bimekizumab治疗成人轴性脊柱炎或银屑病关节炎的长期安全性:来自IIb/III期综合临床研究的汇总结果

IF 5.1 2区 医学 Q1 RHEUMATOLOGY
Philip J Mease, Lianne S Gensler, Ana-Maria Orbai, Richard B Warren, Rajan Bajracharya, Barbara Ink, Alexander Marten, Ute Massow, Vishvesh Shende, Myriam Manente, Luke Peterson, Katy White, Robert Landewé, Denis Poddubnyy
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引用次数: 0

摘要

目的:评估bimekizumab (BKZ)治疗轴性脊柱炎(axSpA)和银屑病关节炎(PsA)患者的长期安全性。方法:报告了每4周接受≥1剂量BKZ 160 mg的患者的axSpA和PsA的6项IIb/III期综合研究的安全性数据(截至2022年7月III期数据cut)。治疗中出现的不良事件(teae)使用暴露调整后的发病率每100患者年(EAIR/100 PY)进行报告。结果:axSpA和PsA安全池分别包括848例(总BKZ暴露量:2034.4 PY)和1407例(2590.8 PY)患者。在EAIR/100 PY中,axSpA为136.9,PsA为139.6;teae导致的研究中止率较低(axSpA: 2.7/100 PY;PsA: 3.1/100 PY)。最常报告的三种teae是SARS-CoV-2 (COVID-19)感染(axSpA: 7.8/100 PY;PsA: 8.8/100 PY),鼻咽炎(axSpA: 8.2/100 PY;PsA: 7.7/100 PY)和上呼吸道感染(axSpA: 5.0/100 PY;PsA: 5.6/100 PY)。口腔念珠菌病的EAIR/100 PY在axSpA组为3.7,在PsA组为4.2;大多数事件是轻度/中度的。因口腔念珠菌病停药的EAIR较低(axSpA和PsA均为0.3/100 PY)。无系统性真菌感染或活动性肺结核病例报告。确诊的明确/可能的炎症性肠病、葡萄膜炎、确诊的主要不良心血管事件和确诊的自杀意念/行为的发生率较低。结论:总体而言,BKZ表现出良好的耐受性,在axSpA和PsA队列中TEAE EAIRs相当,在延长的治疗期间保持稳定。没有发现新的安全信号。试验注册号:NCT02963506 (BE AGILE);Nct03355573(敏捷2);Nct03928704(手机1);Nct03928743(手机2);Nct04436640(移动);Nct02969525(激活);Nct03347110(被激活2);Nct03895203(最佳);Nct03896581(已完成);Nct04009499(至关重要)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies.

Objective: To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).

Methods: Safety data pooled from six integrated phase IIb/III studies in axSpA and PsA are reported (to the July 2022 data-cut for phase III) for patients who received ≥1 dose of BKZ 160 mg every 4 weeks. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rate per 100 patient-years (EAIR/100 PY).

Results: The axSpA and PsA safety pools included 848 (total BKZ exposure: 2034.4 PY) and 1407 patients (2590.8 PY), respectively. TEAEs occurred at an EAIR/100 PY of 136.9 in axSpA and 139.6 in PsA; study discontinuation due to TEAEs was low (axSpA: 2.7/100 PY; PsA: 3.1/100 PY). The three most frequently reported TEAEs were SARS-CoV-2 (COVID-19) infection (axSpA: 7.8/100 PY; PsA: 8.8/100 PY), nasopharyngitis (axSpA: 8.2/100 PY; PsA: 7.7/100 PY) and upper respiratory tract infection (axSpA: 5.0/100 PY; PsA: 5.6/100 PY). EAIR/100 PY of oral candidiasis was 3.7 in axSpA and 4.2 in PsA; most events were mild/moderate. EAIR of BKZ discontinuation due to oral candidiasis was low (both axSpA and PsA: 0.3/100 PY). No systemic fungal infections or cases of active tuberculosis were reported. EAIRs of adjudicated definite/probable inflammatory bowel disease, uveitis, adjudicated major adverse cardiovascular events and adjudicated suicidal ideation/behaviour were low.

Conclusion: Overall, BKZ demonstrated good tolerability, with TEAE EAIRs comparable between axSpA and PsA cohorts, remaining stable over extended treatment periods. No new safety signals were identified.

Trial registration numbers: NCT02963506 (BE AGILE); NCT03355573 (BE AGILE 2); NCT03928704 (BE MOBILE 1); NCT03928743 (BE MOBILE 2); NCT04436640 (BE MOVING); NCT02969525 (BE ACTIVE); NCT03347110 (BE ACTIVE 2); NCT03895203 (BE OPTIMAL); NCT03896581 (BE COMPLETE); NCT04009499 (BE VITAL).

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来源期刊
RMD Open
RMD Open RHEUMATOLOGY-
CiteScore
7.30
自引率
6.50%
发文量
205
审稿时长
14 weeks
期刊介绍: RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.
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