OBJECTIVE: To assess the efficacy of leflunomide or methotrexate compared with placebo in improving function and health-related quality of life in patients with active rheumatoid arthritis (RA), and to examine correlations between response status (as defined by the American College of Rheumatology [ACR] response criteria) and improvement in these measures. METHODS: This 52-week, multicenter, doubleblind, controlled trial compared responses to the Health Assessment Questionnaire (HAQ), modified Health Assessment Questionnaire (MHAQ), Problem Elicitation Technique (PET), Medical Outcomes Study Short Form 36 (SF-36), and questions regarding work productivity among 3 treatment groups (leflunomide, methotrexate, and placebo). Improvement in the PET top 5 and SF-36 scales and component scores were compared with ACR response rates. RESULTS: Clinically meaningful and statistically significant (P<0.0001) improvement 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 with leflunomide in comparison with placebo. Methotrexate administration resulted in significant improvements (P<0.05) in comparison with placebo in the MHAQ scores, HAQ disability index, weighted top 5 score of the PET, physical component score of the SF-36, and bodily pain scale. Compared with methotrexate, leflunomide administration resulted in significantly (P<0.01) more improvement in the MHAQ scores, 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. Improvements in the PET score, SF-36 physical component score, and work productivity correlated with the ACR responder rates of > or =20% and > or =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.
RCT Entities:
OBJECTIVE: To assess the efficacy of leflunomide or methotrexate compared with placebo in improving function and health-related quality of life in patients with active rheumatoid arthritis (RA), and to examine correlations between response status (as defined by the American College of Rheumatology [ACR] response criteria) and improvement in these measures. METHODS: This 52-week, multicenter, doubleblind, controlled trial compared responses to the Health Assessment Questionnaire (HAQ), modified Health Assessment Questionnaire (MHAQ), Problem Elicitation Technique (PET), Medical Outcomes Study Short Form 36 (SF-36), and questions regarding work productivity among 3 treatment groups (leflunomide, methotrexate, and placebo). Improvement in the PET top 5 and SF-36 scales and component scores were compared with ACR response rates. RESULTS: Clinically meaningful and statistically significant (P<0.0001) improvement 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 with leflunomide in comparison with placebo. Methotrexate administration resulted in significant improvements (P<0.05) in comparison with placebo in the MHAQ scores, HAQ disability index, weighted top 5 score of the PET, physical component score of the SF-36, and bodily pain scale. Compared with methotrexate, leflunomide administration resulted in significantly (P<0.01) more improvement in the MHAQ scores, 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. Improvements in the PET score, SF-36 physical component score, and work productivity correlated with the ACR responder rates of > or =20% and > or =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.
Authors: Peter K Schädlich; Henning Zeidler; Angela Zink; Erika Gromnica-Ihle; Matthias Schneider; Christoph Straub; Josef G Brecht; Eduard Huppertz Journal: Pharmacoeconomics Date: 2005 Impact factor: 4.981
Authors: Arnold E Postlethwaite; Weng Kee Wong; Philip Clements; Soumya Chatterjee; Barri J Fessler; Andrew H Kang; Joseph Korn; Maureen Mayes; Peter A Merkel; Jerry A Molitor; Larry Moreland; Naomi Rothfield; Robert W Simms; Edwin A Smith; Robert Spiera; Virginia Steen; Kenneth Warrington; Barbara White; Frederick Wigley; Daniel E Furst Journal: Arthritis Rheum Date: 2008-06
Authors: A S Russell; G V Wallenstein; T Li; M C Martin; R Maclean; B Blaisdell; K Gajria; J C Cole; J-C Becker; P Emery Journal: Ann Rheum Dis Date: 2006-09-19 Impact factor: 19.103
Authors: Peter K Schädlich; Henning Zeidler; Angela Zink; Erika Gromnica-Ihle; Matthias Schneider; Christoph Straub; Josef G Brecht; Eduard Huppertz Journal: Pharmacoeconomics Date: 2005 Impact factor: 4.981
Authors: Maria Angeles Lopez-Olivo; Harish R Siddhanamatha; Beverley Shea; Peter Tugwell; George A Wells; Maria E Suarez-Almazor Journal: Cochrane Database Syst Rev Date: 2014-06-10