比美吉珠单抗治疗伴或不伴甲氨蝶呤的银屑病关节炎患者的疗效和安全性：两项3期研究的52周结果
Efficacy and Safety of Bimekizumab in Patients With Psoriatic Arthritis With or Without Methotrexate: 52-Week Results From Two Phase 3 Studies.
作者信息
McInnes Iain B, Mease Philip J, Tanaka Yoshiya, Gossec Laure, Husni M Elaine, Kristensen Lars Erik, Warren Richard B, Ink Barbara, Bajracharya Rajan, Coarse Jason, Gottlieb Alice B
机构信息
College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom.
Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle.
出版信息
ACR Open Rheumatol. 2024 Nov;6(11):720-731. doi: 10.1002/acr2.11727. Epub 2024 Jul 30.
OBJECTIVE
The objective of this study was to assess 52-week efficacy and safety of bimekizumab in patients with active psoriatic arthritis (PsA) with or without concomitant methotrexate (+/-MTX) treatment at baseline.
METHODS
We conducted a post hoc analysis of patients in BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve), BE COMPLETE (NCT03896581; prior inadequate response or intolerance to tumor necrosis factor inhibitors [TNFi-IR]), and the BE VITAL open-label extension (NCT04009499) study. Patients were randomized to one of the following treatment groups: bimekizumab 160 mg every four weeks, placebo, or a reference drug (adalimumab 40 mg every two weeks; BE OPTIMAL only). From Week 16, placebo-randomized patients received bimekizumab. Missing data were imputed using non-responder imputation, multiple imputation, or worst-category imputation.
RESULTS
Through Week 52, similar proportions of bimekizumab-treated patients achieved American College of Rheumatology 50% (ACR50) response criteria for both +MTX and -MTX (BE OPTIMAL: 54.4% +MTX, 54.7% -MTX; BE COMPLETE: 56.3% +MTX, 48.0% -MTX). Similar proportions of bimekizumab-treated patients achieved complete skin clearance (Psoriasis Area and Severity Index 100% [PASI100] response) and minimal disease activity in both +MTX and -MTX groups. Similar trends were seen in placebo/bimekizumab-treated patients. Through Week 52, the proportion of bimekizumab-treated patients with ≥1 treatment-emergent adverse event were similar between the +MTX and -MTX groups (BE OPTIMAL 325 of 410 [79.3%] vs 230 of 292 [78.8%], BE COMPLETE 105 of 168 [62.5%] vs 138 of 220 [62.7%]). The safety profile was comparable between subgroups and consistent with the prior safety profile of bimekizumab.
CONCLUSION
Treatment with bimekizumab demonstrated consistent, sustained efficacy to 52 weeks in bDMARD-naïve and TNFi-IR patients with PsA and was well tolerated, irrespective of concomitant MTX.
目的
本研究的目的是评估在基线时接受或未接受甲氨蝶呤（+/-MTX）联合治疗的活动性银屑病关节炎（PsA）患者中，比美吉珠单抗的52周疗效和安全性。
方法
我们对“BE OPTIMAL”（NCT03895203；初治生物改善病情抗风湿药[bDMARD]）、“BE COMPLETE”（NCT03896581；先前对肿瘤坏死因子抑制剂反应不足或不耐受[TNFi-IR]）以及“BE VITAL”开放标签扩展研究（NCT04009499）中的患者进行了事后分析。患者被随机分配到以下治疗组之一：每四周一次的比美吉珠单抗160mg、安慰剂或一种对照药物（仅“BE OPTIMAL”组为每两周一次的阿达木单抗40mg）。从第16周起，接受安慰剂治疗的患者改用比美吉珠单抗。缺失数据采用无反应者插补、多重插补或最差类别插补法进行估算。
结果
至第52周，接受比美吉珠单抗治疗的患者中，无论是否联合MTX，达到美国风湿病学会50%（ACR50）反应标准的比例相似（“BE OPTIMAL”组：联合MTX组为54.4%，未联合MTX组为54.7%；“BE COMPLETE”组：联合MTX组为56.3%，未联合MTX组为48.0%）。在联合MTX和未联合MTX组中，接受比美吉珠单抗治疗的患者达到完全皮肤清除（银屑病面积和严重程度指数100%[PASI100]反应）和最小疾病活动度的比例相似。在接受安慰剂/比美吉珠单抗治疗的患者中也观察到类似趋势。至第52周，联合MTX组和未联合MTX组中发生≥1次治疗中出现的不良事件的比美吉珠单抗治疗患者比例相似（“BE OPTIMAL”组：410例中的325例[79.3%] vs 292例中的230例[78.8%]，“BE COMPLETE”组：168例中的105例[62.5%] vs 220例中的138例[62.7%]）。各亚组之间的安全性特征具有可比性，且与比美吉珠单抗先前的安全性特征一致。
结论
在初治bDMARD和TNFi-IR的PsA患者中，比美吉珠单抗治疗至52周时显示出持续一致的疗效，且无论是否联合MTX，耐受性良好。
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