JAK Inhibitor Trial Produces Mixed Results for Alopecia Areata

Janus Kinase inhibition is currently one of the most exciting areas of development in the hair loss industry. Clinical trials have been underway for a number of years into various forms of these drugs which are more commonly referred to as JAK inhibitors.

Trials using various drugs from this family have managed to help people with the severe - and currently untreatable - conditions Alopecia Totalis and Alopecia Universalis to regrow their hair. One of the first of these was an oral medication called tofacitinib citrate which is made by Pfizer and currently approved by the FDA for the treatment of rheumatoid arthritis. This goes under the brand name Xeljanz.

Initial concerns over the potential side effects of Xeljanz were flagged as problematic, as was the potentially prohibitively high price of the drug.

Now, however, trial findings are also showing that hair growth results from those taking these drugs for a range of autoimmune hair loss conditions, from the mild Alopecia Areata to the more serious forms, Totalis and Universalis, are showing a mixed range of efficacy.

Oral tofacitinib hair growth results

The JAMA Dermatology journal published a widely reported research letter on the subject, authored by members of the Department of Dermatology at the Cleveland Clinic Foundation in Ohio, USA.

For their study, the researchers examined medical records of Cleveland Clinic patients with a confirmed autoimmune alopecia diagnosis who were treated with a 'standardized, systematic treatment regimen' of Xeljanz. The review took place between May 1 and June 1 2016.

Of the 13 patients studied, two had alopecia totalis and 7 had alopecia universalis. The remaining 5 had alopecia areata and all patients ceased any form of treatment or therapy prior to commencing JAK inhibitor treatment. The mean average amount of scalp hairloss across all these patients before treatment started was 93 per cent.

Treatment comprised 5mg tofacitinib citrate (Xeljanz) taken orally twice per day. This daily dose was increased by 5mg each month until hair growth became apparent, then the tofacitinib dosage at which regrowth first presented was maintained.

It took between 1 to 9 months for the patients involved to display signs of hair growth, and regrowth rates varied from 2 per cent to 90 per cent. Of the 13 patients, 7 achieved at least 50 per cent regrowth and three terminated treatment - two due to loss of medical insurance and one who pulled out after developing morbilliform eruption and peripheral edema.

In terms of side effects noted during the treatment period, two of the surveyed patients experienced issues with lipid and liver abnormalities though these were dealt with by reducing their doses.

It was noted that there were 'limitations' to the study, including the fact that there was no control group with which to compare results. The fact that only 13 patients featured, making it a particularly small scale study, should also be considered a limiting factor. Continues below...

One of the patients studied who attained 90% regrowth after 3 months of treatment for Alopecia Totalis with Xeljanz

Effects show 'lack of durability'

The paper states: “Although small, our cohort achieved greater median improvement in SALT scores than reported in previous studies (50.5% vs. 21%).”

“This outcome may be related to our higher doses, longer duration of therapy, and patients’ shorter duration of current disease episode.

"Oral tofacitinib is a successful treatment for [alopecia areata] but its efficacy varies widely..." Researchers agreed that, in order to properly assess the drug's potential as a treatment for alopecia areata, "trials should continue in the clinical setting for a minimum of 4 months and potentially up to 1 year.”

A key finding that was highlighted in this investigation was the fact that treatment with Xeljanz would need to be on-going in order to be effective. As the research letter explains: "In addition, our results demonstrate lack of durability of effect after the discontinuation of therapy, a finding similar to that of other studies."

There are already alopecia areata treatment courses available that have been shown to be effective in many cases for those with the mild to moderate form (that which causes patchy hair loss to the scalp only). Therefore, introducing a more expensive option of oral medication that may have no discernible extra benefits from following a bespoke treatment course featuring topical applications of high strength minoxidil is potentially only of interest to those experiencing the more serious and untreatable iterations of alopecia.

It also faces stiff competition as a future treatment for alopecia totalis and alopecia universalis from the newly patented JAK inhibitors being developed by Columbia University's School of Medicine in conjunction with Aclaris Therapeutics. These drugs are currently known and registered as baricitinib and decernotinib.

Although they too are still in the process of completing the various necessary clinical trials regarding safety, efficacy and tolerability, these drugs are expected to be read for release in the next few years, bringing hope to many people who have never before had a reliable treatment option to regrow the hair they have lost from their scalp, face and body.