Efficacy and Safety of Apremilast Over 52 Weeks in Patients with Plaque Psoriasis in High-Impact Areas and Impaired Quality of Life.

INTRODUCTION

In EMBRACE, significant benefits were seen with apremilast versus placebo on quality of life (QoL) and clinical outcomes after 16 weeks in patients with chronic plaque psoriasis in ≥ 1 high-impact area, limited skin involvement, and impaired QoL, in a European population previously unstudied with apremilast. Our objective was to evaluate the 52-week efficacy and safety of apremilast.

METHODS

EMBRACE was a phase 4, multicenter, randomized, placebo-controlled, double-blind study. Eligible patients had chronic plaque psoriasis for ≥ 6 months prior to baseline; involvement in ≥ 1 high-impact area; a Psoriasis Area and Severity Index score ≥ 3 to ≤ 10; and a Dermatology Life Quality Index score > 10. Patients were randomized (2:1) to receive apremilast 30 mg twice daily or placebo from weeks 0 to 16; after that, all patients continued with apremilast (apremilast/apremilast) or switched from placebo to apremilast (placebo/apremilast) until week 52.

RESULTS

Of 277 patients randomized (apremilast: 185, placebo: 92), 158 (apremilast/apremilast: 105; placebo/apremilast: 53) completed 52 weeks. Improvements in QoL, itch, skin discomfort/pain, patient-reported treatment benefits, and skin outcomes at week 16 were maintained over 52 weeks in patients continuing apremilast treatment. Similar improvements were seen at week 52 in patients who switched from placebo to apremilast at week 16. No new safety signals were observed.

CONCLUSIONS

Improvements in QoL and disease severity at week 16 were maintained through week 52 with continued apremilast treatment in EMBRACE, with no new safety signals. TRIAL REGISTRATION CLINICALTRIALS.

GOV IDENTIFIER

NCT03774875.