From the University of Massachusetts Medical School, Worcester; Corrona LLC, Southborough, Massachusetts; Bristol-Myers Squibb, Princeton, New Jersey; Albany Medical College and The Center for Rheumatology, Albany, New York.
L.R. Harrold, MD, MPH, University of Massachusetts Medical School, and Corrona LLC; H.J. Litman, PhD, Corrona LLC; S.E. Connolly, PhD, Bristol-Myers Squibb; S. Kelly, MD, Bristol-Myers Squibb; W. Hua, MS, Corrona LLC; E. Alemao, MS, RPh, Bristol-Myers Squibb; L. Rosenblatt, MD, MPH, Bristol-Myers Squibb; S. Rebello, MPH, Corrona LLC; J.M. Kremer, MD, Corrona LLC, and Albany Medical College and The Center for Rheumatology.
J Rheumatol. 2018 Jan;45(1):32-39. doi: 10.3899/jrheum.170007. Epub 2017 Nov 1.
Assess whether baseline anticyclic citrullinated peptide antibodies (anti-CCP) status is associated with treatment response in patients with rheumatoid arthritis (RA) initiating abatacept (ABA) or a tumor necrosis factor-α inhibitor (TNFi).
Using the Corrona RA registry, patients were identified who initiated ABA or a TNFi (June 2004-January 2015), had a followup visit 6 months (± 3 mos) after initiation, and anti-CCP measured at or prior to initiation. Primary outcome was mean change in Clinical Disease Activity Index (CDAI) from initiation to 6 months. Treatment response was evaluated based on a typical patient profile (female, aged 57 yrs, body mass index of 30 kg/m, baseline CDAI of 20, 1 prior biologic, and no comorbidities other than RA). Secondary outcomes included remission and low disease activity.
There were 566 ABA initiators [anti-CCP+ (≥ 20 units/ml): n = 362; anti-CCP- (< 20 units/ml): n = 204] and 1715 TNFi initiators (anti-CCP+: n = 1113; anti-CCP-: n = 602). Differences between treatment groups included baseline disease duration, CDAI, and prior biologic use. At 6 months, anti-CCP+ ABA initiators were associated with significantly greater CDAI response versus anti-CCP- ABA initiators; no significant difference was observed for TNFi initiators. When considering a typical RA patient profile, CDAI response was greater in anti-CCP+ versus anti-CCP- ABA initiators; anti-CCP+ versus anti-CCP- TNFi initiators were similar. Secondary outcome responses were also greater in anti-CCP+ versus anti-CCP- ABA initiators; TNFi initiators did not differ by anti-CCP status.
In a US-based clinical practice setting, anti-CCP status was associated with a differential treatment response to ABA, but not TNFi.
评估基线抗环瓜氨酸肽抗体(anti-CCP)状态是否与类风湿关节炎(RA)患者起始阿巴西普(ABA)或肿瘤坏死因子-α抑制剂(TNFi)治疗的反应相关。
利用 Corrona RA 注册中心,确定了在 2004 年 6 月至 2015 年 1 月期间起始 ABA 或 TNFi 的患者,这些患者在起始治疗后 6 个月(±3 个月)进行了随访,并且在起始时或之前测量了抗 CCP。主要结局是从起始到 6 个月时临床疾病活动指数(CDAI)的平均变化。根据典型患者特征(女性,年龄 57 岁,体重指数为 30kg/m,基线 CDAI 为 20,1 种既往生物制剂,除 RA 外无其他合并症)评估治疗反应。次要结局包括缓解和低疾病活动度。
ABA 起始者中有 566 例(抗-CCP+(≥20 单位/ml):n=362;抗-CCP-(<20 单位/ml):n=204),TNFi 起始者中有 1715 例(抗-CCP+:n=1113;抗-CCP-:n=602)。治疗组之间的差异包括基线疾病持续时间、CDAI 和既往生物制剂的使用。在 6 个月时,与抗-CCP-ABA 起始者相比,抗-CCP+ABA 起始者的 CDAI 反应显著更大;但在 TNFi 起始者中未观察到显著差异。当考虑典型 RA 患者特征时,与抗-CCP-ABA 起始者相比,抗-CCP+ABA 起始者的 CDAI 反应更大;与抗-CCP-TNFi 起始者相比,抗-CCP+ABA 起始者相似。次要结局反应也在抗-CCP+ABA 起始者中更大;TNFi 起始者与抗 CCP 状态无关。
在基于美国的临床实践环境中,抗 CCP 状态与 ABA 的治疗反应相关,而与 TNFi 无关。