In previous clinical trials, patients with active rheumatoid arthritis (RA) treated with upadacitinib (UPA) have improved patient-reported outcomes (PROs). This post hoc analysis of SELECT-CHOICE, a phase 3 clinical trial, evaluated the impact of UPA vs abatacept (ABA) with background conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on PROs in patients with RA with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR). Patients in SELECT-CHOICE received UPA (oral 15 mg/day) or ABA (intravenous). PROs evaluated included Patient Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), patient’s assessment of pain by VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), morning stiffness duration and severity, 36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Impairment (WPAI), and EQ-5D 5-Level (EQ-5D-5L) index score. Least squares mean (LSM) changes from baseline to weeks 12 and 24 were based on an analysis of covariance model. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) were compared using chi-square tests. Data from 612 patients were analyzed (UPA, n=303; ABA, n=309). Mean age was 56 years and mean disease duration was 12 years. One-third received ≥2 prior bDMARDs and 72% received concomitant methotrexate at baseline. At week 12, UPA- vs ABA-treated patients had significantly greater improvements in PtGA, pain, HAQ-DI, morning stiffness severity, EQ-5D-5L, 2/4 WPAI domains, and 3/8 SF-36 domains and Physical Component Summary (PCS) scores (P<0.05); significant differences persisted at week 24 for HAQ-DI, morning stiffness severity, SF-36 PCS and bodily pain domain, and WPAI activity impairment domain. At week 12, significantly more UPA- vs ABA-treated patients reported improvements ≥MCID in HAQ-DI (74% vs 64%) and SF-36 PCS (79% vs 66%) and 4/8 domain scores (P<0.05). At week 12, UPA vs ABA treatment elicited greater improvements in key domains of physical functioning, pain, and general health and earlier improvements in HAQ-DI. Overall, more UPA- vs ABA-treated patients achieved ≥MCID in most PROs at all timepoints; however, not all differences were statistically significant. These data, however, highlight the faster response to UPA treatment. NCT03086343 , March 22, 2017.

中文翻译：

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患者报告的乌帕替尼与阿巴西普治疗类风湿性关节炎患者的结果以及对缓解病情的生物抗风湿药物反应不足的患者：一项 3 期试验的 12 周和 24 周结果


在之前的临床试验中，接受 upadacitinib (UPA) 治疗的活动性类风湿关节炎 (RA) 患者改善了患者报告的结果 (PRO)。这项对 SELECT-CHOICE（一项 3 期临床试验）的事后分析评估了 UPA 与阿巴西普 (ABA) 与传统合成缓解病情抗风湿药物 (csDMARD) 的比较，对生物制剂反应不足或不耐受的 RA 患者 PRO 的影响缓解疾病的抗风湿药（bDMARD-IR）。 SELECT-CHOICE 患者接受 UPA（口服 15 毫克/天）或 ABA（静脉注射）。评估的 PRO 包括通过视觉模拟量表 (VAS) 进行的患者疾病活动总体评估 (PtGA)、通过 VAS 进行的患者疼痛评估、健康评估问卷残疾指数 (HAQ-DI)、晨僵持续时间和严重程度、36 项简表健康调查 (SF-36)、慢性病治疗疲劳功能评估 (FACIT-F)、工作生产力和活动损伤 (WPAI) 以及 EQ-5D 5 级 (EQ-5D-5L) 指数评分。从基线到第 12 周和第 24 周的最小二乘均值 (LSM) 变化基于协方差模型分析。使用卡方检验比较报告改善≥最小临床重要差异（MCID）的患者比例。分析了 612 名患者的数据（UPA，n=303；ABA，n=309）。平均年龄为 56 岁，平均病程为 12 年。三分之一的人在基线时接受了 ≥2 种既往 bDMARD，72% 的人同时接受了甲氨蝶呤治疗。在第 12 周，UPA 治疗的患者与 ABA 治疗的患者相比，在 PtGA、疼痛、HAQ-DI、晨僵严重程度、EQ-5D-5L、2/4 WPAI 域和 3/8 SF-36 域以及身体方面有显着更大的改善。成分摘要 (PCS) 分数 (P<0.05);第 24 周，HAQ-DI、晨僵严重程度、SF-36 PCS 和身体疼痛领域以及 WPAI 活动障碍领域仍存在显着差异。在第 12 周，与 ABA 治疗相比，UPA 治疗的患者报告 HAQ-DI（74% vs 64%）和 SF-36 PCS（79% vs 66%）和 4/8 领域评分改善≥MCID（P<0 .05）。第 12 周时，UPA 与 ABA 治疗相比，在身体机能、疼痛和一般健康等关键领域带来了更大的改善，并且 HAQ-DI 也得到了更早的改善。总体而言，与 ABA 治疗的患者相比，更多的 UPA 治疗患者在所有时间点的大多数 PRO 中达到 ≥MCID；然而，并非所有差异都具有统计显着性。然而，这些数据突显了对 UPA 治疗的更快反应。 NCT03086343，2017 年 3 月 22 日。