Department of Medicine/Division of Rheumatology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA
Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
RMD Open. 2021 Jan;7(1). doi: 10.1136/rmdopen-2020-001486.
This post-hoc analysis explored the impact of body mass index (BMI) on tofacitinib efficacy/safety in patients with active psoriatic arthritis (PsA).
Data were pooled from two phase 3 studies (NCT01877668; NCT01882439). Analyses included patients randomised to tofacitinib 5/10 mg twio times a day or placebo, stratified by baseline BMI: <25 kg/m, ≥25-<30 kg/m, ≥30-<35 kg/m or ≥35 kg/m. Endpoints (month 3): American College of Rheumatology (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI) and Psoriasis Area and Severity Index (PASI) 75 response rates; dactylitis/enthesitis resolution rates; changes from baseline Short Form-36 Health Survey version 2 (SF-36v2) Physical/Mental Component Summary (PCS) scores and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score. Safety was also reported.
Analysis included 710 patients; 43.8% were obese (BMI ≥30 kg/m). Tofacitinib demonstrated higher efficacy response rates at month 3, compared with placebo, regardless of baseline BMI. Generally, ACR20/50/70 and HAQ-DI response rates, enthesitis resolution rates and changes from baseline in SF-36v2 PCS score and FACIT-F total score (month 3) were reduced in patients with baseline BMI ≥35 kg/m versus patients with lower BMIs. Elevated alanine aminotransferase/aspartate aminotransferase levels were reported in patients with baseline BMI ≥35 kg/m receiving tofacitinib 5 mg but not 10 mg two times a day.
Tofacitinib demonstrated greater efficacy than placebo in patients with PsA, regardless of baseline BMI. For all treatment arms, reduced efficacy was observed in patients with baseline BMI ≥35 kg/m. Safety was generally comparable across BMI categories, although the effect of tofacitinib on liver enzymes in patients with baseline BMI ≥35 kg/m was inconclusive.
本事后分析旨在探讨体重指数（BMI）对托法替布治疗活动性银屑病关节炎（PsA）患者疗效/安全性的影响。
数据来自两项 3 期研究（NCT01877668；NCT01882439）的汇总分析。纳入接受托法替布 5/10mg 每日两次或安慰剂治疗、按基线 BMI 分层的患者：<25kg/m2、≥25-<30kg/m2、≥30-<35kg/m2 或≥35kg/m2。主要终点（第 3 个月）：美国风湿病学会 20/50/70 应答率、健康评估问卷残疾指数（HAQ-DI）和银屑病面积和严重程度指数（PASI）75 应答率、指/趾炎缓解率；自基线变化的简明 36 健康调查量表第 2 版（SF-36v2）物理/精神成分综合评分（PCS）和慢性疾病治疗疲劳量表功能评估（FACIT-F）总分。同时报告安全性。
共纳入 710 例患者；43.8%的患者为肥胖（BMI≥30kg/m2）。与安慰剂相比，托法替布在第 3 个月时疗效应答率更高，与基线 BMI 无关。总体而言，与较低 BMI 患者相比，基线 BMI≥35kg/m2 的患者 ACR20/50/70 和 HAQ-DI 应答率、指/趾炎缓解率以及自基线变化的 SF-36v2 PCS 评分和 FACIT-F 总分（第 3 个月）较低。基线 BMI≥35kg/m2 接受托法替布 5mg 治疗的患者出现丙氨酸氨基转移酶/天门冬氨酸氨基转移酶水平升高，但接受托法替布 10mg 每日两次治疗的患者未见该情况。
托法替布治疗 PsA 患者的疗效优于安慰剂，与基线 BMI 无关。所有治疗组中，基线 BMI≥35kg/m2 的患者疗效均降低。安全性在 BMI 类别之间总体相似，尽管托法替布对基线 BMI≥35kg/m2 患者肝酶的影响尚不确定。
