Song Gwan Gyu, Lee Young Ho
Int J Clin Pharmacol Ther. 2020 Jun;58(6):293-298. doi: 10.5414/CP203635.
We assessed the relative efficacy and safety of once-daily administration of 100 and 200 mg filgotinib (a JAK1-selective inhibitor) in patients with active rheumatoid arthritis (RA).
We conducted a Bayesian network meta-analysis combining the direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of filgotinib in patients with active RA.
Five RCTs involving 3,920 patients met the inclusion criteria. There were 15 pairwise comparisons, including 8 direct comparisons and 7 interventions. The ACR20 response rate was significantly higher in the filgotinib 200 mg + methotrexate (MTX) group than in the placebo or placebo + MTX group (odds ratio (OR): 12.39, 95% credible interval (CrI): 3.36 - 45.98.10; OR: 2.68, 95% CrI: 1.80 - 4.39). Compared to the placebo group, the filgotinib 100 mg, adalimumab 40 mg + MTX, filgotinib 200 mg, and placebo + MTX groups showed a significantly higher ACR20 response rate. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated filgotinib 200 mg + MTX was likely to achieve the best ACR20 response rate (SUCRA = 0.902), followed by filgotinib 100 mg + MTX (SUCRA = 0.694), filgotinib 100 mg (SUCRA = 0.675), adalimumab 40 mg + MTX (SUCRA = 0.661), filgotinib 200 mg (SUCRA = 0.305), placebo + MTX (SUCRA = 0.259), and placebo (SUCRA = 0.005). The safety based on the number of serious adverse events (SAEs) did not differ significantly among 6 six interventions.
Filgotinib 100 and 200 mg administration once daily in combination with MTX was the most efficacious intervention for active RA, with no significant risk of SAEs.
我们评估了每日一次服用100毫克和200毫克非戈替尼(一种JAK1选择性抑制剂)对活动性类风湿关节炎(RA)患者的相对疗效和安全性。
我们进行了一项贝叶斯网络荟萃分析,结合了来自随机对照试验(RCT)的直接和间接证据,这些试验研究了非戈替尼对活动性RA患者的疗效和安全性。
五项涉及3920名患者的RCT符合纳入标准。有15个成对比较,包括8个直接比较和7种干预措施。非戈替尼200毫克+甲氨蝶呤(MTX)组的美国风湿病学会20%改善标准(ACR20)缓解率显著高于安慰剂组或安慰剂+MTX组(优势比(OR):12.39,95%可信区间(CrI):3.36 - 45.98;OR:2.68,95%CrI:1.80 - 4.39)。与安慰剂组相比,非戈替尼100毫克组、阿达木单抗40毫克+MTX组、非戈替尼200毫克组和安慰剂+MTX组的ACR20缓解率显著更高。基于累积排序曲线下面积(SUCRA)的排序概率表明,非戈替尼200毫克+MTX组最有可能实现最佳ACR20缓解率(SUCRA = 0.902),其次是非戈替尼100毫克+MTX组(SUCRA = 0.694)、非戈替尼100毫克组(SUCRA = 0.675)、阿达木单抗40毫克+MTX组(SUCRA = 0.661)、非戈替尼200毫克组(SUCRA = 0.305)、安慰剂+MTX组(SUCRA = 0.259)和安慰剂组(SUCRA = 0.005)。基于严重不良事件(SAE)数量的安全性在6种干预措施之间没有显著差异。
每日一次服用100毫克和200毫克非戈替尼联合MTX是治疗活动性RA最有效的干预措施,且无显著的SAE风险。