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
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.
ACR Open Rheumatol. 2024 Nov;6(11):720-731. doi: 10.1002/acr2.11727. Epub 2024 Jul 30.
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.
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.
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.
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.
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。
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。
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。
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。
