Apremilast proven safe, effective in mild to moderate psoriasis

Treatment with apremilast appears safe and effective against mild to moderate plaque psoriasis, according to a recent study.

A team of investigators conducted this phase III, double-blind, placebo-controlled study to assess apremilast 30 mg twice daily in adults with mild to moderate psoriasis who were inadequately controlled or intolerant to at least one topical psoriasis 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 outcome.

A total of 595 patients were randomly assigned to receive either apremilast (n=297) or placebo (n=298). The primary outcome was achieved, with a significantly higher static PGA response rate seen at week 16 in the apremilast group than the placebo group (21.6 percent vs 4.1 percent; p<0.0001).

Patients also met the other outcomes, with the achievement of 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 PGA 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).

Consistent with other studies, the most common adverse events (≥5 percent) reported with apremilast were as follows: diarrhoea, headache, nausea, nasopharyngitis, and upper respiratory tract infection.

This study was limited by the lack of an active-comparator arm, according to the investigators.