接受托法替尼、阿达木单抗或安慰剂治疗的银屑病关节炎患者的临床和患者报告结局的反应时间。
Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo.
机构信息
Department of Medicine, University of Toronto, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada.
University of Oxford, Oxford, UK.
出版信息
Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.
BACKGROUND
This study examined the time to clinically meaningful response in patients with active psoriatic arthritis treated with tofacitinib, adalimumab, or placebo switching to tofacitinib.
METHODS
Data were from two phase 3 studies, OPAL Broaden (12 months) and OPAL Beyond (6 months). Patients received tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks (OPAL Broaden only), or placebo switching to tofacitinib 5 or 10 mg BID at month 3. Baseline to initial response time was according to pre-defined clinically meaningful criteria on Health Assessment Questionnaire-Disability Index (HAQ-DI; ≥ 0.35-point improvement), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; ≥ 4-point improvement), Psoriatic Arthritis Disease Activity Score (PASDAS; post-baseline score ≤ 3.2 and > 1.6-point improvement from baseline), and minimal disease activity (MDA; meeting at least 5 of 7 criteria) composite.
RESULTS
In OPAL Broaden, median time to initial HAQ-DI score response was 29, 53, and 30 days in patients treated with tofacitinib 5 mg BID, tofacitinib 10 mg BID, or adalimumab, compared with 162 and 112 days in patients treated with placebo switching to tofacitinib 5 or 10 mg BID at month 3, respectively. Across studies, median time to initial FACIT-F total score response was shorter in patients receiving tofacitinib 5 mg BID (31 days) vs other groups (84-92 days). Median time to initial response was approximately 11 (MDA)/6-9 months (PASDAS) in tofacitinib/adalimumab groups in OPAL Broaden.
CONCLUSION
This analysis demonstrates tofacitinib's efficacy on most patient-reported and clinical endpoints over time and shows a shorter time to initial, clinically meaningful response in patients receiving tofacitinib vs patients switching from placebo to tofacitinib.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT01877668. Registered June 12, 2013. ClinicalTrials.gov , NCT01882439. Registered June 18, 2013.
背景
本研究旨在观察接受托法替尼、阿达木单抗或安慰剂治疗的活动性银屑病关节炎患者转换为托法替尼后达到临床意义上的应答时间。
方法
数据来自两项 3 期研究，即 OPAL Broaden 研究（12 个月）和 OPAL Beyond 研究（6 个月）。患者在第 3 个月时转换为托法替尼 5 或 10mg 每日 2 次（BID）、阿达木单抗 40mg 每 2 周 1 次（仅 OPAL Broaden 研究）或安慰剂，托法替尼 5 或 10mg BID。根据健康评估问卷残疾指数（HAQ-DI；≥0.35 分的改善）、慢性疾病治疗疲劳量表（FACIT-F；≥4 分的改善）、银屑病关节炎疾病活动评分（PASDAS；与基线相比，后基线评分≤3.2 分且改善≥1.6 分）和最小疾病活动（MDA；满足至少 7 项标准中的 5 项）复合指标，预先定义了临床有意义的应答时间。
结果
在 OPAL Broaden 研究中，接受托法替尼 5mg BID、托法替尼 10mg BID或阿达木单抗治疗的患者达到初始 HAQ-DI 评分应答的中位时间分别为 29、53 和 30 天，而在第 3 个月时转换为托法替尼 5 或 10mg BID 的安慰剂治疗患者分别为 162 和 112 天。在两项研究中，接受托法替尼 5mg BID 治疗的患者达到初始 FACIT-F 总分应答的中位时间较短（31 天），而其他组为 84-92 天。在 OPAL Broaden 研究中，托法替尼/阿达木单抗组患者达到 MDA（11 个月）/PASDAS（6-9 个月）初始应答的中位时间约为 11 个月。
结论
本分析表明，托法替尼在大多数患者报告的和临床终点上的疗效随时间推移而增加，并显示接受托法替尼治疗的患者与从安慰剂转换为托法替尼的患者相比，达到初始临床有意义应答的时间更短。
试验注册
ClinicalTrials.gov，NCT01877668。2013 年 6 月 12 日注册。ClinicalTrials.gov，NCT01882439。2013 年 6 月 18 日注册。
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