ADALIMUMAB (HUMIRA®) PLUS METHOTREXATE IS SAFE AND EFFICACIOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS INTO THE 7TH YEAR OF THERAPY

Background: In clinical trials, adalimumab, a fully human anti-TNF monoclonal antibody, has been shown to reduce the signs and symptoms and to inhibit radiographic progression of disease in patients with active, moderate to severe rheumatoid arthritis (RA).Objectives: To assess the sustainability of the safety profile and efficacy outcomes of adalimumab 40 mg every other week (eow) plus methotrexate (MTX) in patients with long-standing, moderate to severe RA in two long-term, open-label extension (OLE) studies.Methods: Patients who enrolled in five randomized, controlled trials (RCT) and received adalimumab 40 mg eow plus MTX were evaluated in this analysis. After these trials, patients were eligible to enroll in two separate OLE studies: DE020 (ARMADA, STAR, DE005, DE037) and DE010. Patients were evaluated for efficacy and safety every 3 months.Results: A total of 921 patients received adalimumab 40 mg eow plus MTX and enrolled in the RCTs leading into the DE020 OLE. At the time of this analysis, 617 (66%) patients remain on therapy in the OLE. A total of 304 (33%) patients withdrew: 74 (8%) for lack of efficacy, 106 (11%) for adverse events, and 124 (14%) for other reasons. Eighty-nine patients are into their 5th year of treatment and have demonstrated sustained and consistent clinical improvement over time, as supported by efficacy outcomes and by achievement of clinical remission based on DAS28<2.6. At the last visits of all 921 patients, 23% had 0 tender joints (TJC68), 20% had 0 swollen joints (SJC66), and 42% had a HAQ score ≤0.5–all are parameters of clinical remission.Forty-three patients randomized in the Phase I RCT leading into the DE010 OLE study received adalimumab 40 mg eow plus MTX are included in this analysis. At the time of this evaluation, 31 (72%) patients remain in the OLE and 12 (28%) patients withdrew: 1 (2%) for lack of efficacy, 3 (7%) for adverse events, and 8 (19%) for other reasons. At last visits, 9% had 0 tender joints (TJC68), 23% had 0 swollen joints (SJC66), and 26% had a HAQ score ≤0.5. Sustained response is supported by efficacy outcomes in 15 patients who are into their 7th year of adalimumab therapy. In both OLE trials, adalimumab plus MTX was well-tolerated and rates of adverse events, including serious infections, were consistent with those observed in the RCTs. Long-term Efficacy in Patients Treated with Adalimumab plus MTX Efficacy Criteria DE020 - Year 5 n=89 DE010 - Year 7 n=15 ACR20 (%) 72 87 ACR50 (%) 55 60 ACR70 (%) 38 33 DAS28<2.6 (%) 41 43 DAS28* 2.9 2.7 DAS28 change from baseline* 2.9 3.6 HAQ* 0.5 0.9 HAQ change from baseline* 0.8 0.6 * Median values * Median valuesConclusion: Patients with long-standing RA treated with adalimumab 40 mg eow plus MTX achieved sustained and consistent improvements, into their 7th year of continuous therapy, with more than 40% achieving clinical remission (DAS28<2.6). Long-term adalimumab therapy is safe and well-tolerated.Citation: Ann Rheum Dis, volume 64, supplement III, year 2005, page 438Session: Rheumatoid Arthritis – Treatment