Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Combination Therapy with AdalimumabMethotrexate Significantly Improved Work Ability, Physical Function, Fatigue, and Other Patient-Reported Outcomes in Early Rheumatoid Arthritis: Results From a 26-Week Analysis.
Emery1, Paul, Kavanaugh2, Arthur F., Smolen3, Josef, Cifaldi4, Mary A., Chaves4, Leonardo, Guerette5, Benoit, Arora4, Vipin
Leeds Institute of Molecular Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK, Leeds, United Kingdom
University of California San Diego, San Diego, CA
Medical University of Vienna and Hietzing Hospital, Vienna, Austria
Abbott Laboratories, Abbott Park, IL
Abbott, Rungis, France
The Karolinska Institute, Stockholm, Sweden
To compare work ability assessments and other patient-reported outcomes (PROs) in early rheumatoid arthritis (RA) patients treated with adalimumab (ADA)+methotrexate (MTX) vs. MTX+placebo (PBO) over 26 weeks.
OPTIMA (Optimal Protocol for Treatment Initiation With MTX and ADA in Patients With Early RA) was a Phase IV, double-blind, randomized, placebo-controlled trial. The overall study design has been described elsewhere1. This analysis evaluated the Period 1 (26 weeks) PRO, comparing ADA+MTX vs. MTX+PBO. Work outcomes were assessed with the Work Productivity and Activity Impairment (WPAI) questionnaire, percentage of employed patients, and Work Instability Scale (WIS). Other PROs evaluated included: Patient's Global Assessment of disease activity (PaGA; 100-mm visual analog scale (VAS]), Patient Assessment of Pain (PAP; 100-mm VAS), EuroQOL (100-mm VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Patient Assessment Acceptable State (PASS; yes/no). The intent-to-treat population was analyzed and data were imputed using last observation carried forward. For continuous variables, treatment group homogeneity was assessed using 1-way ANOVA. Discrete variables were analyzed using chi-square or Kruskal-Wallis tests.
There were no significant differences between treatment groups with respect to baseline demographics and disease characteristics or baseline PRO assessments, with the exception of employment status. Fewer patients in the ADA+MTX group compared with the MTX+PBO group were employed at baseline (49% vs. 55%; p=0.046). Significant differences between the ADA+MTX and PBO+MTX groups were observed for all PROs as early as Week 4. Improvements were maintained through Week 26. The table summarizes HAQ, PAP, FACIT-F, and WPAI results.
Patient-Reported Outcomes: Change From Baseline to Weeks 4 and 26
|ADA+MTX (N=515)||PBO+MTX (N=517)||P-Value|
|Change at Week 4 (mean±SD)||-0.64±0.61 (n=511)||-0.31±0.54 (n=512)||p<0.001|
|Change at Week 26 (mean±SD)||-0.89±0.74 (n=512)||-0.66±0.73 (n=512)||p<0.001|
|Change at Week 4 (mean±SD)||-28.9±26.15 (n=512)||-15.6±22.70 (n=513)||p<0.001|
|Change at Week 26 (mean±SD)||-37.9±28.61 (n=513)||-28.0±29.33 (n=513)||p<0.001|
|Change at Week 4 (mean±SD)||8.1±10.28 (n=502)||4.4±8.70 (n=508)||p<0.001|
|Change at Week 26 (mean±SD)||10.5±11.82 (n=506)||8.3±11.12 (n=512)||p=0.001|
|WPAI Total Work Productivity Impairment|
|Change at Week 4 (mean±SD)||-13.9±29.39 (n=205)||-5.4±24.32 (n=220)||p<0.001|
|Change at Week 26 (mean±SD)||-23.4±33.1 (n=215)||-16.5±31.20 (n=232)||p=0.002|
Importantly, for those employed at baseline, more patients in the ADA+MTX group compared with the PBO+MTX group were still employed at Week 26 (85.9% vs. 76.3%; p=0.005). No differences were observed at Week 26 between the 2 groups among patients unemployed at baseline.
Patients who received ADA+MTX combination therapy were more likely to remain employed, be less impaired at work, and have less instability for future employment. They were also more satisfied with their health state, were less fatigued, and had better physical functioning than MTX-monotherapy patients. These data suggest that treatment with ADA+MTX for patients with early RA may improve their ability to retain employment and improve daily functionality and overall quality of life.
To cite this abstract, please use the following information:
Emery, Paul, Kavanaugh, Arthur F., Smolen, Josef, Cifaldi, Mary A., Chaves, Leonardo, Guerette, Benoit, et al; Combination Therapy with AdalimumabMethotrexate Significantly Improved Work Ability, Physical Function, Fatigue, and Other Patient-Reported Outcomes in Early Rheumatoid Arthritis: Results From a 26-Week Analysis. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :2189