Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to assess the safety and efficacy of Tofacitinib in treating
      patients with extensive and recalcitrant Alopecia Areata (AA), along with to evaluate the
      economic impact of the patients that may be from changing in their quality of life. There are
      patients with severe AA who may have little or no improvement from the treatment by
      diphenylcyclopropenone (DPCP) or topical steroid with minoxidil but instead having positive
      response from the treatment with Janus kinase(JAK) inhibitor such as Tofacitinib or
      Ruxolitinib. For the best of my knowledge, there was no previous study in using Tofacitinib
      to treat severe AA before in Thailand.
    

Detailed description: 
      Alopecia areata (AA) or spot baldness, is a condition in which hair falls off from areas of
      the body. It often happens on the scalp, causing a few bald spots and it may result in
      psychological stress even though people are generally healthy. AA is believed to be an
      autoimmune disease progressing from a breach in the immune privilege of the hair follicles
      that causes hair to fall out in small patches, it may remain unnoticeable until the patches
      eventually connect and then become noticeable. It can develop slowly, and also recur after
      years between occurrences.

      By standard AA treatment guideline, DPCP is the first treatment protocol and may follow with
      anthralin or minoxidil. This oldy but goody treatment gives a good result of 75% in spotty
      hair loss and 25% in total baldness. The new invention of treatment has been introduced in
      the past 2 years by using JAK inhibitor, an oral medicine such as Tofacitinib and
      Ruxolitinib. This treatment gives a good outcome so far in this short period of time,
      54-81.9% of patients had over 50% increase of hair grows over the original protocol. The
      theory is that JAK inhibitors would inhibit interferon-gamma and interleukin-15 signal
      between white blood cell and hair follicle which reducing the rate of destroying hair
      follicles.

      The investigators propose the study to assess the safety and efficacy of Tofacitinib for
      extensive and recalcitrant AA and to evaluate the economic impact effecting the AA patients.
      Tofacitinib is an expensive medicine and needed to be taken up to 6 months to finish the
      course to have a best outcome so it is not a popular choice of AA treatment at present time
      unless it can show a promising result in recalcitrant AA.
    

Intervention name(s): Tofacitinib
Intervention type(s): Drug
Intervention description(s): Tofacitinib is an oral medicine in Janus kinase inhibitor 3 group which has been approved by FDA in treating Rheumatoid Arthritis. It has ability to inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the cause of hair loss.
Other intervention name(s): Xeljanz
Intervention MeSH terms: Tofacitinib
Intervention model: Single Group Assignment
Intervention model description: This is a Cohort study which all recruited volunteers will receive Tofacitinib for total of 24 weeks. The 19 volunteers are mixed male and female Thais who suffer from severe AA over 50% of the entire scalp.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alopecia areata; Alopecia universalis; Alopecia totalis; Tofacitinib; JAK inhibitor