Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study.

IF 5.1 2区 医学 Q1 RHEUMATOLOGY
Roy Fleischmann, Sebastian Meerwein, Christina Charles-Schoeman, Bernard Combe, Stephen Hall, Nasser Khan, Kyle M Carter, Heidi S Camp, Andrea Rubbert-Roth
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引用次数: 0

Abstract

Objective: To evaluate the efficacy and safety of upadacitinib over 5 years among patients with rheumatoid arthritis (RA) in a long-term extension (LTE) of the SELECT-BEYOND phase 3 trial.

Methods: Patients refractory to ≥1 biological disease-modifying antirheumatic drug (DMARD) received upadacitinib 15 mg or 30 mg once daily or placebo, in combination with background conventional synthetic DMARD(s). At week 12, patients randomised to placebo were switched to upadacitinib 15 mg or 30 mg. All patients who completed the week 24 visit could enter the LTE for up to 5 years. Efficacy was analysed as observed and by non-responder imputation through week 260. Treatment-emergent adverse events per 100 patient-years were summarised over 5 years.

Results: Of the 498 patients randomised, 418 (84%) completed week 24 and entered the LTE. Of those who remained in the trial (n=80, upadacitinib 15 mg; n=81, upadacitinib 30 mg), 36%/36% and 81%/77% randomised to upadacitinib 15/30 mg were in Clinical Disease Activity Index (CDAI) remission or low disease activity at week 260, respectively (as observed). Approximately 47% of all patients who began in high disease activity demonstrated a CDAI improvement >12 at week 260 with upadacitinib 15/30 mg. Functional and pain-related outcomes also showed comparable improvements with both doses. Numerically higher rates of anaemia, herpes zoster and creatine phosphokinase elevation were observed with upadacitinib 30 mg vs 15 mg. No new safety issues were identified.

Conclusions: Upadacitinib 15/30 mg continued to be effective in treating clinical and functional outcomes in patients with RA. The safety profile observed over 5 years was consistent with earlier study-specific and integrated assessments of upadacitinib treatment.

奥达帕替尼对类风湿关节炎和生物治疗反应不充分或不耐受患者的疗效和安全性:SELECT-BEYOND 研究 5 年来的结果。
目的在 SELECT-BEYOND 3 期试验的长期扩展(LTE)中,评估达帕他替尼对类风湿关节炎(RA)患者 5 年的疗效和安全性:方法:对≥1种生物修饰性抗风湿药(DMARD)难治的患者接受达达替尼15毫克或30毫克,每天一次或安慰剂,与背景常规合成DMARD联合使用。在第12周,随机接受安慰剂治疗的患者转为接受达达替尼15毫克或30毫克的治疗。所有完成第24周访视的患者均可参加长达5年的LTE。疗效分析以观察结果为准,并对第260周前的非应答者进行归因。对5年内每100例患者/年的治疗突发不良事件进行了总结:在随机抽取的 498 名患者中,有 418 人(84%)完成了第 24 周的治疗并参加了 LTE。在继续参与试验的患者中(80人,达帕替尼15毫克;81人,达帕替尼30毫克),随机接受达帕替尼15/30毫克治疗的患者中,分别有36%/36%和81%/77%在第260周时处于临床疾病活动指数(CDAI)缓解或低疾病活动期(如观察结果)。在所有开始时疾病活动度较高的患者中,约有47%的患者在服用达达替尼15/30毫克后第260周的CDAI改善幅度大于12。两种剂量对功能和疼痛相关结果的改善也不相上下。达帕替尼30毫克与15毫克相比,贫血、带状疱疹和肌酸磷酸激酶升高的发生率较高。未发现新的安全性问题:结论:达帕替尼15/30毫克在治疗RA患者的临床和功能结果方面仍然有效。5年来所观察到的安全性状况与早前针对乌达替尼治疗的研究和综合评估结果一致。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
RMD Open
RMD Open RHEUMATOLOGY-
CiteScore
7.30
自引率
6.50%
发文量
205
审稿时长
14 weeks
期刊介绍: RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.
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