Patients with psoriatic arthritis had symptom relief after treatment with apremilast compared to placebo, according to the results of the PALACE 3 study.
Researchers studied 505 patients who were randomly assigned 1:1:1 to either 20-mg apremilast (Otezla, Celgene), 30-mg apremilast or placebo twice daily. Patients were stratified by baseline use of disease-modifying anti-rheumatic drugs (DMARDs) and psoriasis involvement based on body surface area. Patients were evaluated for efficacy and safety at weeks 0, 4, 16, 24, 28, 40 and 52.
At week 16, 93% of patients completed the trial, with comparable rates of completion between the treatment groups and placebo group. Significantly more patients who received 20-mg or 30-mg apremilast achieved an ACR20 response rate, with 28% of patients who received 20 mg and 41% of patients who received 30 mg compared to 18% of patients in the placebo group at week 16.
Subgroup analysis revealed a trend toward a higher ACR20 response rate in both treatment arms compared to placebo, both in patients with and without concomitant DMARD use. Higher responses were seen in biologic-naïve patients in the treatment groups.
Significant improvement of Health Assessment Questionnaire–Disability scores was observed in the 30-mg treatment group compared to placebo, with a mean change of -0.20 in the 30-mg treatment group compared to -0.07 in the placebo group. The Psoriasis Area Severity Index 50 score was met by 41% of patients who received the 30-mg doses. The response was numerically higher in the 20-mg group compared with that of the placebo group, but this did not reach statistical significance. Significant reductions in DAS28 were also observed at week 16 in the 30-mg dose group, and both doses were associated with improvements in the mean total joint count. – by Shirley Pulawski
Disclosures: Edwards reports the receipt of research grants and consultant fees from Celgene, Pfizer, Roche and Samsung; and has served on the speakers bureau for Abbott, Glaxo-SmithKline, Pfizer, Bristol-Myers Squibb, Janssen, Novo Nordisk, UCB and Roche. Please see the full study for a list of all other authors’ relevant financial disclosures.