Baraliakos Xenofon, Deodhar Atul, van der Heijde Désirée, Van den Bosch Filip, Magrey Marina, Maksymowych Walter P, Tomita Tetsuya, Xu Huji, Massow Ute, Vaux Tom, Prajapati Chetan, Manente Myriam, Marten Alexander, Gensler Lianne S
Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany.
Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.
Rheumatology (Oxford). 2025 Jun 1;64(6):3534-3546. doi: 10.1093/rheumatology/keaf009.
Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, previously demonstrated efficacy and was well tolerated to 1 year in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA). Here, we report bimekizumab safety and efficacy to 2 years.
Patients completing week 52 in the phase 3 studies BE MOBILE 1 (nr-axSpA; NCT03928704) and 2 (r-axSpA; NCT03928743) were eligible for an ongoing open-label extension (OLE; NCT04436640). All OLE patients received subcutaneous bimekizumab 160 mg every 4 weeks. Safety outcomes for patients who received ≥1 bimekizumab dose, and efficacy outcomes for all randomized patients, are reported to week 104.
In the OLE (weeks 52 - 104), 70.8% (367/518) of patients reported ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs [exposure-adjusted incidence rate per 100 patient-years (EAIR/100PY)] were SARS-CoV-2 (COVID-19) infection (25.2), nasopharyngitis (11.0) and oral candidiasis (5.4). Fungal infection EAIR/100PY was 11.8 (majority Candida infections: 6.8; most mild/moderate, none serious/systemic). Inflammatory bowel disease and uveitis rates were low; no major adverse cardiovascular events or deaths occurred. TEAE incidence rate was generally similar across weeks 0 - 52 and 52 - 104.At week 104, >50% of randomized patients (N = 586) achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40); ∼60% achieved Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (<2.1) and >30% achieved ASDAS inactive disease (<1.3). Bimekizumab demonstrated sustained suppression of MRI inflammation at week 104, with >57% of patients achieving MRI remission.
The safety profile of bimekizumab remained consistent with prior reports, with no new safety signals identified. 1-year efficacy was sustained to 2 years across patients with nr-axSpA and r-axSpA.
比美吉珠单抗是一种单克隆IgG1抗体，除抑制IL-17A外还能选择性抑制IL-17F，先前已证明其在非放射学（nr-）和放射学（r-）轴向脊柱关节炎（axSpA）患者中有效且在1年内耐受性良好。在此，我们报告比美吉珠单抗至2年的安全性和疗效。
在3期研究BE MOBILE 1（nr-axSpA；NCT03928704）和2（r-axSpA；NCT03928743）中完成第52周治疗的患者有资格进入正在进行的开放标签扩展研究（OLE；NCT04436640）。所有OLE患者每4周接受一次皮下注射160mg比美吉珠单抗。报告了接受≥1剂比美吉珠单抗患者的安全性结果以及所有随机分组患者至第104周的疗效结果。
在OLE研究（第52 - 104周）中，70.8%（367/518）的患者报告了≥1次治疗中出现的不良事件（TEAE）。最常见的TEAE [每100患者年暴露调整发病率（EAIR/100PY）]为SARS-CoV-2（新冠病毒病）感染（25.2）、鼻咽炎（11.0）和口腔念珠菌病（5.4）。真菌感染的EAIR/100PY为11.8（大多数为念珠菌感染：6.8；大多为轻度/中度，无严重/全身性感染）。炎症性肠病和葡萄膜炎发生率较低；未发生重大不良心血管事件或死亡。TEAE发生率在第0 - 52周和第52 - 104周总体相似。在第104周时，超过50%的随机分组患者（N = 586）达到国际脊柱关节炎协会40%反应评估（ASAS40）；约60%达到轴向脊柱关节炎疾病活动评分（ASDAS）低疾病活动度（<2.1），超过30%达到ASDAS无疾病活动（<1.3）。比美吉珠单抗在第104周时显示出对MRI炎症的持续抑制，超过57%的患者达到MRI缓解。
比美吉珠单抗的安全性与先前报告一致，未发现新的安全信号。nr-axSpA和r-axSpA患者的1年疗效持续至2年。
