Kjørholt Kaja E, Sundlisæter Nina Paulshus, Aga Anna-Birgitte, Sexton Joseph, Olsen Inge C, Lexberg Åse S, Madland Tor M, Fremstad Hallvard, Høili Christian A, Bakland Gunnstein, Spada Cristina, Haukeland Hilde, Hansen Inger M, Moholt Ellen, Holten Karen, Uhlig Till, Kvien Tore K, Solomon Daniel H, van der Heijde Désirée, Haavardsholm Espen A, Lillegraven Siri
Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Faculty of Medicine, University of Oslo, Oslo, Norway.
Arthritis Rheumatol. 2025 Apr 28. doi: 10.1002/art.43199.
Tapering of tumor necrosis factor inhibitor (TNFi) treatment in rheumatoid arthritis (RA) remission is debated. We assessed the effect of tapering TNFi to withdrawal versus continued stable TNFi on flare-free survival and joint damage progression over three years.
ARCTIC REWIND was a multicenter, open-label, non-inferiority trial including patients with RA in remission for ≥12 months on stable TNFi therapy. Patients were randomized 1:1 to taper TNFi to withdrawal or continue stable treatment. The primary endpoints of the current study were flare-free survival and radiographic progression over three years. Flare-free survival was analyzed by Kaplan-Meier methods, flare rates by Cox regression, and radiographic progression by logistic mixed effects models.
Of 99 randomized patients, 92 received the allocated therapy, 80 completed 3-year follow-up. Mean baseline DAS based on 44 joint count was 0.8, csDMARD co-medication was used by 90%. After 3 years, 25% (95%CI: 13-38%) remained flare-free in the tapering TNFi group compared to 85% (70-93%) in the stable group, corresponding hazard ratio for flare 9.4 (3.9-22.8), p<0.0001. In the tapering group 6/41 (15%) experienced radiographic progression, compared with 3/38 (8%) in the stable group, risk difference 6.7% (-7.1%-20.5%, p=0.3). Adverse events occurred in 81% of the patients in the tapering group, and 89% of the patients in the stable group.
In contrast to those receiving stable TNFi treatment, a minority of RA patients in remission tapering TNFi to withdrawal remained flare-free over three years. There was no statistically significant difference in radiographic progression between the groups.
类风湿关节炎（RA）缓解期肿瘤坏死因子抑制剂（TNFi）治疗的减量存在争议。我们评估了TNFi减量至停药与持续稳定使用TNFi对三年无复发生存期和关节损伤进展的影响。
ARCTIC REWIND是一项多中心、开放标签、非劣效性试验，纳入了在稳定TNFi治疗下缓解≥12个月的RA患者。患者按1:1随机分组，一组将TNFi减量至停药，另一组继续稳定治疗。本研究的主要终点是三年无复发生存期和影像学进展。无复发生存期采用Kaplan-Meier方法分析，复发率采用Cox回归分析，影像学进展采用逻辑混合效应模型分析。
99例随机分组患者中，92例接受了分配的治疗，80例完成了3年随访。基于44个关节计数的平均基线疾病活动度评分（DAS）为0.8，90%的患者联合使用了传统合成改善病情抗风湿药（csDMARD）。3年后，TNFi减量组25%（95%CI：13 - 38%）无复发，而稳定组为85%（70 - 93%），复发的相应风险比为9.4（3.9 - 22.8），p<0.0001。减量组41例中有6例（15%）出现影像学进展，稳定组为3/38（8%），风险差异为6.7%（-7.1% - 20.5%，p = 0.3）。减量组81%的患者发生不良事件，稳定组为89%。
与接受稳定TNFi治疗的患者相比，少数缓解期RA患者将TNFi减量至停药后三年无复发。两组间影像学进展无统计学显著差异。
