We sought to study the safety and efficacy of apremilast in the treatment of moderate to severe?LP.
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.
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.
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.
Apremilast may be efficacious in the treatment of LP, but double-blinded, controlled trials are necessary to thoroughly evaluate its safety and efficacy.