Efficacy of B-Cell-Targeted Therapy with Rituximab in Patients with Rheumatoid Arthritis

doi:10.1056/NEJMoa032534

Volume 350:2572-2581		June 17, 2004		Number 25

Efficacy of B-Cell–Targeted Therapy with Rituximab in Patients with Rheumatoid Arthritis

Jonathan C.W. Edwards, M.D., Leszek Szczepanski, M.D., Ph.D., Jacek Szechinski, M.D., Ph.D., Anna Filipowicz-Sosnowska, M.D., Ph.D., Paul Emery, M.D., David R. Close, Ph.D., Randall M. Stevens, M.D., and Tim Shaw, B.Sc.

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ABSTRACT

Background An open-label study indicated that selective depletionof B cells with the use of rituximab led to sustained clinicalimprovements for patients with rheumatoid arthritis. To confirmthese observations, we conducted a randomized, double-blind,controlled study.

Methods We randomly assigned 161 patients who had active rheumatoidarthritis despite treatment with methotrexate to receive oneof four treatments: oral methotrexate ( $≥$ 10 mg per week) (control);rituximab (1000 mg on days 1 and 15); rituximab plus cyclophosphamide(750 mg on days 3 and 17); or rituximab plus methotrexate. Responsesdefined according to the criteria of the American College ofRheumatology (ACR) and the European League against Rheumatism(EULAR) were assessed at week 24 (primary analyses) and week48 (exploratory analyses).

Results At week 24, the proportion of patients with 50 percentimprovement in disease symptoms according to the ACR criteria,the primary end point, was significantly greater with the rituximab–methotrexatecombination (43 percent, P=0.005) and the rituximab–cyclophosphamidecombination (41 percent, P=0.005) than with methotrexate alone(13 percent). In all groups treated with rituximab, a significantlyhigher proportion of patients had a 20 percent improvement indisease symptoms according to the ACR criteria (65 to 76 percentvs. 38 percent, P $≤$ 0.025) or had EULAR responses (83 to 85 percentvs. 50 percent, P $≤$ 0.004). All ACR responses were maintained atweek 48 in the rituximab–methotrexate group. The majorityof adverse events occurred with the first rituximab infusion:at 24 weeks, serious infections occurred in one patient (2.5percent) in the control group and in four patients (3.3 percent)in the rituximab groups. Peripheral-blood immunoglobulin concentrationsremained within normal ranges.

Conclusions In patients with active rheumatoid arthritis despitemethotrexate treatment, a single course of two infusions ofrituximab, alone or in combination with either cyclophosphamideor continued methotrexate, provided significant improvementin disease symptoms at both weeks 24 and 48.

Source Information

From University College London, London (J.C.W.E.); Medical University School of Lublin, Lublin, Poland (L.S.); University School of Wroclaw, Wroclaw, Poland (J.S.); the Institute of Rheumatology, Warsaw, Poland (A.F.-S.); Leeds Royal Infirmary, Leeds, United Kingdom (P.E.); Roche Products, Welwyn Garden City, Hertfordshire, United Kingdom (D.R.C., T.S.); and Roche, Nutley, N.J. (R.M.S.).

Address reprint requests to Professor Edwards at the Centre for Rheumatology, University College London, 4th Fl., Arthur Stanley House, 40-50 Tottenham St., London W1P 9PG, United Kingdom, or at jo.edwards{at}ucl.ac.uk.

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Rituximab for Rheumatoid Arthritis
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N Engl J Med 2004; 351:1909, Oct 28, 2004. Correspondence

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