As Alopecia UK's Research & Liaison Manager, I was delighted to recently represent the charity at the first Barcelona Hair Meeting at the beginning of October. 

There was a buzz in the air at the conference, with updates on the use of Janus Kinase inhibitor drugs (JAK inhibitors) for treating alopecia areata (AA). Understandably there is enormous expectation around these, as the first new treatment for AA in decades. Eli Lilly, who sponsored a full symposium, are the first pharmaceutical company to receive authorisation for its JAK inhibitor baricitinib (also known as Olumiant) in the USA, Europe, and now the UK.

Attentive and lively with questions, the audience was a mix of dermatologists, pharmacists, trichologists, scientists, pharmaceutical representatives, and staff from Alopecia UK as the sole patient organisation present.

We were reminded that AA occurs due to inflammation around hair follicles – caused by an overactive immune system – and that JAK inhibitors are designed to dampen down this inflammation. So far, two major clinical trials of the efficacy of baricitinib have taken place involving more than 1,200 patients with ‘severe’ AA (hair loss of 50% or more). 34% of patients had scalp hair regrowth within 36 weeks of starting treatment, on a dose of 4mg per day, many with coverage of up to 80% in as little as 26 weeks. And patients continued to show improved hair growth out to the end of the trial periods of 52 weeks, for both scalp hair and eyelashes and eyebrows, according to Dr Sergio Vañó Galván, a dermatologist, trichologist and hair surgeon at the Ramón y Cajal University Hospital in Madrid.

These data were accompanied by impressive photos showing the hair regrowth. However, it was a far from uniform picture – some patients had hair regrowth in the early weeks (the ‘early responders’) while for others it took longer (‘late responders’). For patients with more extensive hair loss (a baseline severity SALT score equal to, or greater than 95), there were fewer who showed hair regrowth. And for patients with alopecia totalis (loss of all scalp hair) or alopecia universalis (all body hair), only around 10% saw hair regrowth, which is less than the 20% that would benefit from treatment with steroids. Around 30% of patients were deemed to be ‘partial responders’ with patchy hair regrowth, while the remaining 30% showed no benefit from baricitinib.

Patients were monitored with blood tests, and assessed for their vaccination status before starting baricitinib treatment. They were also advised to avoid any live vaccines while on the trials – but covid vaccines were acceptable as these do not contain live viruses.

We also heard that serious side effects such as malignancies, viral hepatitis or TB infection (all a potential risk due to the immune-suppressing nature of JAK inhibitors) were rare, and no were more frequent in the treatment group than in the untreated control groups. Mild side effects included acne and headaches, but the overall safety of baricitinib in AA patients appeared to be in line with its use for other conditions. JAK inhibitors were licensed for rheumatoid arthritis in 2017, and for atopic dermatitis or eczema in 2020.

It was clear, however, that treatment with JAK inhibitors is not going to be an immediate option for patients with the first sign of hair loss, and that treatment decisions would need to involve a careful weighing up of the pros and cons.

Firstly, the authorised use of baricitinib is for ‘severe’ alopecia only, on prescription by licensed healthcare professionals. Most importantly, patients with hypersensitivities or who are pregnant (or planning to be) would not be eligible to take baricitinib. And patients aged over 75, or who had a history of recurrent infections, were recommended to not take more than 2mg per day.

This led to the biggest discussion on JAK inhibitors, about when they should be prescribed. The dermatologists presenting believed it was a treatment of last resort, only for patients in ‘trichological emergency’ – with fast shedding or a large area of hair loss. Treatment would be decided depending on the speed and extent of hair loss. 

Dr Jerry Shapiro, a dermatologist who has prescribed baricitinib for patients in his New York clinic, presented a treatment ‘algorithm’ or sequence of decisions, to guide treatment of AA. He first offers patients topical corticosteroid injections, sometimes followed by the drug minoxidil, and then immunotherapy (DCTP), before resorting to a JAK inhibitor.

A second issue is that there is no obvious way yet of telling in advance who will benefit from taking JAK inhibitors.

‘We don’t promise patients when they will see hair regrowth. We have to assess treatment efficacy and when the treatment is not of benefit to the patient… we don’t know what characterises early and late responders,’ noted Dr Bianca Maria Piraccini, Professor in Dermatology at the University of Bologna. She suggested that 36 weeks would be a cut-off point for patients who had not seen restoration of hair growth.

She also highlighted the uncertainty around how long patients should take JAK inhibitors for, and the impact on their alopecia. In future she expected that some patients would have their treatment with JAK inhibitors tapered to a lower dose over time, or to be combined with other treatments such as steroids.

Another issue were patients reported as ‘partial responders’ who experienced some but not full hair regrowth. The differences between these individuals and the early and late responders, may be due to differences in what type of inflammatory processes were active in their skin.

‘We have to learn who are the right patients to put on baricitinib’, said Dr Yuval Ramot, dermatologist at the Hadassah - Hebrew University Medical Center, Jerusalem, Israel. It may be that these patients would be better suited to a different treatment in future aimed at another molecular target.

Even with the promising results so far, there is very little known about the longer-term side effects and potential risks over many years, particularly for younger people who might want to take JAK inhibitors over many years.

So, in summary, JAK inhibitors are not an easy path, and what is coming onto the market now are just the first wave. In future, there may be new variations of JAK inhibitors that target different forms of inflammation more precisely. And there are also new drugs now in clinical trials for AA that target a different set of inflammatory signalling proteins called cytokines. Nonetheless, the news so far on JAK inhibitors has brought a new sense of optimism that a better range of treatment options is on the horizon.

Alopecia UK will continue to represent the patient voice during upcoming consultations, highlighting the huge impact that alopecia can have on a person psychologically, socially and financially, and also emphasising the importance of having access to new treatment options.

To note, this blog focuses primarily on the JAK inhibitor baricitinib because this was the drug discussed during the Eli Lilly symposium in Barcelona. A further JAK inhibitor, ritlecitinib, from pharmaceutical company Pfizer, is also expected to be approved for the treatment of alopecia areata next year.