Publication:

An open label randomized placebo-controlled study of apremilast in common immune mediated papulosquamous hair and pigmentary dermatoses

Background Apremilast is a novel PDE4 inhibitor which interferes with several key processes of inflammation. The objective of this study was to determine the efficacy and safety profile of apremilast in common immune mediated papulosquamous, hair and pigmentary dermatoses.

Methods It was a prospective, open labelled, randomised, placebo-controlled study done over a period of 18 months. A total number of 100 patients were enrolled in which 50 were cases and 50 were controls. Psoriasis, lichen planus, alopecia areata and vitiligo cases were randomly enrolled at our OPD. Apremilast starter pack was given initially for 1 week followed by 30 mg twice daily for four months. All patients were followed up every 4 weeks for 16 weeks. Photographic documentation, assessment of PASI, LPSI, SALT, VASI and adverse effects were noted at baseline and at each visit. Patients were followed up for 6 months after the treatment for any recurrences.

Results Mean percentage improvement of PASI score in psoriasis group, LPSI score in LP group, SALT score in alopecia areata group and VASI score in vitiligo group was 62%, 71%, 24.4% and 15% respectively. Apremilast was more effective in psoriasis and lichen planus groups.

Conclusions Apremilast is an effective treatment option for mild to moderate psoriasis and lichen planus but was found to be less efficacious in alopecia areata and vitiligo, according to our study. Apremilast was well tolerated with minimal side effects which were manageable with symptomatic treatment.