Oral Hair Loss Treatment Trial Provides Severe Alopecia Regrowth

Despite the recent termination announcement from Aclaris Therapeutics, one of the three pharmaceutical companies that had been leading the way in the development of JAK inhibitor drugs for the treatment of all forms of Alopecia Areata hair loss, this suite of drugs is still being investigated by a number of other parties.

One of these, the School of Medicine at prestigious American Ivy League institution, Yale University, has released its latest findings from a trial exploring treating severe Alopecia Areata, such as Alopecia Universalis, with Xeljanz and oral minoxidil.

During a small-scale trial, it found this combination of oral hair loss treatments provided varying degrees of hair regrowth for almost all of the 12 patients studied.

Two-thirds experienced 75 per cent hair regrowth

One of the first janus kinase inhibition (JAK inhibition) discoveries relating to the treatment of autoimmune-related hair loss disorders - Alopecia Areata, Totalis and Universalis - was made by the team at Yale and related to Xeljanz.

Xeljanz is the brand name for the JAK inhibiting drug tofacitinib, which is made by Pfizer and is currently authorised to treat conditions including rheumatoid arthritis. It has been being trialled by various companies as a potential alopecia areata hair loss solution - in both oral and topical forms - since approximately 2014.

High strength minoxidil is currently used in its topical form to treat androgenetic alopecia - Male Pattern Baldness and Female Pattern Hair Loss - and is both MHRA-licensed and FDA-approved for this purpose. Its oral form is not authorised as a hair loss treatment though it does have the necessary regulatory sanctions as a treatment for high blood pressure.

Although it has only been approved and licensed for genetic hair loss, topical minoxidil is known to have various off-label applications for other hair loss conditions, including as an Alopecia Areata treatment when the condition affects the scalp only. Oral minoxidil is not widely recommended nor used to treat hair loss.

According to research published on 18th September 2019 in the Journal of the American Academy of Dermatology, and covered in the Healio Dermatology publication, 12 adults - 7 women, 5 men - were involved in this latest trial. It looked at results achieved over a period of at least six months.

Each had extensive scalp hair loss that was assessed prior to commencing treatment, and allocated a Severity of Alopecia Tool score which could then be compared to their scores at various intervals during the trial. Baseline hairloss levels were recorded as a median score of 99.5% across all trial participants, meaning they were all almost entirely bald.

The following results were noted by researchers, though the precise timeline for each is not yet available:

- 8 out of the 12 patients achieved 75 per cent hair regrowth to their scalp, represented by a SALT score of 75;

- 4 out of the 12 patients received a SALT score of between 11 and 74, meaning they saw scalp hair regrowth improvements of between 11 and 74 per cent.

Initial dosing involved all male patients being administered a Xeljanz 5mg tablet once each day and 2.5mg of oral minoxidil twice per day; all female patients were given a 5mg Xeljanz tablet once a day and 2.5mg of oral minoxidil once per day in order to minimise the potential for hypertrichosis - the development of excessive or unusual hair growth, such as facial hair.

However, of the eight patients observed to reach a SALT 75 score, seven used tofacitinib (Xeljanz) 5 mg twice per day and the eighth candidate in this result group had their Xeljanz dose increased to 10 mg twice per day after not responding to 5 mg twice daily over the 4 to 6 month period.

"Emerging as an important therapy for severe alopecia"

Although the trial's overall median final SALT score was 6.5 per cent, the team was keen to stress some significant individual responses and the importance of continuing to explore JAK inhibitors in relation to treating the types of alopecia areata which currently have few safe and effective therapeutic options.

According to Carlos G. Wambier, MD, PhD, of the department of dermatology at Yale and part of the team led by Dr. Brett King, "...one patient who had not achieved any hair regrowth 1 year prior with tofacitinib 11 mg extended release once daily for 3 months, experienced substantial hair regrowth over the first 3 months of combination therapy with the equivalent dose of tofacitinib, 5 mg twice daily...

Janus kinase inhibitors are emerging as an important therapy for severe alopecia areata and the possibility of increasing efficacy without increasing Janus kinase inhibitor dosage (and immunomodulation and cost of treatment) would be welcome.”

The potentially prohibitive cost of Xeljanz, including whether it would be carried by the NHS and covered by insurance companies in America has been an on-going concern since JAK inhibitors were first mentioned as potential Alopecia Areata treatments.

Another troubling factor, which may explain why the Yale team has looked to combining a JAK inhibitor with another hair growth drug, has been the current side effect profile of Xeljanz. Topical versions of the medication have been tested separately in order to help reduce the likelihood of these serious adverse events - ranging from headaches and upper respiratory tract infections, to shingles and an increased risk of tuberculosis - occurring.

As research to produce the first safe, tolerable and effective JAK inhibitor-based hair loss treatments continues, anyone concerned about sudden hair fall from their scalp or other areas of their body are advised to seek professional assistance as soon as possible.

Though a hair loss specialist will generally be able to help adults with the scalp-only form, those losing hair from their body or where they are under 16 years of age shoudl