Key clinical point: A premilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.
Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.
Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).
Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.
Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449 .