ADALIMUMAB (HUMIRA®) PLUS METHOTREXATE PROVIDES SUSTAINED IMPROVEMENTS IN PHYSICAL FUNCTION OVER 2 YEARS OF TREATMENT IN PATIENTS WITH RHEUMATOID ARTHRITIS

Background: Rheumatoid arthritis (RA) is a chronic, inflammatory disorder of the joints that produces substantial morbidity, including pain and loss of physical function. Ideal therapies for RA would relieve the signs and symptoms, halt the structural joint damage, and provide sustained improvement in physical function.Objectives: To evaluate the ability of adalimumab 40 mg every other week (eow) sc plus methotrexate (MTX) to maintain improved physical function in patients with moderate to severe RA.Methods: This study (DE019 OLE) was a multicenter, open-label, extension study of patients with RA receiving adalimumab plus concomitant MTX who had completed the double-blind, placebo-controlled, 52-week lead-in study. In the second year, all patients received adalimumab 40 mg eow sc plus MTX and were evaluated for safety and efficacy at regularly scheduled intervals. Physical function was assessed using the Disability Index of the Health Assessment Questionnaire (HAQ DI), which measures the patient's ability to dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity. Endpoints assessed included the proportion of patients achieving a 0.5 unit or greater improvement in HAQ DI at week 52 that was maintained at week 104.Results: A total of 457 patients were treated in DE019 OLE at 83 sites in the US and Canada. Of these, 91% (415) completed the OLE. Reasons for withdrawal included adverse events (19), lack of efficacy and/or progression of disease (8), lost to follow-up (4) and other (11). Baseline demographics and disease severity characteristics of those patients continuing in the second year were similar to the original population enrolling in the blinded phase. For patients who received adalimumab in year 1 of the study, 82% of HAQ DI 0.50 responders remained 0.50 responders at week 104. Patients that had achieved ACR20, 50 and 70 responses in the first year also maintained their responses in the second year. The number (%) of patients that achieved an ACR20 was 216 (67%) and 200 (62%) in the first and second year, respectively; ACR50 responses were 161 (50%) and 142 (44%) and ACR70 responses were 85 (26%) and 92 (28%), respectively. Response rates for the other outcome measures followed similar trends.Conclusion: Improvement in physical function is sustained over 2 years of treatment with adalimumab plus MTX in patients with established rheumatoid arthritis. Responses to treatment with adalimumab were substantial, and were maintained over the course of therapy.Citation: , volume , supplement , year 2004, page Session: Rheumatoid arthritis – Treatment