To evaluate the effect of upadacitinib on patient-reported outcomes (PROs) in patients with RA who had an inadequate response to csDMARDs. Patients in SELECT-NEXT, a randomised controlled trial, were on a background of csDMARDs and received upadacitinib 15 mg and 30 mg or placebo daily for 12 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS). Least squares mean (LSM) changes were based on mixed-effect repeated measure models. Percentages of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT) were determined; group comparisons used chi-square tests. Data from 661 patients were analysed. Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12. Significantly, more upadacitinib-treated patients (both doses, P < 0.05) reported improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains). For most PROs, the incremental NNT with upadacitinib to report clinically meaningful improvement from baseline ranged from 4 to 8 patients. Upadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability among csDMARD-IR patients with RA. Clinicaltrials.gov, NCT02675426. Retrospectively registered 5 February 2016.

中文翻译：

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Upadacitinib可改善类风湿性关节炎患者的治疗效果，并且对传统的可改变疾病的合成抗风湿药的反应不足：SELECT-NEXT的结果。

评估upadacitinib对对csDMARDs反应不足的RA患者的患者报告结局（PROs）的影响。SELECT-NEXT（一项随机对照试验）的患者以csDMARDs为背景，每天接受15 mg和30 mg的upadacitinib或安慰剂治疗12周。专业人士包括患者疾病活动总体评估（PtGA），疼痛，健康评估问卷-残疾指数（HAQ-DI），慢性病治疗疲劳功能评估（FACIT-F），早晨关节僵直的持续时间和严重程度（AM） ，简短表格36健康调查（SF-36）和RA的工作不稳定量表（RA-WIS）。最小二乘均方（LSM）变化基于混合效应重复测量模型。确定报告改善≥最小临床重要差异（MCID）和得分≥规范值和需要治疗的人数（NNT）的患者百分比；组比较使用卡方检验。分析了来自661例患者的数据。与安慰剂相比，接受upadacitinib的患者在PtGA，疼痛，HAQ-DI，FACIT-F，AM僵硬的持续时间和严重程度，SF-36（PCS和6/8域）方面有统计学上的显着改善（两个剂量，P <0.05） ，以及在第12周时出现RA-WIS。重要的是，更多接受upadacitinib治疗的患者（均为剂量，P <0.05）报告的PtGA，疼痛，HAQ-DI，FACIT-F，AM僵硬，SF-36（PCS和4个或7/8个域）和RA-WIS，并且HAQ-DI，FACIT-F和SF-36中的得分≥规范值（PCS和4个或5/8个域）。对于大多数专业人士而言，使用upadacitinib的NNT增量报告从基线到临床有有意义的改善，范围为4到8位患者。Upadacitinib每天15 mg或30 mg，持续12周，导致csDMARD-IR合并RA的患者的总体疾病活动，疼痛，身体机能，疲劳，AM僵硬的持续时间和严重程度，HRQOL以及工作不稳定性得到显着且临床上有意义的改善。Clinicaltrials.gov，NCT02675426。追溯注册于2016年2月5日。