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Health-related Quality of Life Outcomes of Adalimumab for Patients with Early Rheumatoid Arthritis: Results from a Randomized Multicenter Study
- Source :
- The Journal of Rheumatology. 39:63-72
- Publication Year :
- 2011
- Publisher :
- The Journal of Rheumatology, 2011.
-
Abstract
- Objective.Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA.Methods.PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged ≥ 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient’s global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3).Results.Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p Conclusion.Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).
- Subjects :
- Adult
Male
musculoskeletal diseases
medicine.medical_specialty
Visual analogue scale
Immunology
Antibodies, Monoclonal, Humanized
Severity of Illness Index
law.invention
Arthritis, Rheumatoid
Disability Evaluation
Double-Blind Method
Rheumatology
Randomized controlled trial
Quality of life
law
Surveys and Questionnaires
Internal medicine
Severity of illness
medicine
Adalimumab
Humans
Immunology and Allergy
skin and connective tissue diseases
Aged
business.industry
Middle Aged
medicine.disease
humanities
Clinical trial
Methotrexate
Treatment Outcome
Antirheumatic Agents
Rheumatoid arthritis
Quality of Life
Physical therapy
Drug Therapy, Combination
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 14992752 and 0315162X
- Volume :
- 39
- Database :
- OpenAIRE
- Journal :
- The Journal of Rheumatology
- Accession number :
- edsair.doi.dedup.....74f5ae2d128927a3685b8102f7908887