Psoriatic arthritis patients improved symptoms with oral apremilast

WASHINGTON — Patients with psoriatic arthritis, who had unsuccessful treatment with disease-modifying antirheumatic drugs including biologics, had significant improvement after being assigned oral apremilast, according to data presented at the American College of Rheumatology Annual Meeting.

Researchers evaluated patients as part of the PALACE 1 study, the first of three phase 3 placebo-controlled trials evaluating apremilast (Celgene), a novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4). The drug was assigned to patients with psoriatic arthritis (PsA) who previously experienced poor response from disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent, according to a Celgene press release. Treatment with apremilast was monotherapy or combined with oral DMARD.

At week 16, apremilast had statistically significant and higher ACR20 responses in patients receiving either 20 mg daily or 30 mg daily monotherapy (31.5% and 50.8%, respectively) compared with placebo (10.5%) (P<.05 and P<.0001, respectively), Celgene reported.

Statistically significant changes in reducing signs and symptoms of PsA, as measured by the primary endpoint of week 16, were achieved by patients receiving treatment of apremilast 30 mg twice a day compared with placebo (41.0% vs. 19.4%; P≤.0001). Arthritis-related secondary endpoints, including ACR50, ACR70, DAS-28, good or moderate EULAR response achievement and CDAI at week 24, showed consistent response.

Apremilast was generally well tolerated; adverse events (diarrhea, nausea, headache and upper respiratory tract infection) were considered mild or moderate in more than 95% of cases, according to study data.

“The results of this first phase 3 trial are encouraging for both physicians and patients as a potentially effective and safe oral therapy for psoriatic arthritis patients,” researcher Arthur F. Kavanaugh, MD, professor of clinical medicine at University of California, San Diego, said in the news release. Kavanaugh presented the study today at the ACR annual meeting.

Disclosure: Kavanaugh and other researchers reported numerous financial disclosures.

For more information:

Kavanaugh AF. L13. Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results of a Phase 3, Randomized, Controlled Trial. Presented at: American College of Rheumatology 2012 Annual Meeting; Nov. 10-14, Washington.