使用匹配调整间接比较评估52周时比美吉珠单抗和司库奇尤单抗治疗银屑病关节炎患者的疗效比较
Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.
作者信息
Mease Philip J, Warren Richard B, Nash Peter, Grouin Jean-Marie, Lyris Nikos, Willems Damon, Taieb Vanessa, Eells Jason, McInnes Iain B
机构信息
Swedish Medical Center/Providence St. Joseph Health, and University of Washington, Seattle, WA, 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 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
INTRODUCTION
Matching-adjusted indirect comparisons (MAICs) were used to compare the efficacy of bimekizumab and secukinumab 150 mg and 300 mg at 52 weeks for the treatment of psoriatic arthritis (PsA) in patients who were biologic disease-modifying anti-rheumatic drug-naïve (bDMARD-naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
METHODS
Relevant trials were systematically identified. Individual patient data from bimekizumab randomized controlled trials, BE OPTIMAL (N = 431) and BE COMPLETE (N = 267), were matched to aggregate data from bDMARD-naïve and TNFi-IR patient subgroups from FUTURE 2 using secukinumab 150 mg and 300 mg doses (bDMARD-naïve: N = 63/37; TNFi-IR: N = 67/33). To adjust for cross-trial differences, patients from the bimekizumab trials were re-weighted using propensity scores to match the baseline characteristics of patients in the secukinumab trials. Unanchored comparisons of recalculated bimekizumab and secukinumab 52-week non-responder imputation outcomes for 20/50/70% improvement in American College of Rheumatology score (ACR20/50/70) and minimal disease activity (MDA) index were analyzed.
RESULTS
In patients who were bDMARD-naïve, bimekizumab had a greater likelihood of ACR70 response than secukinumab 150 mg (odds ratio [95% confidence interval] 2.39 [1.26, 4.53]; p = 0.008) and secukinumab 300 mg (2.03 [1.11, 3.72]; p = 0.021) at 52 weeks. In patients who were TNFi-IR, bimekizumab had a greater likelihood of response compared to secukinumab 150 mg for ACR20 (3.50 [1.64-7.49]; p = 0.001), ACR50 (3.32 [1.41, 7.80]; p = 0.006), ACR70 (2.95 [1.08, 8.07]; p = 0.035) and MDA (3.52 [1.38, 8.99]; p = 0.009), and a greater likelihood of response compared to secukinumab 300 mg for ACR50 (2.44 [1.06, 5.65]; p = 0.037) and MDA (2.92 [1.20, 7.09]; p = 0.018) at 52 weeks.
CONCLUSION
In this MAIC analysis, the efficacy of bimekizumab, as demonstrated by the likelihood of ACR20/50/70 and MDA response at 52 weeks, was greater or comparable to secukinumab 150 mg and 300 mg for patients with PsA who were bDMARD-naïve and TNFi-IR.
TRIAL REGISTRATION NUMBERS
NCT03895203, NCT03896581, NCT04009499, NCT01752634, NCT01989468, NCT02294227, NCT02404350.
简介
采用匹配调整间接比较（MAIC）方法，比较在52周时，比美吉珠单抗与150毫克和300毫克司库奇尤单抗，用于治疗初治生物性改善病情抗风湿药物（bDMARD）或先前对肿瘤坏死因子抑制剂反应不足或不耐受（TNFi-IR）的银屑病关节炎（PsA）患者的疗效。
方法
系统检索相关试验。将比美吉珠单抗随机对照试验BE OPTIMAL（N = 431）和BE COMPLETE（N = 267）中的个体患者数据，与FUTURE 2中bDMARD初治和TNFi-IR患者亚组使用150毫克和300毫克司库奇尤单抗剂量的汇总数据进行匹配（bDMARD初治：N = 63/37；TNFi-IR：N = 67/33）。为校正试验间差异，对比美吉珠单抗试验中的患者使用倾向评分重新加权，以匹配司库奇尤单抗试验中患者的基线特征。分析重新计算的比美吉珠单抗和司库奇尤单抗52周非应答者推算结局，以评估美国风湿病学会（ACR）20/50/70改善和最小疾病活动度（MDA）指数。
结果
在bDMARD初治患者中，比美吉珠单抗在52周时达到ACR70应答的可能性高于150毫克司库奇尤单抗（比值比[95%置信区间]2.39[1.26，4.53]；p = 0.008）和300毫克司库奇尤单抗（2.03[1.11，3.72]；p = 0.021）。在TNFi-IR患者中，比美吉珠单抗在52周时，ACR20（3.50[1.64 - 7.49]；p = 0.001）、ACR50（3.32[1.41，7.80]；p = 0.006）、ACR70（2.95[1.08，8.07]；p = 0.035）和MDA（3.52[1.38，8.99]；p = 0.009）应答的可能性高于150毫克司库奇尤单抗，ACR50（2.44[1.06，5.65]；p = 0.037）和MDA（2.92[1.20，7.09]；p = 0.018）应答的可能性高于300毫克司库奇尤单抗。
结论
在这项MAIC分析中，对于bDMARD初治和TNFi-IR的PsA患者，比美吉珠单抗在52周时的ACR20/50/70和MDA应答可能性所显示的疗效，优于或等同于150毫克和300毫克司库奇尤单抗。
试验注册号
NCT03895203、NCT03896581、NCT04009499、NCT01752634、NCT01989468、NCT02294227、NCT02404350。
Zotero 插件