- Apremilast monotherapy is safe and effective over the long term (52 weeks) in DMARD-naive patients with active psoriatic arthritis (PsA), according to the fourth Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE 4) trial.
Why this matters
- Apremilast is a good treatment option for DMARD-naive patients with psoriatic arthritis.
- Phase 3, randomized, placebo-controlled trial of 527 patients randomly assigned to placebo until week 16 or 24, then rerandomized to apremilast; apremilast 20 mg twice daily; or apremilast 30 mg twice daily.
- Primary outcome was percentage of patients achieving ≥20% improvement in American College of Rheumatology response criteria (ACR20).
- Funding: Celgene Corporation.
- Apremilast patients, at week 16, were more likely to achieve ACR20 response vs placebo patients (placebo, 15.9%; 20-mg group, 28.0% [P=.0062]; 30-mg group, 30.7% [P=.0010]).
- By 52 weeks, 53%-60% of all apremilast groups achieved ACR20 (including placebo rerandomized to apremilast).
- Apremilast patients were less likely to be disabled on the Health Assessment Questionnaire Disability Index at week 16 (placebo, 0.03; 20-mg group, −0.17 [P=.0008]; 30-mg group, −0.21 [P<.0001]).
- Most common apremilast adverse events were mild-to-moderate diarrhea, nausea, headache, and upper respiratory infection.
- Findings may not apply early in disease.