背景:进行了匹配调整的间接比较(MAIC),以评估每4周(Q4W)160mg比马单抗和每12周(Q12W)45或90mgustekinumab的52周(Wk52)对银屑病关节炎(PsA)患者的相对疗效,这些患者是生物学疾病改善的抗风湿坏死药物初发(bnaDMARD)或对先前
方法:系统确定了相关试验。来自bimekizumab试验BEOPTIMAL(NCT03895203;N=431)和BECOMPLETE(NCT03896581;N=267)的个体患者数据与PSUMMIT1试验中接受ustekinumab的患者的汇总数据(NCT01009086;45mg,N=205;90mg;N=204)和在PSummit2试验中接受ustekinumab的TNFi-IR患者亚组(NCT01077362;45mg,N=60;90mg,N=58),分别。使用倾向评分重新加权来自bimekizumab试验的患者,以匹配ustekinumab试验患者的基线特征。根据专家共识(n=5)和对已建立的MAIC指南的遵守情况选择调整变量。分析了美国风湿病学会(ACR)20/50/70反应标准(无反应者归因)的重新计算的bimekizumab和ustekinumab结果的非安慰剂校正比较。
结果:在bDMARD幼稚的患者中,Bimekizumab在Wk52对ACR20的反应可能性大于ustekinumab(比值比[95%置信区间]45mg:2.14[1.35,3.40];90mg:1.98[1.24,3.16]),ACR50(45毫克:2.74[1.75,4.29];90毫克:2.29[1.48,3.55]),和ACR70(45mg:3.33[2.04,5.46];90mg:3.05[1.89,4.91])。在TNFi-IR患者中,Bimekizumab在Wk52对ACR20的反应可能性大于ustekinumab(45mg:4.17[2.13,8.16];90mg:4.19[2.07,8.49]),ACR50(45毫克:5.00[2.26,11.05];90毫克:3.86[1.70,8.79]),和ACR70(45mg:9.85[2.79,34.79];90mg:6.29[1.98,20.04])。
结论:使用MAIC,bimekizumab在实现PsA患者的所有ACR反应方面显示出比ustekinumab更高的疗效,PsA患者在Wk52为bDMARD初始和TNFi-IR。
背景:NCT03895203,NCT03896581,NCT01009086,NCT01077362。
BACKGROUND: 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.
BACKGROUND: NCT03895203, NCT03896581, NCT01009086, NCT01077362.