使用匹配调整间接比较评估的52周时比美吉珠单抗和优特克单抗治疗银屑病关节炎患者的疗效比较
Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.
作者信息
Mease Philip J, Warren Richard B, Nash Peter, Grouin Jean-Marie, Lyris Nikos, Taieb Vanessa, Eells Jason, McInnes Iain B
机构信息
Swedish Medical Center/Providence St. Joseph Health and University of Washington, 601 Broadway, Seattle, WA, 98122, USA.
Dermatology Centre, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, UK.
出版信息
Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.
INTRODUCTION
A matching-adjusted indirect comparison (MAIC) was conducted to assess the relative efficacy at 52 weeks (Wk52) of bimekizumab 160 mg every 4 weeks (Q4W) and ustekinumab 45 or 90 mg every 12 weeks (Q12W) in patients with psoriatic arthritis (PsA) who were biologic disease-modifying anti-rheumatic drug naïve (bDMARD naïve) or who had a previous inadequate response or an intolerance to tumor necrosis factor inhibitors (TNFi-IR).
METHODS
Relevant trials were systematically identified. Individual patient data from the bimekizumab trials BE OPTIMAL (NCT03895203; N = 431) and BE COMPLETE (NCT03896581; N = 267) were matched with summary data on patients receiving ustekinumab in the PSUMMIT 1 trial (NCT01009086; 45 mg, N = 205; 90 mg; N = 204) and a subgroup of TNFi-IR patients receiving ustekinumab in the PSUMMIT 2 trial (NCT01077362; 45 mg, N = 60; 90 mg, N = 58), respectively. Patients from the bimekizumab trials were re-weighted using propensity scores to match the baseline characteristics of the ustekinumab trial patients. Adjustment variables were selected based on expert consensus (n = 5) and adherence to established MAIC guidelines. Non-placebo-adjusted comparisons of recalculated bimekizumab and ustekinumab outcomes for the American College of Rheumatology (ACR) 20/50/70 response criteria (non-responder imputation) were analyzed.
RESULTS
In patients who were bDMARD naïve, bimekizumab had a greater likelihood of response than ustekinumab at Wk52 for ACR20 (odds ratio [95% confidence interval] 45 mg: 2.14 [1.35, 3.40]; 90 mg: 1.98 [1.24, 3.16]), ACR50 (45 mg: 2.74 [1.75, 4.29]; 90 mg: 2.29 [1.48, 3.55]), and ACR70 (45 mg: 3.33 [2.04, 5.46]; 90 mg: 3.05 [1.89, 4.91]). In patients who were TNFi-IR, bimekizumab had a greater likelihood of response than ustekinumab at Wk52 for ACR20 (45 mg: 4.17 [2.13, 8.16]; 90 mg: 4.19 [2.07, 8.49]), ACR50 (45 mg: 5.00 [2.26, 11.05]; 90 mg: 3.86 [1.70, 8.79]), and ACR70 (45 mg: 9.85 [2.79, 34.79]; 90 mg: 6.29 [1.98, 20.04]).
CONCLUSIONS
Using MAIC, bimekizumab showed greater efficacy than ustekinumab in achieving all ACR responses in patients with PsA who were bDMARD naïve and TNFi-IR at Wk52.
TRIAL REGISTRATION
NCT03895203, NCT03896581, NCT01009086, NCT01077362.
简介
进行了一项匹配调整间接比较（MAIC），以评估每4周一次皮下注射160mg比美吉珠单抗（bimekizumab）与每12周一次皮下注射45mg或90mg优特克单抗（ustekinumab）在未使用过生物改善病情抗风湿药（bDMARD）或既往对肿瘤坏死因子抑制剂治疗反应不足或不耐受（TNFi-IR）的银屑病关节炎（PsA）患者中，52周（Wk52）时的相对疗效。
方法
系统检索相关试验。来自比美吉珠单抗试验BE OPTIMAL（NCT03895203；N = 431）和BE COMPLETE（NCT03896581；N = 267）的个体患者数据，分别与PSUMMIT 1试验（NCT01009086；45mg，N = 205；90mg，N = 204）中接受优特克单抗治疗的患者汇总数据，以及PSUMMIT 2试验（NCT01077362；45mg，N = 60；90mg，N = 58）中接受优特克单抗治疗的TNFi-IR患者亚组数据进行匹配。使用倾向评分对来自比美吉珠单抗试验的患者进行重新加权，以匹配优特克单抗试验患者的基线特征。根据专家共识（n = 5）和遵循既定的MAIC指南选择调整变量。对重新计算的比美吉珠单抗和优特克单抗治疗结果进行非安慰剂调整的比较，以评估美国风湿病学会（ACR）20/50/70反应标准（无反应者插补）。
结果
在未使用过bDMARD的患者中，在Wk52时，比美吉珠单抗达到ACR20（优势比[95%置信区间]，45mg：2.14[1.35，3.40]；90mg：1.98[1.24，3.16]）、ACR50（45mg：2.74[1.75，4.29]；90mg：2.29[1.48，3.55]）和ACR70（45mg：3.33[2.04，5.46]；90mg：3.05[1.89，4.91]）反应的可能性高于优特克单抗。在TNFi-IR患者中，在Wk52时，比美吉珠单抗达到ACR20（45mg：4.17[2.13，8.16]；90mg：4.19[2.07，8.49]）、ACR50（45mg：5.00[2.26，11.05]；90mg：3.86[1.70，8.79]）和ACR70（45mg：9.85[2.79，34.79]；90mg：6.29[1.98，20.04]）反应的可能性高于优特克单抗。
结论
使用MAIC，比美吉珠单抗在Wk52时，在未使用过bDMARD和TNFi-IR的PsA患者中，在实现所有ACR反应方面显示出比优特克单抗更高的疗效。
试验注册
NCT03895203、NCT03896581、NCT01009086、NCT01077362 。
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