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

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.