The full results for Yale University’s clinical trial investigating whether topical tofacitinib could prove a safe and effective method of treating mild-to-severe Alopecia Areata were published on 30th January 2019.
Alopecia Areata is an autoimmune disorder which causes the body to attack its own hair follicles, leading to anything from rounded patchy bald spots on the scalp to full baldness from head-to-toe. Tofacitinib is a drug from a suite known as Janus Kinase inhibitors – or JAK inhibitors – which are being trialled to address these currently largely untreatable conditions, as they appear to prevent the immune system response against the follicles.
The small-scale trial was first registered with the clinicaltrials.gov website in June 2016, with a summary of its findings being made available in October 2018.
One of the key takeaways from this research is the apparently minimal side effect profile the JAK inhibitor showed during this study. This is something which had been a potential cause for concern given the adverse effects previously associated with the oral form of this medication, currently only authorised for prescription use as a treatment for rheumatoid arthritis.
No serious adverse effects reported
The Yale University research was led by the Ivy League college’s Associate Professor of Dermatology, Dr. Brett King, who is a well-known and respected specialist in the field of autoimmune alopecia.
Of the US-based Phase 2 trial’s 10 participants, 8 were Caucasian and 2 were Asian; 4 were women and 6 were men, all of whom were 18 years of age or older, with a mean age of 36.9 years.
The group’s mean SALT score (the measurement using the Severity of Alopecia Tool) was 77.7 – meaning an average amount of hair loss per volunteer of just over three quarters of the scalp.
The recruits each had extensive Alopecia Areata or one of its more extreme phenotypes which each cause total baldness of the scalp, as well as affecting other hair-bearing areas of the head and/or body – Alopecia Totalis and Alopecia Universalis.
All ten test subjects were treated for up to six months with topical tofacitinib ointment, and assessed every four weeks.
The efficacy of the medication, for which the dose information was not provided, was evaluated on the changes in hair growth at the end of treatment compared to the individuals’ baseline measurements from just before the study commenced.
Whilst little data is provided, even in this final outcome report, it appears that a mean average of 10 per cent decrease in participants’ SALT score was recorded (where the lower the SALT score corresponded to the more hair growth that occurred) over the six months period. It was also stated that 30 per cent – or three – of the volunteers who responded well to this treatment were then analysed.
Of all the ten patients who took part, it was notable that none reported any serious adverse events over a 12 month period. This includes the six months during which they were using topical tofacitinib and the following six months afterwards when they were not.
The only side effects users complained of were considered mild, with 2 out of 10 experiencing headaches, 4 having an upper respiratory infection, 1 having a sinus infection, 1 developing folliculitis and 4 noting skin irritation of their scalp.
Importance of developing severe Alopecia Areata treatments
Despite research finding that Alopecia Areata is less distressing than Male and Female Pattern Hair Loss is to those affected, it is well established that the sudden hair fall and visible nature of the condition can have traumatic effects. A number of mental health disorders, including depression and anxiety, have been shown to be triggered following the onset of these autoimmune diseases.
Although Alopecia Areata treatment can be beneficial for the patchy, scalp only form – which in most cases will clear up naturally within 12 months – the options are far more limited and often less successful when it comes to the more severe phenotypes.
Because of this ‘unmet need’, the American medical regulatory board, the FDA, has granted fast track status to a number of potential therapies for all types of Alopecia Areata, which are all in the latter stages of development.
In a news article on the Yale Medicine website, Dr. King explains the reasons behind his pursuit of JAK inhibitor treatment for Alopecia Areata in all its forms – for both adults and children.
“Some may argue it’s just hair,” he says. “But hair frames the person you see in the mirror. It’s a sign of youth and vitality—of life. Patients have told me that without hair, eyebrows and eyelashes, they feel like ghosts.”
“For us, this is about giving people back normalcy and giving them the opportunity to achieve everything they have the potential to become.”
JAK inhibitors are not currently available for prescription as a hair loss treatment outside of clinical trials, in the UK, USA nor any other country that we are aware of. However, in March 2017 Dr. King estimated JAK inhibitors may be ready for release – assuming the relevant medical authorisations from organisations such as the MHRA and FDA are forthcoming and granted in a timely manner – by 2021.
With a number of trials in the Phase 3 stage already, we would assume that – again, if everything goes to plan – these should be available from 2021-2022, and will publish any new information regarding this timeline here on the Belgravia hair loss blog.
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