Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial

• Published in: Chinese medical journal Vol. 136; no. 3; pp. 331 - 340
• Main Authors: Wang, Mengyan, Xue, Yu, Du, Fang, Ma, Lili, Lu, Liang-jing, Jiang, Lindi, Tao, Yi-Li, Yang, Chengde, Shi, Hui, Liu, Honglei, Cheng, Xiaobing, Ye, Junna, Su, Yutong, Zhao, Dongbao, Dai, Sheng-Ming, Teng, Jialin, Hu, Qiongyi
• Format: Journal Article
• Language: English
• Published: China Lippincott Williams & Wilkins 05.02.2023; Lippincott Williams & Wilkins Ovid Technologies; Wolters Kluwer
• Subjects: Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; China; Clinical trials; Disease control; Drug dosages; Drug withdrawal; Humans; Infections; Laboratories; Original; Patients; Piperidines - therapeutic use; Pyrroles - therapeutic use; Quality of Life; Remission (Medicine); Rheumatoid arthritis; Survival analysis; Treatment Outcome; Tumor necrosis factor-TNF; Viruses; China
• ISSN: 0366-6999; 2542-5641; 2542-5641
• DOI: 10.1097/CM9.0000000000002561

Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control. The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months. Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P  < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group. Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state. Chictr.org, ChiCTR2000039799.