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Ann Rheum Dis. 2015 Jun;74(6):979-84. doi: 10.1136/annrheumdis-2013-203993. Epub 2014 Jan 17.

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.

Author information

  • 1Leeds 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.
  • 2Department of Rheumatology, CHU Strasbourg, Strasbourg, France.
  • 3University of Cologne, Cologne, Germany.
  • 4L Sacco University Hospital, Milan, Italy.
  • 5University of Montreal, Montreal, Canada.
  • 6Facultad de Medicina, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Santander, Spain.
  • 7Hospital de Especialidades Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, México City, Mexico.
  • 8Department of Rheumatology, University of Liverpool, Liverpool, UK.
  • 9Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
  • 10Hellenic Foundation for Rheumatological Research, Athens, Greece.
  • 11Quintiles, Rockville, Maryland, USA.
  • 12F Hoffmann-La Roche Ltd, Basel, Switzerland.
  • 13Genentech Inc, San Francisco, California, USA.
  • 14University Hospital of Geneva, Geneva, Switzerland.

Abstract

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 ≤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.

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 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.

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.

KEYWORDS:

Anti-TNF; B cells; DMARDs (biologic); Rheumatoid Arthritis; Treatment

PMID:
24442884
PMCID:
PMC4431330
DOI:
10.1136/annrheumdis-2013-203993
[PubMed - indexed for MEDLINE]
Free PMC Article
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