An open-label pilot study of apremilast for the treatment of moderate to severe lichen planus: a case series

Abstract

Background: Current treatments for chronic lichen planus (LP) are often ineffective and may have significant adverse side effects. An alternative safe and effective treatment for recalcitrant LP is needed.

Objectives: We sought to study the safety and efficacy of apremilast in the treatment of moderate to severe LP.

Methods: Ten patients with biopsy-proven LP received 20 mg of apremilast orally twice daily for 12 weeks with 4 weeks of treatment-free follow-up. The primary efficacy end point was the proportion of patients achieving a 2-grade or more improvement in the Physician Global Assessment (PGA) after 12 weeks of treatment.

Results: Three (30%) of the 10 patients achieved a 2-grade or more improvement in the PGA after 12 weeks of treatment; however, all patients demonstrated statistically significant clinical improvement with respect to secondary parameters between baseline and the end of treatment.

Limitations: It may be difficult to generalize the results of this study to a larger patient population with LP because of our small sample size and lack of a control group. In addition, a longer treatment period or higher dose may have been needed for therapeutic efficacy. The safety and efficacy of long-term apremilast therapy is currently unknown.

Conclusion: Apremilast may be efficacious in the treatment of LP, but double-blinded, controlled trials are necessary to thoroughly evaluate its safety and efficacy.

Trial registration: ClinicalTrials.gov NCT01041625.