Supplementary materials: Real-world clinical outcomes and rationale for initiating abatacept as a first-line biologic for patients with anticitrullinated protein antibody- and rheumatoid factor-positive rheumatoid arthritis

These are peer-reviewed supplementary materials for the article 'Real-world clinical outcomes and rationale for initiating abatacept as a first-line biologic for patients with anticitrullinated protein antibody- and rheumatoid factor-positive rheumatoid arthritis' published in the Journal of Comparative Effectiveness Research.Supplemental methods: Study interval context: parameters around Clinical Disease Activity Index (CDAI) measuresSupplemental results: Rheumatologist characteristicsTable S1: Characteristics of treating rheumatologists.Figure S1: Time to CDAI remission alone during treatment with abatacept as a first-line bDMARD.Aim: In rheumatoid arthritis (RA), seropositivity for both anticitrullinated protein antibody (ACPA) and rheumatoid factor (RF) is associated with disease severity and therapeutic response. Biologic (b) diseasemodifying antirheumatic drugs (DMARDs) such as abatacept are recommended after inadequate response or contraindication to conventional synthetic DMARDs. This retrospective cohort study aimed to describe changes in Clinical Disease Activity Index (CDAI) measures over 12 months among patients with ACPA+ and RF+ RA with an inadequate response to methotrexate treated with abatacept as a first-line bDMARD. Patients & methods: Patient data were abstracted from medical records by treating rheumatologists. Analyses included McNemar tests for paired proportions or paired t-tests to assess longitudinal changes in CDAI scores, and Kaplan–Meier methods for time-to-event outcomes. Serious AEs and rationale for initiating treatment were recorded. Results: Overall, 296 patients were included. Mean CDAI scores improved (decreased) by 34.0, 61.0 and 74.0% (all p < 0.001) from baseline to 3–6 months, 6–12 months and ≥12 months after abatacept initiation, respectively. Of 279 patients not in CDAI low disease activity (LDA) or remission at baseline, 24.7% of patients achieved it within 6 months, 56.3% within 12 months and 71.0% at any point during follow-up after abatacept initiation. Median time to CDAI LDA/remission was 10.2 months. Serious AEs were reported in 2.4% of patients. Common reasons reported by rheumatologists for initiating abatacept were effectiveness/efficacy (52.7%), safety (31.4%) and patient preference (25.3%). Conclusion: In this analysis of patients with ACPA+ and RF+ RA treated with abatacept as a firstline bDMARD in a clinical practice setting, clinical outcomes and remission rates were improved at all time points, providing real-world evidence to further support the use of abatacept in this patient population.

本数据集为发表于《比较疗效研究杂志》的论文《抗环瓜氨酸蛋白抗体和类风湿因子阳性类风湿关节炎患者启动阿巴特cept作为一线生物制剂的真实世界临床疗效及治疗依据》的同行评审补充材料。补充方法：研究期间背景：围绕临床疾病活动指数（CDAI）的参数。补充结果：风湿科医生特征。表S1：治疗风湿科医生的特征。图S1：以阿巴特cept作为一线生物调节性抗风湿药（bDMARD）治疗期间，单独达到CDAI缓解的时间。研究目标：在类风湿关节炎（RA）中，抗环瓜氨酸蛋白抗体（ACPA）和类风湿因子（RF）的双重血清阳性与疾病严重程度和治疗反应相关。对于对传统合成DMARDs反应不足或存在禁忌症的患者，建议使用生物制剂（b）疾病调节性抗风湿药（DMARDs）如阿巴特cept。本研究旨在描述ACPA+和RF+ RA患者在使用阿巴特cept作为一线bDMARD治疗12个月期间，临床疾病活动指数（CDAI）指标的变化。患者与方法：由治疗风湿科医生从病历中提取患者数据。分析包括McNemar检验用于成对比例的纵向变化评估CDAI分数，以及Kaplan-Meier方法用于时间至事件结果。记录严重不良事件（AEs）和治疗启动的依据。结果：总计纳入296名患者。阿巴特cept启动后，基线至3-6个月、6-12个月和≥12个月，CDAI平均分数分别改善了（降低）34.0、61.0和74.0%（所有p < 0.001）。在基线时未处于CDAI低疾病活动（LDA）或缓解状态的279名患者中，24.7%的患者在6个月内、56.3%的患者在12个月内、71.0%的患者在治疗启动后的随访期间任何时间点达到了LDA或缓解。CDAI LDA/缓解的中位时间为10.2个月。2.4%的患者报告了严重AEs。风湿科医生报告启动阿巴特cept的常见原因包括有效性/功效（52.7%）、安全性（31.4%）和患者偏好（25.3%）。结论：在本分析中，对在临床实践环境中接受阿巴特cept作为一线bDMARD治疗的ACPA+和RF+ RA患者进行分析，发现所有时间点的临床疗效和缓解率均有所改善，为阿巴特cept在该患者群体中的应用提供了真实世界的证据。