利妥昔单抗治疗既往接受过抗TNF治疗的类风湿关节炎患者的疗效：CORRONA注册研究结果

Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry.

作者信息

Harrold Leslie R, Reed George W, Shewade Ashwini, Magner Robert, Saunders Katherine C, John Ani, Kremer Joel M, Greenberg Jeffrey D

机构信息

From the University of Massachusetts Medical School, Worcester; Corrona LLC, Southborough, Massachusetts; Genentech Inc., South San Francisco, California; Albany Medical College and The Center for Rheumatology, Albany; New York University (NYU) School of Medicine, New York, New York, USA.L.R. Harrold, MD, MPH, Department of Medicine, University of Massachusetts Medical School; G.W. Reed, PhD, Department of Medicine, University of Massachusetts Medical School, and Corrona LLC; A. Shewade, MS, Genentech Inc.; R. Magner, MPH, Department of Medicine, University of Massachusetts Medical School; K.C. Saunders, MS, Corrona LLC; A. John, BSN, MPH, Genentech Inc.; J.M. Kremer, MD, Department of Rheumatology, Albany Medical College, and The Center for Rheumatology; J.D. Greenberg, MD, MPH, Department of Medicine, Division of Rheumatology, NYU School of Medicine.

出版信息

J Rheumatol. 2015 Jul;42(7):1090-8. doi: 10.3899/jrheum.141043. Epub 2015 May 1.

DOI:10.3899/jrheum.141043

PMID:25934829

Abstract

OBJECTIVE

To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.

METHODS

Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.

RESULTS

Patients (n = 265) were followed for 12 months with a mean change in CDAI of -8.1 (95% CI -9.8 - -6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of -10.1 (95% CI -13.2 - -7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of -10.5 (95% CI -12.9 - -8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22-0.73), which was robust to 4 different adjusted models (OR range 0.38-0.44).

CONCLUSION

A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.

摘要

目的

评估利妥昔单抗（RTX）在类风湿关节炎患者中的真实世界疗效。

方法

基于临床疾病活动指数（CDAI）对接受RTX治疗的患者进行12个月的临床疗效评估。计算CDAI的变化（12个月时的CDAI减去起始时的CDAI）。使用逻辑回归模型，比较在RTX起始时具有中度/高度疾病活动的患者中，根据既往抗肿瘤坏死因子药物（抗TNF）使用情况（1次与≥2次）实现缓解或低疾病活动（LDA；CDAI≤10）的情况。

结果

对265例患者进行了12个月的随访，CDAI的平均变化为-8.1（95%CI -9.8 - -6.4）。在基线时具有中度/高度疾病活动的218例患者中，既往使用过1次抗TNF的患者（基线CDAI 25.0）CDAI的平均变化为-10.1（95%CI -13.2 - -7.0）；既往使用过≥2次抗TNF的患者（基线CDAI 30.0）CDAI的平均变化为-10.5（95%CI -12.9 - -8.0）。在基线时具有中度/高度疾病活动、既往使用≥2次抗TNF与使用1次抗TNF的患者中，实现LDA/缓解的未调整OR为0.40（95%CI 0.22-0.73），在4种不同的调整模型中该结果均稳健（OR范围为0.38-0.44）。