Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study

被引:105
作者
Emery, P. [1 ,2 ]
Gottenberg, J. E. [3 ]
Rubbert-Roth, A. [4 ]
Sarzi-Puttini, P. [5 ]
Choquette, D. [6 ]
Martinez Taboada, V. M. [7 ]
Barile-Fabris, L. [8 ]
Moots, R. J. [9 ]
Ostor, A. [10 ]
Andrianakos, A. [11 ]
Gemmen, E. [12 ]
Mpofu, C. [13 ]
Chung, C. [14 ]
Gylvin, L. Hinsch [13 ]
Finckh, A. [15 ]
机构
[1] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Chapel Allerton Hosp, Leeds LS7 4SA, W Yorkshire, England
[2] Leeds Teaching Hosp NHS Trust, NIHR Leeds Musculoskeletal Biomed Res Unit, Leeds, W Yorkshire, England
[3] CHU Strasbourg, Dept Rheumatol, F-67000 Strasbourg, France
[4] Univ Cologne, D-50931 Cologne, Germany
[5] L Sacco Univ Hosp, Milan, Italy
[6] Univ Montreal, Montreal, PQ, Canada
[7] Univ Cantabria, Hosp Univ Marques de Valdecilla, Fac Med, E-39005 Santander, Spain
[8] Hosp Especialidades Ctr Med Nacl Siglo XXI, Inst Mexicano Seguro Social, Mexico City, DF, Mexico
[9] Univ Liverpool, Dept Rheumatol, Liverpool L69 3BX, Merseyside, England
[10] Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England
[11] Hellen Fdn Rheumatol Res, Athens, Greece
[12] Quintiles, Rockville, MD USA
[13] F Hoffmann La Roche Ltd, Basel, Switzerland
[14] Genentech Inc, San Francisco, CA 94080 USA
[15] Univ Hosp Geneva, Geneva, Switzerland
关键词
Rheumatoid Arthritis; DMARDs (biologic); Anti-TNF; B cells; Treatment; TUMOR-NECROSIS-FACTOR; INADEQUATE RESPONSE; CLINICAL-RESPONSE; BIOLOGICAL TREATMENT; INFLIXIMAB; ANTAGONISTS; ETANERCEPT; EFFICACY; THERAPY; ADALIMUMAB;
D O I
10.1136/annrheumdis-2013-203993
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives 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. Methods SWITCH-RA was a prospective, global, observational, real-life study. Patients non-responsive or intolerant to a single TNFi were enrolled 4weeks 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 6months. Results 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 6months 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. Conclusions 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.
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页码:979 / 984
页数:6
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