Efficacy and safety of different doses and retreatment of rituximab: A randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))

Paul Emery, A. Deodhar, W. F. Rigby, J. D. Isaacs, B. Combe, A. J. Racewicz, K. Latinis, C. Abud-Mendoza, L. J. Szczepański, R. A. Roschmann, A. Chen, G. K. Armstrong, W. Douglass, H. Tyrrell

Research output: Contribution to journalArticle

228 Scopus citations

Abstract

Objectives: This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Methods: Patients with active disease on stable MTX (10-25 mg/week) were randomised to rituximab 2x500 mg (n=168), rituximab 2x1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) ≥2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2x500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. Results: At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2x500 mg) + MTX, rituximab (2x1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Conclusions: Rituximab (at 2x500 mg and 2x1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses.

Original languageEnglish (US)
Pages (from-to)1629-1635
Number of pages7
JournalAnnals of the rheumatic diseases
Volume69
Issue number9
DOIs
StatePublished - Sep 1 2010

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

Fingerprint Dive into the research topics of 'Efficacy and safety of different doses and retreatment of rituximab: A randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))'. Together they form a unique fingerprint.

  • Cite this