RESEARCH - Sustained benefit in RA following one course of Rituxan (rituximab): improvements over 2 years

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Rheumatology Advance Access originally published online on October 24, 2006

Rheumatology 2006 45(12):1505-1513; doi:10.1093/rheumatology/kel358

Sustained benefit in rheumatoid arthritis following one course of rituximab:

improvements in physical function over 2 years

V. Strand, A. Balbir-Gurman1, K. Pavelka2, P. Emery3, N. Li4, M. Yin4, P. B.

Lehane5 and S. Agarwal4

Division of Immunology, Stanford University, Palo Alto, CA, USA, 1B. Shine

Department of Rheumatology, Rambam Medical Center, Haifa, Israel, 2Institute

of Rheumatology, Prague University, Prague, Czech Republic, 3Department of

Rheumatology, University of Leeds, Leeds, UK, 4Biostatistics and Clinical

Science, Genentech, Inc., South San Francisco, CA, USA and 5Clinical

Science, Roche Products Ltd, Welwyn Garden City, UK.

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.

Full text here:

http://rheumatology.oxfordjournals.org/cgi/content/full/45/12/1505

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