PMID- 15801012 OWN - NLM STAT- MEDLINE DCOM- 20050711 LR - 20181201 IS - 0315-162X (Print) IS - 0315-162X (Linking) VI - 32 IP - 4 DP - 2005 Apr TI - Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. PG - 590-601 AB - OBJECTIVE: To determine whether improvements in physical function and health related quality of life (HRQOL) are sustained over 2 years of blinded treatment with leflunomide (LEF), methotrexate (MTX), or sulfasalazine (SSZ) in patients with active rheumatoid arthritis (RA). METHODS: Three phase III randomized, controlled trials compared LEF, MTX, and SSZ in patients with active RA. Improvements in physical function were assessed by Health Assessment Questionnaire Disability Index (HAQ-DI) and Modified Health Assessment Questionnaire (MHAQ); monthly MHAQ and mean HAQ scores were used to calculate American College of Rheumatology responses; HAQ-DI was assessed at baseline and 6-month intervals. In US301, the Medical Outcomes Study 36-Item Short-Form questionnaire (SF-36) assessed treatment-associated changes in HRQOL at baseline and 6-month intervals. RESULTS: Mean and median improvements in HAQ-DI after 12 and 24 months of active treatment in all phase III protocols significantly exceeded -0.22 or a minimum clinically important difference (MCID). These improvements closely reflected positive changes in SF-36 that met or exceeded MCID in all domains with LEF and MTX treatment. Problem Elicitation Technique Top 5 scores reflected improvements in performance of physical activities most important to patients. CONCLUSION: Improvements in physical function were sustained over 24 months of successful treatment with LEF, MTX, and SSZ, and reflected improvements in mental as well as physical domains of HRQOL. FAU - Strand, Vibeke AU - Strand V AD - Division of Immunology, Stanford University School of Medicine, Palo Alto, California, USA. FAU - Scott, David L AU - Scott DL FAU - Emery, Paul AU - Emery P FAU - Kalden, Joachim R AU - Kalden JR FAU - Smolen, Josef S AU - Smolen JS FAU - Cannon, Grant W AU - Cannon GW FAU - Tugwell, Peter AU - Tugwell P FAU - Crawford, Bruce AU - Crawford B CN - Leflunomide Rheumatoid Arthritis Investigators Groups LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - Canada TA - J Rheumatol JT - The Journal of rheumatology JID - 7501984 RN - 0 (Antirheumatic Agents) RN - 0 (Isoxazoles) RN - 3XC8GUZ6CB (Sulfasalazine) RN - G162GK9U4W (Leflunomide) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM CIN - J Rheumatol. 2005 Apr;32(4):575-7. PMID: 15801008 MH - Antirheumatic Agents/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy/pathology/physiopathology MH - Clinical Trials, Phase III as Topic MH - Disability Evaluation MH - Double-Blind Method MH - Female MH - *Health Status MH - Humans MH - Isoxazoles/*therapeutic use MH - Leflunomide MH - Male MH - Methotrexate/*therapeutic use MH - Middle Aged MH - Prospective Studies MH - *Quality of Life MH - Randomized Controlled Trials as Topic MH - Severity of Illness Index MH - Sulfasalazine/*therapeutic use MH - Surveys and Questionnaires EDAT- 2005/04/01 09:00 MHDA- 2005/07/12 09:00 CRDT- 2005/04/01 09:00 PHST- 2005/04/01 09:00 [pubmed] PHST- 2005/07/12 09:00 [medline] PHST- 2005/04/01 09:00 [entrez] AID - 0315162X-32-590 [pii] PST - ppublish SO - J Rheumatol. 2005 Apr;32(4):590-601.