Deodhar Atul, Navarro-Compán Victoria, Poddubnyy Denis, Gensler Lianne S, Ramiro Sofia, Tomita Tetsuya, Marzo-Ortega Helena, Fleurinck Carmen, Vaux Thomas, Massow Ute, de Peyrecave Natasha, van der Heijde Désirée, Baraliakos Xenofon
Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, Oregon, USA
Department of Rheumatology, IdiPaz, La Paz University Hospital, Madrid, Spain.
RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081.
Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).
Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. Safety (exposure-adjusted incidence rates/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.
From Weeks 0-256, 289/303 (95.4%) patients had ≥1 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). The EAIR of fungal infections was 7.4 ( infections: 2.6; oral candidiasis: 2.2); none systemic. EAIR of serious infections was 1.4; no active tuberculosis was reported. Active inflammatory bowel disease and anterior uveitis EAIRs were 0.8 and 0.7, respectively. 202/303 (66.7%) patients completed Week 256. 42 (13.9%) patients discontinued treatment due to TEAEs.Efficacy at Week 48 was maintained for 5 years. At Week 256, NRI analysis showed 49.7% (OC: 73.1%) and 41.6% (OC: 71.1%) of patients achieved Assessment of SpondyloArthritis International Society 40% (ASAS40) response and Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity, respectively. Mean (SE; MI) ASDAS improved from 3.9 (0.1) at baseline to 2.1 (0.1) at Week 48, which was maintained to Week 256. Improvements in pain, fatigue, physical function and health-related quality of life were sustained.
The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48.
NCT02963506; NCT03355573.
评估比美吉珠单抗治疗强直性脊柱炎（放射学轴向脊柱关节炎（r-axSpA））的长期安全性、耐受性和疗效。
完成了为期48周剂量范围随机对照试验的活动性r-axSpA患者可进入开放标签扩展试验，患者每4周接受160mg比美吉珠单抗治疗。通过256周展示安全性（暴露调整发病率/100患者年（EAIRs））和疗效结果（二元：无反应者插补（NRI）和观察病例（OC）；连续：多重插补（MI））。
从第0 - 256周，289/303（95.4%）患者发生≥1次治疗中出现的不良事件（TEAE）；最常见的是鼻咽炎（21.8%）和上呼吸道感染（14.5%）。真菌感染的EAIR为7.4（侵袭性感染：2.6；口腔念珠菌病：2.2）；均无全身性感染。严重感染的EAIR为1.4；未报告活动性结核病。活动性炎症性肠病和前葡萄膜炎的EAIR分别为0.8和0.7。202/303（66.7%）患者完成了第256周治疗。42（13.9%）例患者因TEAE停药。第48周的疗效维持了5年。在第256周，NRI分析显示分别有49.7%（OC：73.1%）和41.6%（OC：71.1%）的患者达到国际脊柱关节炎协会40%（ASAS40）反应和轴向脊柱关节炎疾病活动评分（ASDAS）低疾病活动度。平均（SE；MI）ASDAS从基线时的3.9（0.1）改善至第48周时的2.1（0.1），并维持至第256周。疼痛、疲劳、身体功能和健康相关生活质量的改善得以持续。
比美吉珠单抗治疗5年后的安全性概况与既往报告一致，未发现新的安全信号。在第48周实现强有力的疾病控制后，该r-axSpA人群维持了5年的疗效。
NCT02963506；NCT03355573。
