Emery P, Gottenberg J E, Rubbert-Roth A, Sarzi-Puttini P, Choquette D, Taboada V M Martínez, Barile-Fabris L, Moots R J, Ostor A, Andrianakos A, Gemmen E, Mpofu C, Chung C, Gylvin L Hinsch, Finckh A
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Department of Rheumatology, CHU Strasbourg, Strasbourg, France.
Ann Rheum Dis. 2015 Jun;74(6):979-84. doi: 10.1136/annrheumdis-2013-203993. Epub 2014 Jan 17.
To compare the effectiveness of rituximab versus an alternative tumour necrosis factor (TNF) inhibitor (TNFi) in patients with rheumatoid arthritis (RA) with an inadequate response to one previous TNFi.
SWITCH-RA was a prospective, global, observational, real-life study. Patients non-responsive or intolerant to a single TNFi were enrolled ≤4 weeks after starting rituximab or a second TNFi. Primary end point: change in Disease Activity Score in 28 joints excluding patient's global health component (DAS28-3)-erythrocyte sedimentation rate (ESR) over 6 months.
604 patients received rituximab, and 507 an alternative TNFi as second biological therapy. Reasons for discontinuing the first TNFi were inefficacy (n=827), intolerance (n=263) and other (n=21). A total of 728 patients were available for primary end point analysis (rituximab n=405; TNFi n=323). Baseline mean (SD) DAS28-3-ESR was higher in the rituximab than the TNFi group: 5.2 (1.2) vs 4.8 (1.3); p<0.0001. Least squares mean (SE) change in DAS28-3-ESR at 6 months was significantly greater in rituximab than TNFi patients: -1.5 (0.2) vs -1.1 (0.2); p=0.007. The difference remained significant among patients discontinuing the initial TNFi because of inefficacy (-1.7 vs -1.3; p=0.017) but not intolerance (-0.7 vs -0.7; p=0.894). Seropositive patients showed significantly greater improvements in DAS28-3-ESR with rituximab than with TNFi (-1.6 (0.3) vs -1.2 (0.3); p=0.011), particularly those switching because of inefficacy (-1.9 (0.3) vs -1.5 (0.4); p=0.021). The overall incidence of adverse events was similar between the rituximab and TNFi groups.
These real-life data indicate that, after discontinuation of an initial TNFi, switching to rituximab is associated with significantly improved clinical effectiveness compared with switching to a second TNFi. This difference was particularly evident in seropositive patients and in those switched because of inefficacy.
比较利妥昔单抗与另一种肿瘤坏死因子（TNF）抑制剂（TNFi）对先前使用一种TNFi治疗反应不佳的类风湿关节炎（RA）患者的疗效。
SWITCH - RA是一项前瞻性、全球性、观察性、真实世界研究。对单一TNFi无反应或不耐受的患者在开始使用利妥昔单抗或第二种TNFi后≤4周入组。主要终点：28个关节疾病活动评分（不包括患者整体健康状况部分，即DAS28 - 3）-红细胞沉降率（ESR）在6个月内的变化。
604例患者接受了利妥昔单抗治疗，507例患者接受了另一种TNFi作为第二种生物治疗。停用第一种TNFi的原因包括无效（n = 827）、不耐受（n = 263）和其他（n = 21）。共有728例患者可进行主要终点分析（利妥昔单抗组n = 405；TNFi组n = 323）。利妥昔单抗组的基线平均（标准差）DAS28 - 3 - ESR高于TNFi组：5.2（1.2）对4.8（1.3）；p<0.0001。6个月时利妥昔单抗组DAS28 - 3 - ESR的最小二乘均值（标准误）变化显著大于TNFi组患者：-1.5（0.2）对-1.1（0.2）；p = 0.007。在因无效而停用初始TNFi的患者中，这种差异仍然显著（-1.7对-1.3；p = 0.017），但在不耐受患者中无显著差异（-0.7对-0.7；p = 0.894）。血清学阳性患者中，利妥昔单抗治疗后DAS28 - 3 - ESR的改善显著大于TNFi治疗（-1.6（0.3）对-1.2（0.3）；p = 0.011），尤其是因无效而换药的患者（-1.9（0.3）对-1.5（0.4）；p = 0.021）。利妥昔单抗组和TNFi组不良事件的总体发生率相似。
这些真实世界数据表明，在停用初始TNFi后，与换用第二种TNFi相比，换用利妥昔单抗与临床疗效显著改善相关。这种差异在血清学阳性患者和因无效而换药的患者中尤为明显。
