Baricitinib in the Treatment of Frontal Fibrosing Alopecia: Mid Trial Update

Abstract

Background  Frontal fibrosing alopecia (FFA) is an inflammatory cicatricial alopecia that results in permanent loss of the frontotemporal hairline and brows. This condition mostly impacts post-menopausal women and is thought to be a variant of lichen planopilaris (LPP). The incidence of FFA is unknown but is increasing. Treatments with conventional topical and systemic therapies have been unsuccessful at halting disease progression in most cases. Several publications have demonstrated JAK/STAT as a potential treatment target in FFA and similar conditions. In this proof-of-concept study, the objective is to assess the efficacy of baricitinib on stopping disease activity and progression of frontal fibrosing alopecia.

Methods  This study is a 36 week open label study in females >/= 18 years of age with biopsy proven frontal fibrosing alopecia. Endpoints include assessments at weeks 12, 24, and 36.  Week 12 analysis evaluated improvement in Lichen Planopilaris Activity Index (LPPAI).  Subjects were treated with 4 mg daily of baricitinib as monotherapy from week 0 to week 12.  All subjects proceeded with subsequent visits.

Results  Twenty total patients were screened. Five patients screen failed. At time of analysis,13 participants had completed week 12 visit. The patients were all post-menopausal women with biopsy proven FFA and had failed multiple prior therapies. From screening to week 12 the average LPPAI for all the participants decreased from 6.18 to 2.26 (-3.92) which was statistically significant (p<0.05). The patient reported outcome for scalp hair growth (PRO Scalp) increased from 0.85 to 2.38 (+1.54) on average during the same time (p<0.05). The patient reported outcome for eyebrow growth (PRO eyebrow) showed no difference during this time. The visual analogue scale (VAS) pruritis score decreased on average from 4.38 to 3.46 (-0.92) but this was not statistically significant (p>0.05).

Conclusion  After 12 weeks of therapy, baricitinib shows potential as an effective monotherapy for FFA. While patient perception of eyebrow growth did not change, perception of scalp growth improved as well as symptoms of itch. Clinical improvement in disease was apparent based on LPPAI which accounts for patient symptoms as well as measurable differences in multiple features of FFA including erythema, perifollicular erythema, and perifollicular scale. More time will be needed to assess for hair growth or disease remission.