Rituximab Therapy in Rheumatoid Arthritis in Daily Practice

NOÉMIE ASSOUS, LAURE GOSSEC, PHILLIPPE DIEUDÉ, OLIVIER MEYER, MAXIME DOUGADOS, ANDRE KAHAN, and YANNICK ALLANORE

ABSTRACT.

Objective. Rituximab has been shown to be effective in refractory rheumatoid arthritis (RA) in randomized controlled trials, allowing approval by health agencies. Our aim was to assess in routine care the effects of rituximab in patients with RA who had experienced an inadequate response to anti-tumor necrosis factor-a (TNF-a) agents or had a contraindication to these drugs.

Methods. An observational retrospective study was conducted. Rituximab (1000 mg intravenous infusion on Days 1 and 15) was administered with concomitant methotrexate therapy. Responses defined according to the European League Against Rheumatism (EULAR criteria) were assessed at Week 24.

Results. Fifty patients were included: 30 had inadequate response to anti-TNF-a and 20 had contraindication to anti-TNF-a drugs. EULAR response was observed in 82%, good response in 36% (including remission in 12%), moderate response in 46%, and no response in 18%. One infusion-related reaction and 2 pulmonary infections occurred. Eleven of the 50 patients (22%) experienced flare and received retreatment with rituximab at 6 months. Thirty additional patients had flare after 6 months and the median delay for retreatment among the 41 responders was 9 (range 6–24) months. No difference regarding efficacy or tolerance of rituximab was observed according to previous inadequate response or contraindication to anti-TNF.

Conclusion. A single cycle of rituximab, in combination with continued methotrexate, provided significant improvement in disease activity at Week 24, with good tolerance, in patients with severe and active RA despite anti-TNF-a agents and/or with contraindication to these drugs, in this daily practice study. (First Release Nov 15 2007; J Rheumatol 2008;35:31-4)

Key Indexing Terms:

RITUXIMAB
RHEUMATOID ARTHRITIS
OPEN-LABEL TRIAL

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From the Departments of Rheumatology A and Rheumatology B, Paris Descartes University, Medical Faculty, Cochin Hospital, AP-HP, and Department of Rheumatology, Paris VII University, Bichat Hospital, AP-HP, Paris, France.

N. Assous, MD; A. Kahan, MD, PhD; Y. Allanore, MD, Department of Rheumatology A, Paris Descartes University; L. Gossec, MD, PhD; M. Dougados, MD, Rheumatology B, Paris Descartes University; P. Dieudé, MD, PhD; O. Meyer, MD, PhD, Department of Rheumatology, Paris VII University.

Address reprint requests to Dr. Y. Allanore, Hôpital Cochin, Service de Rhumatologie A, 27 rue du faubourg Saint Jacques, 75014 Paris, France. E-mail: yannick.allanore@cch.aphp.fr

Accepted for publication September 24, 2007.

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