Objectives This study aimed to elucidate which bio-naïve patients with rheumatoid arthritis (RA) are suitable for treatment with CTLA4-Ig. Methods This study enrolled 953 patients with RA who were administered their first biological disease-modifying antirheumatic drug (CTLA4-Ig, n = 328; tumour necrosis factor inhibitor [TNFi], n = 625) from July 2013 to August 2022. The primary outcome was the Clinical Disease Activity Index (CDAI) remission rate at week 24 in each group, adjusted using Propensity Score-based Inverse Probability of Treatment Weighting (PS-IPTW). Results After minimizing selection bias using PS-IPTW, the CDAI remission showed no significant difference between the CTLA4-Ig and TNFi groups (p= 0.464). Multivariable logistic regression analysis identified low baseline Health Assessment Questionnaire–Disability Index (HAQ-DI) scores as a contributing factor to the CDAI remission rate at week 24 in both groups, along with high baseline anti-citrullinated peptide antibody (ACPA) levels in the CTLA4-Ig group. However, among patients with high baseline HAQ-DI scores and low baseline ACPA levels (≦57.2), the CDAI remission rate was significantly higher in the TNFi group (29.8%) compared with the CTLA4-Ig group (5.9%, p< 0.0001). Among patients with high baseline HAQ-DI scores and ACPA levels (>57.2), the CDAI remission rate was significantly higher in the CTLA4-Ig group (35.6%) compared with the TNFi group (22.1%, p= 0.0057). Conclusion Bio-naive RA patients with low HAQ-DI scores showed high treatment efficacy with no significant difference between CTLA4-Ig and TNFi. Among patients with high baseline HAQ-DI scores, TNFi and CTLA4-Ig were more likely to be effective in those with lower and higher baseline ACPA levels, respectively.

中文翻译：

---

类风湿性关节炎患者一线 CTLA4-Ig 疗效的预测因子：FIRST 注册


目的 本研究旨在阐明哪些未接受过生物治疗的类风湿性关节炎 （RA） 患者适合接受 CTLA4-Ig 治疗。方法 本研究入组了 2013 年 7 月至 2022年8月接受第一种生物疾病缓解抗风湿药 （CTLA4-Ig，n = 328;肿瘤坏死因子抑制剂 [TNFi]，n = 625） 的 RA 患者。主要结局是每组第 24 周的临床疾病活动指数 （CDAI） 缓解率，使用基于倾向评分的治疗加权逆概率 （PS-IPTW） 进行调整。结果 使用 PS-IPTW 最小化选择偏倚后，CTLA4-Ig 和 TNFi 组之间的 CDAI 缓解显示无显著差异 （p= 0.464）。多变量 logistic 回归分析发现，低基线健康评估问卷-残疾指数 （HAQ-DI） 评分是两组第 24 周 CDAI 缓解率的一个影响因素，同时 CTLA4-Ig 组的基线抗瓜氨酸肽抗体 （ACPA） 水平高。然而，在基线 HAQ-DI 评分高和基线 ACPA 水平低 （≦57.2） 的患者中，TNFi 组 （29.8%） 的 CDAI 缓解率显著高于 CTLA4-Ig 组 （5.9%，p< 0.0001）。在基线 HAQ-DI 评分和 ACPA 水平高 （>57.2） 的患者中，CTLA4-Ig 组 （35.6%） 的 CDAI 缓解率显著高于 TNFi 组 （22.1%，p= 0.0057）。结论 HAQ-DI 评分低的生物初治 RA 患者治疗效果高，CTLA4-Ig 和 TNFi 之间无显著差异。在基线 HAQ-DI 评分较高的患者中，TNFi 和 CTLA4-Ig 分别对基线 ACPA 水平较低和较高的患者更可能有效。