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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
VIBEKE STRAND, DAVID L. SCOTT, PAUL EMERY, JOACHIM R. KALDEN, JOSEF S. SMOLEN, and GRANT W. CANNON, for the Leflunomide Rheumatoid Arthritis Investigators Groups, PETER TUGWELL, and BRUCE CRAWFORD
ABSTRACT.
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. (J Rheumatol 2005;32:590-601) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Division of Immunology, Stanford University School of Medicine, Palo Alto, California, USA; Department of Rheumatology, Dulwich Hospital, London, UK; Department of Rheumatology and Rehabilitation, University of Leeds School of Medicine, Leeds, UK; Medizinische Klinik III Mit Poliklinik, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Germany; Center for Rheumatic Diseases at Lainz Hospital, Vienna, Austria; Veterans Affairs Medical Center and University of Utah, Salt Lake City, Utah, USA; Ottawa Hospital, Ottawa, Ontario, Canada; and Mapi Values, Boston, Massachusetts, USA. These clinical trials were funded by Aventis Pharmaceuticals, Bridgewater, NJ, USA. V. Strand, MD, Adjunct Clinical Professor, Division of Immunology, Stanford University School of Medicine; D. Scott, MD, Professor of Clinical Rheumatology, Department of Rheumatology, Dulwich Hospital; P. Emery, MD, Department of Rheumatology and Rehabilitation, University of Leeds School of Medicine; J. Kalden, MD, Medizinische Klinik III Mit Poliklinik, Friedrich-Alexander-Universitat Erlangen-Nurnberg; J. Smolen, MD, Center for Rheumatic Diseases at Lainz Hospital; G. Cannon, MD, Veterans Affairs Medical Center and University of Utah; P. Tugwell, MD, Head, Department of Medicine, Ottawa Hospital; B. Crawford, MA, MPH, Director, Patient Reported Outcomes and Regulatory Consulting, Mapi Values. Address reprint requests to B. Crawford, Mapi Values, 15 Court Square, Suite 620, Boston, MA 02108. E-mail: bruce.crawford@mapivaluesusa.com Submitted March 4, 2004; revision accepted October 29, 2004. |