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Rheumatology Advance Access published online on October 24, 2006
Rheumatology, doi:10.1093/rheumatology/kel358
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© 2006 The Author(s) This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received June 6, 2006
Accepted September 19, 2006

Original Papers

Sustained benefit in rheumatoid arthritis following one course of rituximab: improvements in physical function over 2 years

V. Strand 1 *, A. Balbir-Gurman 2, K. Pavelka 3, P. Emery 4, N. Li 5, M. Yin 5, P. B. Lehane 6, and S. Agarwal 5

1 Division of Immunology, Stanford University, Palo Alto, CA, USA
2 B. Shine Department of Rheumatology, Rambam Medical Center, Haifa, Israel
3 Institute of Rheumatology, Prague University, Prague, Czech Republic, UK
4 Department of Rheumatology, University of Leeds, Leeds, UK
5 Biostatistics and Clinical Science, Genentech, Inc., South San Francisco, CA, USA
6 Clinical Science, Roche Products Ltd, Welwyn Garden City, UK

* To whom correspondence should be addressed.
V. Strand, E-mail: vstrand{at}aol.com


  Abstract

Objectives. To evaluate the long-term impact on physical function of a single course of rituximab in rheumatoid factor, seropositive patients with active rheumatoid arthritis (RA) despite ongoing methotrexate treatment.

Methods. A randomized, controlled trial comparing rituximab alone [1000 mg intravenously (iv) on days 1 and 15, n = 40], or in combination with cyclophosphamide (750 mg iv on days 3 and 7, n = 41) or oral methotrexate (≥10 mg/week, n = 40) with placebo + methotrexate (≥10 mg/week, n = 40), resulted in significant reductions in disease activity at weeks 24 and 48. Sustained improvements in physical function and standard effect sizes (SES) for changes in components of ACR and EULAR criteria were evaluated over 2 yrs.

Results. More patients receiving rituximab + methotrexate completed a 2-yr follow-up without further treatment than those receiving placebo + methotrexate (45% vs 15%, respectively), rituximab alone (10%) or rituximab + cyclophosphamide (22%). This reflected a higher percentage of patients receiving rituximab + methotrexate reporting improvements in Health Assessment Questionnaire Disability Index ≥ minimum clinically important difference at 1 and 2 yrs (68% and 30%, respectively) compared with placebo + methotrexate (28% and 15%), rituximab monotherapy (43% and 10%) or rituximab + cyclophosphamide (39% and 12%). SES were high in all rituximab groups and revealed differing patterns of response over time.

Conclusion. A single course of rituximab with continuing methotrexate in patients with active RA provided clinically meaningful improvements in physical function over 2 yrs, with lower discontinuation rates and larger SES for improvements in ACR and EULAR criteria components.

Keywords: Rituximab; Rheumatoid arthritis; Physical function; Methotrexate; Cyclophosphamide; HAQ-DI; ACR; EULAR.
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