Function and health-related quality of life - Results from a randomized controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis

Objective. To assess the efficacy of leflunomide or methotrexate compared w ith placebo in improving function and health-related quality of life in pat ients with active rheumatoid arthritis (RA), and to examine correlations be tween response status las defined by the American College of Rheumatology [ ACR] response criteria) and improvement in these measures. Methods. This 52-week, multicenter, double-blind, controlled trial compared responses to the Health Assessment Questionnaire (HAQ), modified Health As sessment Questionnaire (MHAQ), Problem Elicitation Technique (PET), Medical Outcomes Study Short Form 36 (SF-36), and questions regarding work product ivity among 3 treatment groups (leflunomide, methotrexate, and placebo). Im provement in the PET top 5 and SF-36 scales and component scores were compa red with ACR response rates. Results. Clinically meaningful and statistically significant (P < 0.0001) i mprovement in measures of function and heath-related quality of life (MHAQ scores, all scales and disability index of the HAQ, weighted top 5 score of the PET, 5 of 8 scales and physical component score of the SF-36, and work productivity) was seen during treatment,vith leflunomide in comparison wit h placebo. Methotrexate administration resulted in significant improvements (P < 0.05) in comparison with placebo in the MHAQ scores, HAQ disability i ndex, weighted top 5 score of the PET, physical component score of the SF-3 6, and bodily pain scale, Compared with methotrexate, leflunomide administr ation resulted in significantly (P < 0.01) more improvement in the MHAQ sco res, 5 of 8 scales and disability index of the HAQ, weighted top 5 score of the PET, and 2 of 8 scales and physical component score of the SF-36. Impr ovements in the PET score, SF-36 physical component score, and work product ivity correlated with the ACR responder rates of greater than or equal to 2 0% and greater than or equal to 50% improvement. Conclusion. Significant improvements in function and health-related quality of life occurred in patients with RA during treatment with leflunomide or methotrexate, These findings were clinically meaningful and correlated with the ACR response status.