Apremilast safe, effective in mild-to-moderate psoriasis

Treatment with apremilast is effective in mild-to-moderate plaque psoriasis and has a consistent safety profile, results of a phase III study have shown.

The investigators evaluated the safety and efficacy of apremilast in this phase III, double-blind, placebo-controlled randomized trial of adults with mild-to-moderate psoriasis inadequately controlled or intolerant to at least one topical therapy. The achievement of static Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and ≥2-point reduction at week 16 was the primary endpoint.

A total of 595 patients were randomly assigned to receive apremilast 30 mg twice daily (n=297) or placebo (n=298). Participants achieved the primary endpoint, with significantly greater static PGA response rate at week 16 in the apremilast group compared with the placebo group (21.6 percent vs 4.1 percent; p<0.0001).

Individuals on apremilast also achieved better rates in other endpoints: body surface area (BSA)-75 (33.0 percent vs 7.4 percent), BSA ≤3 percent (61.0 percent vs 22.9 percent), ≥4-point reduction in Whole Body Itch Numeric Rating Scale (43.2 percent vs 18.6 percent), Scalp Physician Global Assessment 0 or 1 and ≥2-point reduction (44.0 percent vs 16.6 percent), and changes from baseline in BSA, Psoriasis Area and Severity Index, and Dermatology Life Quality Index (p<0.0001 for all).

Adverse events that occurred frequently (≥5 percent) with apremilast were diarrhoea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, which were consistent with earlier studies.

The present study was limited by its lack of an active comparator arm, according to the investigators.