This recombinant IgG1 monoclonal antibody exerts its therapeutic effect through inhibition of human tumor necrosis factor (TNF).
ABBOTTTNF inhibitor approved for psoriatic arthritis
This recombinant IgG1 monoclonal antibody exerts its therapeutic effect through inhibition of human tumor necrosis factor (TNF). Adalimumab was approved on October 3, 2005, for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. The agent can be used alone or in combination with disease-modifying anti-rheumatic drugs (DMARDs).
Efficacy. The safety and efficacy of adalimumab were assessed in 2 randomized, double-blind, placebo-controlled studies in 413 patients with psoriatic arthritis. Study PsA-I enrolled 313 adult patients with moderately-to-severely active psoriatic arthritis (>3 swollen and >3 tender joints) who had an inadequate response to NSAID therapy. Patients received 40 mg of adalimumab or placebo every other week over the course of 24 weeks. Patients on methotrexate (MTX) therapy at enrollment were allowed to continue the drug at the same dose. Compared with placebo, treatment with adalimumab resulted in improvements in the American College of Rheumatology 20%, 50%, and 70% response criteria (ACR20, ACR50, and ACR70, respectively). Patients receiving adalimumab achieved ACR20, ACR50, and ACR70 responses at rates of 57%, 39%, and 23%, respectively, at 24 weeks. This is in comparison to patients receiving placebo, who achieved ACR20, ACR50, and ACR70 responses at rates of 15%, 6%, and 1%, respectively, at 24 weeks (P<.001).
Dosing. The recommended dose of adalimumab for adult patients with psoriatic arthritis is 40 mg administered every other week as a subcutaneous injection. MTX, glucocorticoids, salicylates, NSAIDs, analgesics, or other DMARDs may be continued during treatment with adalimumab. Adalimumab is intended for use under the guidance and supervision of a physician. Patients may self-inject adalimumab if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in injection technique.