A phase IIb single-center study to assess the efficacy of apremilast for the treatment of nummular eczema.

Abstract

Background: The pathogenesis of nummular eczema (NE) remains unclear, and no targeted therapy has been approved. Apremilast is a small molecule inhibitor targeting phosphodiesterase-4.

Patients and methods: A phase IIb randomized, double-blind, placebo-controlled study evaluating the effects of apremilast or placebo in patients with NE. Patients received apremilast (30 mg BID) or placebo until week 16 followed by an open label phase in which all patients were treated with apremilast until week 32. The primary endpoint was the number of patients achieving an improvement in Physician's Global Assessment (PGA) by two or more points or an absolute PGA of 0 or 1 at week 16. Secondary endpoints included changes in skin physiology, life quality, or dermato-pathology.

Results: 33 patients were enrolled, of whom 31 were randomized to apremilast (n  =  15) or placebo (n  =  16). 1/15 (6.7%) patients in the apremilast group and 4/16 (25.0%) in the placebo group reached the primary endpoint (p  =  0.369). There was no difference between placebo and apremilast with regard to all secondary endpoints at week 16 and week 32. The safety profile was in accordance with the known safety profile of apremilast.

Conclusion: Phosphodiesterase-4 inhibition by apremilast showed no beneficial effects for the treatment of NE.