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.
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.


CONCLUSIONS
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.
Strand
Vibeke
V
Division of Immunology, Stanford University School of Medicine, Palo Alto, California, USA.
Scott
David L
DL
Emery
Paul
P
Kalden
Joachim R
JR
Smolen
Josef S
JS
Cannon
Grant W
GW
Tugwell
Peter
P
Crawford
Bruce
B
D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D017326:Clinical Trials, Phase III as Topic; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
D018501:Antirheumatic Agents; D007555:Isoxazoles; D012460:Sulfasalazine; D000077339:Leflunomide; D008727:Methotrexate