The rheumatoid arthritis (RA) treatment adalimumab (Humira) has received approval for an expanded indication to treat psoriatic arthritis and as a first-line treatment for severe, active, and progressive RA in methotrexate-naive adults. Adalimumab is a product of Abbott Laboratories.

The psoriatic arthritis indication was approved based on the results of clinical studies in 313 patients, which showed that patients treated with the medication achieved a 20% improvement in arthritis signs and symptoms at week 12. The response was sustained through week 24, at which point nearly one-quarter of patients demonstrated a 70% improvement in American College of Rheumatology (ACR) score. Adalimumab-treated patients also had significantly less bone erosion and joint-space narrowing compared with patients taking a placebo.

The new indication for adalimumab as a first-line treatment for RA was based on results of a trial that demonstrated adalimumab treatment plus methotrexate successfully inhibited radiographic progression in patients with recently diagnosed RA (less than 3 years duration). When adalimumab therapy was added to methotrexate treatment, remission rates were nearly doubled at 1 and 2 years compared with methotrexate alone.

Adalimumab was previously approved for reducing signs and symptoms of RA, inhibiting the progression of structural damage, and improving physical function in adults with active, moderate-to-severe RA, who have had inadequate response to disease-modifying antirheumatic drugs, including methotrexate.