Psoriatic arthritis patients achieved ACR20 with apremilast up to 1 year

SAN DIEGO — Patients with psoriatic arthritis who were naive to disease-modifying antirheumatic drugs displayed clinical improvements in signs and symptoms during treatment up to 1 year with apremilast, according to research presented at the American College of Rheumatology annual meeting.

“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naive psoriatic arthritis patients,” researcher Alvin Wells, MD, PhD, director of the Rheumatology and Immunotherapy Center, Franklin, Wis., said in a press release.

In a stage 3 controlled trial (PALACE 4), researchers studied 527 patients with psoriatic arthritis (PsA; mean age, 49.4 years; 52.6% women) and had a history of psoriasis who were disease-modifying antirheumatic drug (DMARD)-naive. Patients were randomly assigned placebo (PBO), 20 mg apremilast (APR20) twice daily or 30 mg apremilast (APR30) twice daily. Patients who had less than 20% reduction from baseline in swollen joint count (SJC) or tender joint count (TJC) qualified for “protocol-required early escape,” with PBO patients randomly reassigned APR20 or APR30. All remaining PBO patients were randomly reassigned APR20 or APR30 at weeks 26 through 52.

At baseline, patients had a mean SJC of 11.2, mean tender joint count TJC of 20.1 and mean HAQ-DI of 1.068. Enthesitis and dactylitis were experienced by 65% and 50% of patients, respectively, and 73.1% of patients used nonsteroidal anti-inflammatory drugs at baseline.

The per-protocol population included 501 patients. At week 16, 29.9% of APR20 patients and 32.3% of APR30 patients achieved ACR20, compared with 16.9% of PBO patients (P=.0076 and P=.0011 vs. PBO, respectively). Fifty-three percent of APR20 patients and 59% of APR30 patients achieved ACR20 at 1 year from baseline. ACR50 was achieved by 27% of APR20 patients and 32% of APR30 patients, while ACR70 was met by 14% of APR20 patients and 18% of APR30 patients at 52 weeks.

Adverse events (AE) were comparable over the PBO-controlled period through 1 year. AEs occurring in at least 5% of APR-treated patients included nausea, diarrhea, headache and upper respiratory tract infection. Serious AEs were experienced by 2.8%, 1.7% and 0.6% of PBO, APR20 APR30 patients, respectively, during the same period. Four serious infections were reported.

“These encouraging results suggest that apremilast may have the potential to be used alone or as a first-line therapy,” Wells said.

Disclosure: See the abstract for a full list of relevant financial disclosures.

For more information:

Wells AF. #L4: Apremilast in the Treatment of DMARD-Naive Psoriatic Arthritis Patients: Results of a Phase 3 Randomized, Controlled Trial (PALACE 4). Presented at: the 2013 American College of Rheumatology Annual Meeting; Oct. 26-30, San Diego.