Evaluation of the Efficacy and Safety of Apremilast in the Management of Lichen Planus

Abstract

Introduction

Lichen planus is a chronic disease with often disappointing and less than optimal treatment options. Apremilast modulates inflammatory signalling pathways which play a central role in the pathogenesis of lichen planus, thus making it useful in the management of such patients.

Materials and Methods

The present study was an investigator-initiated, single-centre, non-randomized, open-label, pilot study of the efficacy and safety of Apremilast in the treatment of lichen planus. All the patients were prescribed Apremilast 30mg, twice daily, for 12 weeks. Patients were evaluated for improvement in their lesions, based on the physician’s global assessment (PGA), subject global assessment (SGA), and target area lesion symptom score (TALSS).

Results

A total of 34 patients were included in the study; 26 patients completed the study duration and were considered for the final analysis. After 12 weeks, 34.61% (n = 9/26) patients showed 2 or more grade improvement in their disease as per PGA. About 42.30% (n = 11/26) patients achieved more than 50% improvement in their lesions based on the subject global assessment of their disease. There was a significant improvement in TALSS during the study period (p < 0.0001). Only 23.07% (n = 6/26) patients developed one or more adverse events because of Apremilast with headache being the commonest side effect.

Conclusion

The results obtained in our study justify that Apremilast is efficacious and safe in the management of patients with lichen planus. Based on these results, Apremilast can be considered as a promising alternative treatment option in patients with lichen planus.

Keywords:

• Apremilast
• lichen planus
• efficacy
• safety

Data Sharing Statement

The datasets are available only on request due to privacy/ethical restrictions and can be requested from [email protected].

Acknowledgment

Authors would like to acknowledge the medical team of Glenmark Pharmaceuticals Ltd for compiling all data and its analysis and manuscript preparation.

Disclosure

Dr Dhiraj Dhoot, Dr Namrata Mahadkar and Dr Hanmant Barkate are employees of Glenmark Pharmaceuticals Ltd, India. The other authors declare no conflicts of interest in this work.

Additional information

Funding

No funding was received for this clinical study, but drugs were supplied by Glenmark Pharmaceuticals Ltd, Mumbai for conduct of this study.