RESEARCH - Improvement in patient-reported outcomes in a rituximab trial in patients with severe RA refractory to anti-TNF therapy

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Arthritis Rheum. 2008 Jun 15;59(6):785-93.

Improvement in patient-reported outcomes in a rituximab trial in

patients with severe rheumatoid arthritis refractory to anti-tumor

necrosis factor therapy.

Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak

PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F.

University of Toronto, Toronto, Ontario, Canada.

OBJECTIVE: To assess the effects of treatment with rituximab plus

methotrexate on patient-reported outcomes in patients with active

rheumatoid arthritis (RA) who experienced inadequate response to

anti-tumor necrosis factor therapy. METHODS: Patients with active RA

were randomly assigned to rituximab (1,000 mg on days 1 and 15) or

placebo. The primary end point was the proportion of patients with an

American College of Rheumatology 20% response at week 24. Additional

goals were to assess treatment effects on pain, fatigue, functional

disability, health-related quality of life, and disease activity by

comparing mean changes between groups. The analysis was conducted in

the intent-to-treat population. The proportion of patients who

achieved the minimum clinically important difference on the Health

Assessment Questionnaire (HAQ) disability index (DI), Functional

Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Short

Form 36 (SF-36) was determined. RESULTS: Rituximab patients had

statistically significantly greater pain relief. The FACIT-F showed

significantly greater improvement in rituximab patients than placebo

patients from weeks 12 through 24. Mean improvement from baseline in

functional disability (measured by the HAQ DI) was significantly

greater in rituximab patients from weeks 8 to 24. The mean +/- SD

change from baseline for the SF-36 Physical Component Score was 6.64

+/- 8.74 for rituximab patients and 1.48 +/- 7.32 for placebo patients

(P < 0.0001). The mean change from baseline for the SF-36 Mental

Component Score was 5.32 +/- 12.41 for rituximab patients and 2.25 +/-

12.23 for placebo patients (P = 0.0269).

CONCLUSION: Rituximab produced rapid, clinically meaningful, and

statistically significant improvements in patient-reported pain,

fatigue, functional disability, health-related quality of life, and

disease activity. These effects were sustained throughout the study.

PMID: 18512710

http://www.ncbi.nlm.nih.gov/pubmed/18512710

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