果报告至 152 周。
在第 152 周，206 例患者中有 161 例（78.2%）仍在研究中。从第 0 周到第 152 周，206 例患者中有 184 例（126.4 例/100 患者年）发生了≥1 次治疗后出现的不良事件。最常见的事件是鼻咽炎（7.6 例/100 患者年）、上呼吸道感染（6.8 例/100 患者年）、支气管炎（3.5 例/100 患者年）和口腔念珠菌病（3.5 例/100 患者年）。此外，206 例患者中有 47 例（9.7 例/100 患者年）发生了轻度至中度局部真菌感染，包括 24 例（4.6 例/100 患者年）患者发生了念珠菌感染，19 例（3.5 例/100 患者年）患者发生了口腔念珠菌病。有 4 例发生严重感染（0.7 例/100 患者年）；没有报告活动性结核病、判定的主要不良心脏事件或死亡病例。OLE 研究中，第 48 周时观察到的疗效持续至第 152 周。在第 152 周，非应答者推断分析显示，52.9%（69.4%的观察病例）的患者达到美国风湿病学会 50%缓解标准，57.7%（73.8%的观察病例）达到银屑病面积和严重程度指数 100%皮肤清除率，51.5%（67.5%的观察病例）达到最小疾病活动度。患者的疼痛、身体功能和健康相关生活质量也持续得到改善。
比美吉珠单抗的安全性与既往报告一致，未发现新的安全性信号。3 年多来持续观察到关节和疗效应答。
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