Objectives To evaluate the long-term efficacy and safety of a combination of methotrexate (MTX) with the fully human anti-TNF antibody adalimumab (D2E7) in patients with active rheumatoid arthritis (RA).

Methods 54 patients, who were partial responders to standard doses of MTX (mean 16 mg/week), were included in this randomised double blind, placebo-controlled study (DE010). Initially, patients were randomised into three treatment arms of 18 patients each and then injected double blind (first and second injection) with either 1 mg/kg adalimumab i.v., 1 mg/kg adalimumab s.c., or placebo (double dummy). Thereafter, all patients received open-label s.c. injections of 1 mg/kg adalimumab. The frequency of administration (every other week up to every other month) depended on the individual response to treatment.

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 both adalimumab treatment arms and placebo during the initial double blind study period. A total of 44 patients (81%) were able to complete the 2-year study period. Reasons for drop out were adverse events (6 pts), lack of efficacy (2 pts), death (1 pt, myocardial infarction), and protocol violation (1 pt).

Conclusion Repeated subcutaneous injections of 1 mg/kg adalimumab (D2E7) over a period of two years showed sustained efficacy and were well tolerated when given in combination with stable standard doses of MTX to patients with active RA.