BACKGROUND There are limited data regarding efficacy of abatacept treatment for rheumatoid arthritis (RA) outside clinical trials. Quality registers have been useful for observational studies on tumor necrosis factor inhibition in clinical practice. The aim of this study was to investigate clinical efficacy and tolerability of abatacept in RA, using a national register. METHODS RA patients that started abatacept between 2006 and 2017 and were included in the Swedish Rheumatology Quality register (N = 2716) were investigated. Survival on drug was estimated using Kaplan-Meier analysis. The European League Against Rheumatism (EULAR) good response and Health Assessment Questionnaire (HAQ) response (improvement of ≥ 0.3) rates (LUNDEX corrected for drug survival) at 6 and at 12 months were assessed. Predictors of discontinuation were investigated by Cox regression analyses, and predictors of clinical response by logistic regression. Significance-based backward stepwise selection of variables was used for the final multivariate models. RESULTS There was a significant difference in drug survival by previous biologic disease-modifying antirheumatic drug (bDMARD) exposure (p < 0.001), with longer survival in bionaïve patients. Men (hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.74-0.98) and methotrexate users (HR 0.85, 95% CI 0.76-0.95) were less likely to discontinue abatacept, whereas a high pain score predicted discontinuation (HR 1.14 per standard deviation, 95% CI 1.07-1.20). The absence of previous bDMARD exposure, male sex, and a low HAQ score were independently associated with LUNDEX-corrected EULAR good response. The absence of previous bDMARD exposure also predicted LUNDEX-corrected HAQ response. CONCLUSIONS In this population-based study of RA, bDMARD naïve patients and male patients were more likely to remain on abatacept with a major clinical response.

中文翻译：

---

阿巴西普治疗类风湿性关节炎：药物生存率、临床结果及其预测因素——来自大型国家质量登记册的数据。

背景关于阿巴西普治疗类风湿性关节炎（RA）的疗效，临床试验之外的数据有限。质量登记册对于临床实践中肿瘤坏死因子抑制的观察性研究非常有用。本研究的目的是利用国家登记册研究阿巴西普治疗 RA 的临床疗效和耐受性。方法 对 2006 年至 2017 年间开始使用阿巴西普并被纳入瑞典风湿病质量登记册 (N = 2716) 的 RA 患者进行了调查。使用 Kaplan-Meier 分析估计药物存活率。对第 6 个月和第 12 个月时的欧洲抗风湿病联盟 (EULAR) 良好反应和健康评估问卷 (HAQ) 反应（改善≥ 0.3）率（LUNDEX 校正药物生存率）进行了评估。通过 Cox 回归分析研究停药的预测因素，通过逻辑回归研究临床反应的预测因素。基于显着性的向后逐步选择变量用于最终的多元模型。结果 既往生物疾病缓解抗风湿药物 (bDMARD) 暴露的药物生存率存在显着差异 (p < 0.001)，且未接受过生物治疗的患者生存期较长。男性（风险比 (HR) 0.86，95% 置信区间 (CI) 0.74-0.98）和甲氨蝶呤使用者（HR 0.85，95% CI 0.76-0.95）不太可能停止阿巴西普，而高疼痛评分预示着停止（HR每个标准差为 1.14，95% CI 1.07-1.20）。既往没有 bDMARD 暴露、男性和低 HAQ 评分与 LUNDEX 校正的 EULAR 良好反应独立相关。之前没有接触过 bDMARD 也可以预测 LUNDEX 校正后的 HAQ 反应。结论 在这项基于人群的 RA 研究中，未接受过 bDMARD 治疗的患者和男性患者更有可能继续服用阿巴西普，并取得重大临床反应。