Phase Four Alopecia Areata Tofacitinib Clinical Trial Begins

A new Phase 4 clinical trial into the JAK inhibitor tofacitinib as a potential treatment for Alopecia Areata, started on 12th January 2019 in Thailand.

Announced via its trial registration entry at clinicaltrials.gov, the country's Institute of Dermatology is investigating the oral drug, also known by its brand name, Xeljanz, on all forms of hair loss caused by the autoimmune disorder.

Results are currently expected in September 2020.

First tofacitinib study in Thailand

Tofacitinib has already produced compelling hair regrowth results in trial settings for a number of patients with mild-to-moderate Alopecia Areata (patchy hair loss of the scalp only), and the more severe phenotypes Alopecia Totalis (total baldness of the scalp often accompanied by facial hair loss) and Alopecia Universalis (complete loss of hair from head to toe) in the USA.

The pharmaceutical company Aclaris Therapeutics has also been granted patents for using tofacitinib in the treatment of Alopecia Areata in America. However, this is believed to be the first investigation of its kind to take place in Thailand.

The Institute's study author states: "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."

It is a small scale trial with only 19 participants - both male and female, all with a minimum of 50 per cent hair loss of the scalp - who are taking tofacitinib for a total of 24 weeks.

Quite why this clinical trial is billed as a 'Phase 4' study is unclear given Phase 4 is generally the stage that takes place after a drug has received all necessary authorisations by the relevant medical regulatory boards - such as the MHRA in the UK and the FDA in the USA - and released for prescription. It is also known as the 'marketing surveillance' phase where user feedback is garnered, and is on-going.

Concern over cost of JAK inhibitor treatment

One aspect of the Thai study that echoes some Western sentiments, is the cost of tofacitinib. There have been various concerns expressed as to whether the price of JAK inhibitor treatment for Alopecia Areata could be potentially prohibitive to a lot of patients.

This new study appears to be unique in that it is assessing not only the safety and efficacy of the drug, but also the 'economic impact' on patients. As the author says, "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 Alopecia Areata treatment at present time unless it can show a promising result in recalcitrant AA."

This is just one of many investigations into tofacitinib and a range of other JAK inhibitors, hoping to provide the first safe and effective treatment for those with the most extreme - and often distressing - forms of Alopecia Areata. Updates on all of these will be published on the Belgravia Centre hair loss blog as soon as more information becomes available.