Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
10.1097/CM9.0000000000002561
- VernacularTitle:Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial
- Author:
Mengyan WANG
1
;
Yu XUE
2
;
Fang DU
3
;
Lili MA
4
;
Liang-Jing LU
3
;
Lindi JIANG
4
;
Yi-Li TAO
5
;
Chengde YANG
1
;
Hui SHI
1
;
Honglei LIU
1
;
Xiaobing CHENG
1
;
Junna YE
1
;
Yutong SU
1
;
Dongbao ZHAO
6
;
Sheng-Ming DAI
5
;
Jialin TENG
1
;
Qiongyi HU
1
Author Information
1. Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
2. Department of Rheumatology and Immunology, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China.
3. Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200127, China.
4. Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
5. Department of Rheumatology and Immunology, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.
6. Department of Rheumatology and Immunology, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
- Publication Type:Journal Article
- MeSH:
Humans;
Quality of Life;
China;
Arthritis, Rheumatoid/drug therapy*;
Piperidines/therapeutic use*;
Treatment Outcome;
Antirheumatic Agents/therapeutic use*;
Pyrroles/therapeutic use*
- From:
Chinese Medical Journal
2023;136(3):331-340
- CountryChina
- Language:English
-
Abstract:
BACKGROUND: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.
METHODS: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.
RESULTS: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.
CONCLUSION: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.
TRIAL REGISTRATION:Chictr.org, ChiCTR2000039799.
