Objectives To evaluate the long-term efficacy and safety of the fully human anti-TNF antibody adalimumab (D2E7) given by the s.c. route to patients with active rheumatoid arthritis.
Methods 24 patients with active rheumatoid arthritis who had previously failed a mean of 3.5 DMARDs were included in this 12-week randomised double blind, placebo-controlled study (DE004), and continued thereafter in an open label part of the study for up to two years on adalimumab. Initially, patients were assigned to either 0.5 mg/kg adalimumab s.c. weekly (18 patients) or placebo (6 patients). 22 patients entered the open-label part of the study: 15 patients who achieved EULAR response continued their previous adalimumab treatment schedule (0.5 mg/kg weekly), 2 patients who did not achieve a EULAR response at week 8 increased their adalimumab dose to 1 mg/kg weekly, and 5 patients previously on placebo received 1 mg/kg adalimumab s.c. weekly.
Patient characteristics at baseline: 60 years mean age, 10 years mean RA duration, 5.35 mean Disease Activity Score (DAS).
Results The overall efficacy results for the open label period of 24 months are summarised in the Table 1 below.
Adverse events were well matched between the adalimumab treatment arm and placebo during the placebo-controlled period. After two years of treatment 14 patients were still receiving study drug. Reasons for drop out were lack of efficacy (4 pts), adverse events (3 pts), death (1 pt on placebo, 1 on adalimumab, both myocardial infarction), and protocol violation (1 pt).
Conclusion Repeated weekly s.c. injections of a dose of 0.5 mg/kg or 1 mg/kg adalimumab (D2E7) given to patients with active rheumatoid arthritis over a period of two years were efficacious and well tolerated.
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