Betts Keith A, Griffith Jenny, Friedman Alan, Zhou Zheng-Yi, Signorovitch James E, Ganguli Arijit
a Analysis Group, Inc. , Los Angeles , CA , USA ;
b AbbVie Inc. , North Chicago , IL , USA ;
Curr Med Res Opin. 2016;32(4):721-9. doi: 10.1185/03007995.2016.1140026. Epub 2016 Jan 25.
Apremilast was recently approved for the treatment of active psoriatic arthritis (PsA). However, no studies compare apremilast with methotrexate or biologic therapies, so its relative comparative efficacy remains unknown. This study compared the response rates and incremental costs per responder associated with methotrexate, apremilast, and biologics for the treatment of active PsA.
A systematic literature review was performed to identify phase 3 randomized controlled clinical trials of approved biologics, methotrexate, and apremilast in the methotrexate-naïve PsA population. Using Bayesian methods, a network meta-analysis was conducted to indirectly compare rates of achieving a ≥20% improvement in American College of Rheumatology component scores (ACR20). The number needed to treat (NNT) and the incremental costs per ACR20 responder (2014 US$) relative to placebo were estimated for each of the therapies.
Three trials (MIPA for methotrexate, PALACE-4 for apremilast, and ADEPT for adalimumab) met all inclusion criteria. The NNTs relative to placebo were 2.63 for adalimumab, 6.69 for apremilast, and 8.31 for methotrexate. Among methotrexate-naïve PsA patients, the 16 week incremental costs per ACR20 responder were $3622 for methotrexate, $26,316 for adalimumab, and $45,808 for apremilast. The incremental costs per ACR20 responder were $222,488 for apremilast vs. methotrexate.
Among methotrexate-naive PsA patients, adalimumab was found to have the lowest NNT for one additional ACR20 response and methotrexate was found to have the lowest incremental costs per ACR20 responder. There was no statistical evidence of greater efficacy for apremilast vs. methotrexate. A head-to-head trial between apremilast and methotrexate is recommended to confirm this finding.
阿普米拉斯最近被批准用于治疗活动性银屑病关节炎(PsA)。然而,尚无研究将阿普米拉斯与甲氨蝶呤或生物疗法进行比较,因此其相对疗效仍不清楚。本研究比较了甲氨蝶呤、阿普米拉斯和生物制剂治疗活动性PsA的缓解率及每位缓解者的增量成本。
进行系统的文献综述,以确定在未使用过甲氨蝶呤的PsA患者群体中,已批准的生物制剂、甲氨蝶呤和阿普米拉斯的3期随机对照临床试验。使用贝叶斯方法进行网络荟萃分析,以间接比较美国风湿病学会组成部分评分(ACR20)改善≥20%的发生率。估计每种疗法相对于安慰剂的治疗所需人数(NNT)和每位ACR20缓解者的增量成本(2014年美元)。
三项试验(甲氨蝶呤的MIPA、阿普米拉斯的PALACE - 4和阿达木单抗的ADEPT)符合所有纳入标准。相对于安慰剂,阿达木单抗的NNT为2.63,阿普米拉斯为6.69,甲氨蝶呤为8.31。在未使用过甲氨蝶呤的PsA患者中,每位ACR20缓解者的16周增量成本分别为:甲氨蝶呤3622美元,阿达木单抗26316美元,阿普米拉斯45808美元。阿普米拉斯相对于甲氨蝶呤,每位ACR20缓解者的增量成本为222488美元。
在未使用过甲氨蝶呤的PsA患者中,发现阿达木单抗使ACR20额外缓解的NNT最低,而甲氨蝶呤每位ACR20缓解者的增量成本最低。没有统计学证据表明阿普米拉斯比甲氨蝶呤疗效更佳。建议进行阿普米拉斯与甲氨蝶呤的直接对比试验以证实这一发现。