This article is more than 5 years old. Information may no longer be current.

Psoriatic arthritis patients achieved ACR20 with apremilast up to 1 year

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

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.