Improved Health-Related Quality of Life for Patients with Active Rheumatoid Arthritis Receiving Rituximab — Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial

PHILIP J. MEASE, DENNIS A. REVICKI, JACEK SZECHINSKI, MARIA GREENWALD, ALAN KIVITZ, LEONOR BARILE-FABRIS, JATINDERPAL KALSI, JENNIFER EAMES, and MARJATTA LEIRISALO-REPO

ABSTRACT.

Objective. To evaluate the effect of rituximab treatment on health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA), who have had an inadequate response to disease-modifying antirheumatic drugs, including biologic agents.

Methods. A randomized, multicenter, double-blind, placebo-controlled clinical trial involving 367 rheumatoid factor-positive patients was conducted. Patients received 2 infusions 2 weeks apart of placebo (n = 122), rituximab 500 mg (n = 123), or rituximab 1000 mg (n = 122), with or without glucocorticoids. All patients received stable doses of methotrexate (10–25 mg/wk). Measures included SF-36, assessed at baseline and at 24 weeks, as well as the HAQ and FACIT-Fatigue scale assessed at baseline and monthly for 24 weeks. Patients exceeding prespecified minimal clinically important differences (MCID) were examined. Clinical efficacy measurements (ACR20/50/70 and EULAR responses) were compared with HRQOL outcomes.

Results. At 24 weeks, the rituximab 500 mg and 1000 mg groups both reported statistically significantly greater improvements on the SF-36 physical component summary (4.37 and 4.89 points higher, respectively, vs placebo; p < 0.001). SF-36 physical function, bodily pain, vitality, social function, and role-physical subscale scores also statistically significantly improved vs placebo. At 24 weeks, 62.6% and 67.2% of the rituximab 500 mg and 1000 mg groups, respectively, exceeded the MCID of 0.22 in HAQ (p < 0.001). For FACIT-Fatigue, 55.3% and 65.6% of patients exceeded the MCID of 3.5 points compared with 35.2% of placebo over 24 weeks (p < 0.001). ACR20/50/70 and EULAR responders demonstrated greater improvements in mean baseline to 24 week changes in SF-36 and FACIT-Fatigue scores compared with nonresponders (p < 0.05).

Conclusion. Both rituximab doses in combination with methotrexate were effective in improving all HRQOL outcomes in patients with active RA consistent with clinical efficacy. (First Release Nov 15 2007; J Rheumatol 2008;35:20-30)

Key Indexing Terms:

RITUXIMAB
METHOTREXATE
PHYSICAL FUNCTION
RHEUMATOID ARTHRITIS
HEALTH-RELATED QUALITY OF LIFE
PATIENT-REPORTED OUTCOME

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From Seattle Rheumatology Associates, Seattle, WA; United BioSource Corporation, Center for Health Outcomes Research, Bethesda, MD, USA; Medical University of Wroclaw, Wroclaw, Poland; Desert Medical Advances, Palm Desert, CA; Altoona Center for Clinical Research, Duncansville, PA, USA; Hospital Angeles, Mexico City, Mexico; Roche Products Ltd., Welwyn Garden City, UK; Genentech, Inc., South San Francisco, CA, USA; and Helsinki University Central Hospital, Helsinki, Finland.

Supported by Genentech, Inc.

P.J. Mease, MD, Seattle Rheumatology Associates; D.A. Revicki, PhD, United BioSource Corporation, Center for Health Outcomes Research; J. Szechinski, MD, Medical University of Wroclaw; M. Greenwald, MD, Desert Medical Advances; A. Kivitz, MD, Altoona Center for Clinical Research; L. Barile-Fabris, MD, Hospital Angeles; J. Kalsi, MD, Roche Products Ltd.; J. Eames, MPH, Genentech, Inc; M. Leirisalo-Repo, MD, PhD, Helsinki University Central Hospital.

Address reprint requests to Dr. P.J. Mease, Seattle Rheumatology Associates, 1101 Madison Street, Suite 1000, Seattle, WA 98104. E-mail: pmease@nwlink.com

Accepted for publication July 3, 2007.

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