OBJECTIVE: To assess the effect of rituximab plus methotrexate (MTX) compared
with MTX alone on patient-reported outcomes (PROs) and health-related quality of
life (HRQOL) in patients with active early rheumatoid arthritis (RA) previously
untreated with MTX.
METHODS: Patients with active early RA were randomized to groups receiving
placebo, rituximab 500 mg, or rituximab 1,000 mg. Rituximab was given by
intravenous infusion on days 1 and 15. From week 24, patients with a Disease
Activity Score in 28 joints-erythrocyte sedimentation rate of ≥2.6 were eligible
for retreatment. Physical function was assessed by Health Assessment
Questionnaire (HAQ) disability index (DI) and Short Form 36 (SF-36) scores.
Patients achieving a minimal clinically important difference (MCID) for PROs were
determined. Additional PROs, including fatigue and pain, were assessed.
RESULTS: A total of 748 patients were randomized and received the study drug.
Patient characteristics were well balanced. At week 52, treatment with rituximab
in both dose groups showed significant improvements in the HAQ DI compared to the
MTX alone group (-0.905 and -0.916 in the rituximab 500 mg plus MTX and 1,000 mg
plus MTX groups, respectively, versus -0.628 in the MTX alone group; P < 0.0001).
Higher proportions of patients achieved MCID in the HAQ DI in the rituximab plus
MTX groups compared to MTX alone. Treatment with rituximab plus MTX led to a
significant reduction in the SF-36 physical component summary for both rituximab
dose groups, but did not show statistically significant differences in the SF-36
mental component summary. Compared to the MTX alone group, both doses of
rituximab plus MTX were associated with significant reductions in the patient
global assessment of disease activity and pain, and a significantly higher
improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores
from baseline to 52 weeks.
CONCLUSIONS: Rituximab plus MTX was associated with significant improvement in
physical function and HRQOL outcomes compared with MTX alone in patients
previously untreated with MTX.
|Numero di pagine||10|
|Rivista||ARTHRITIS CARE AND RESEARCH|
|Stato di pubblicazione||Pubblicato - 2011|
- B cells
- rheumatoid arthritis