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, Atulya (Atul) 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

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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

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

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Retreatment
Methotrexate
Rheumatoid Arthritis
Randomized Controlled Trials
Placebos
Safety
Rituximab
Joints

ASJC Scopus subject areas

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

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

In: Annals of the Rheumatic Diseases, Vol. 69, No. 9, 09.2010, p. 1629-1635.

Research output: Contribution to journalArticle

Emery, Paul ; Deodhar, Atulya (Atul) ; Rigby, W. F. ; Isaacs, J. D. ; Combe, B. ; Racewicz, A. J. ; Latinis, K. ; Abud-Mendoza, C. ; Szczepański, L. J. ; Roschmann, R. A. ; Chen, A. ; Armstrong, G. K. ; Douglass, W. ; Tyrrell, H. / 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)). In: Annals of the Rheumatic Diseases. 2010 ; Vol. 69, No. 9. pp. 1629-1635.
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