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Alopecia Treatment Update on JAK Inhibitors Ruxolitinib and Tofacitinib

Further to our initial reports on clinical trials involving the study of JAK inhibitor drugs as potential treatments for Alopecia Areata, new information has now become available. Columbia University has just released the findings of this latest study, which have been published in the Science Advances journal.

These latest updates bring with them renewed hope for people with Alopecia Areata (AA), as well as indicating that, with further research, both ruxolitinib and tofacitinib may also prove useful in treating other forms of hair loss.

Research into JAK inhibitors and hair loss

Columbia University JAK Inhibitor Hair Loss Treatment Mice Trial Results

Columbia University’s Latest JAK Inhibitor Hair Loss Treatment Study has Shown Promising Regrowth in Recent Mice Trials Where Half of Each Mouse was Treated Over a 5 Day Period

Janus kinase inhibitors, more commonly known as JAK inhibitors, are a type of drug which suppresses the functionality of JAK enzymes within the body.

As certain JAK enzymes are involved in the hair growth cycle, recent research into whether JAK inhibitor drugs, such as ruxolitinib and tofacitinib, could be plausible hair loss treatments revolves around this aspect.

Initially these drugs were trialled in relation to Alopecia Areata, an autoimmune condition which can cause patchy hair loss through to total baldness. This is because, whilst other forms of hair loss tend to be due to genetics or lifestyle factors, hair fall from AA comes when something triggers the normal hair growth cycle to get stuck in its resting (telogen) phase. What precisely this trigger is is still unknown although stress or sudden shock is thought to be a contributing factor in many cases. Whilst in most cases the hair will generally recover and regrow on its own, when – or indeed, if – this will happen is currently impossible to predict.

Hair Growth Cycle DiagramJAK inhibitor treatment specifically targets the enzymes inside hair follicles which are responsible for maintaining their dormant state in cases of AA. In doing so, they stir the follicles out of the telogen phase and back into active growth.

Columbia’s latest trials studied the impact of JAK inhibitors ruxolitinib and tofacitinib on AA using mice, human hair follicles grown in culture, and human skin grafted onto mice. The latter option was believed to be more effective than using human test subjects as, according to the researchers, transitions from telogen to anagen phases of the hair growth cycle are ‘extremely difficult to assess’ in humans. This is because, unlike mice, humans’ hair growth is not synchronised and 90 per cent of the follicles will be in the growth phase at any time.

In the trials, seven week old, shaved, wild mice were treated daily for five days with either 3 per cent ruxolitinib or tofacitinib regrew new hair within ten days. The control mouse who was given something called a ‘a sonic hedgehog (Shh) agonist’ – a substance which had been ‘previously shown to promote anagen initiation’ showed no hair growth, with its hair continuing to remain in the telogen phase throughout the trial.

Appearance of Skin Pigmentation in JAK Inhibitor Trial MiceThe mice, aged 8.5 weeks, were then treated for a further five days to assess the appearance of skin pigmentation which signals the start of the hair’s anagen growth phase. As you can see from the graph pictured, ruxolitinib excelled here with tofacitinib not far behind, whilst the control languished behind, showing no signs at all.

Based on applying the JAK inhibitors topically (directly to the skin) to interfere with the hair growth mechanism, or ‘pathway’, researchers report that this ‘treatment of mouse and human skin with small-molecule inhibitors of the Janus kinase (JAK)–signal transducer and activator of transcription (STAT) pathway results in rapid onset of anagen and subsequent hair growth.’

In what is believed to be a new discovery, the team further states that their research paper shows ‘that JAK inhibition regulates the activation of key hair follicle populations such as the hair germ and improves the inductivity of cultured human dermal papilla cells by controlling a molecular signature enriched in intact, fully inductive dermal papillae.’

Ruxolitinib (Jakafi)

Ruxolitinib (Brand Name: Jakafi)In October 2014 we brought you details of a promising small-scale trial involving ruxolitinib (brand name: Jakafi) which was taking place at Columbia University.

This clinical study involved investigating the myelofibrosis drug as a potential treatment for Alopecia Areata and produced significant results. Each of the three participants treated with ruxolitinib – all male with a minimum of 30 per cent hair loss of the scalp due to AA – experienced full regrowth within four to five months.

In the recent trials, also carried out by the the same team at Columbia, ruxolitinib was shown to regrow hair in mice in just three weeks. During the initial trial the drug was administered orally, however, this time it was found to be more effective to apply it topically.

Tofacitinib (Xeljanz)

The initial, ‘accidental’ discovery of this JAK inhibitor’s potential for promoting hair regrowth came about when Yale University was investigating tofacitinib (brand name: Xeljanz) as a treatment for plaque psoriasis. The patient they were treating also happened to have Alopecia Universalis and had not grown any hair in seven years, yet at the end of the seven month trial, his hair had fully regrown.

Xeljanz Used to Treat Alopecia Universalis in Yale Hair Loss Treatment StudyTofacitinib is already FDA-approved for the treatment of rheumatoid arthritis (another autoimmune condition), however, there were concerns about the drug’s safety in relation to other potential applications. Earlier this month the drug’s manufacturer, Pfizer, had its supplemental New Drug Application (sNDA) request blocked by the FDA. This application sought to further clear Xeljanz for the treatment of moderate-to-severe plaque psoriasis. A statement posted to the company’s website confirmed that it plans to work with the FDA on this to address all issues, including providing further safety anaylses.

Despite this setback, research into tofacitinib as a potential hair loss treatment, particularly in cases of severe AA – such as Alopecia Totalis and Alopecia Universalis – are continuing. There are currently at least two additional clinical trials underway, both of which are believed to be going well although results will not be available until 2016 at the earliest.

When the Columbia team investigated tofacitinib alongside ruxolitinib, they applied the drug topically whereas in the first trial at Yale it was administered orally in varying doses. As can be seen from the mice pictured above, it promoted significant regrowth.

What next?

Professor Angela Christiano - Alopecia Researcher at Columbia University USA

Professor Angela Christiano

Although the results of the Columbia trial are incredibly encouraging, further and broader studies are still required in order to ensure the long-term efficacy and wider safety implications of using JAK inhibitors to treat Alopecia Areata.

Additional trials can also concentrate on using the team’s discoveries to investigate its potential relevance for the genetic conditions, Male Pattern Baldness and Female Pattern Hair Loss, which are the most common causes of hair loss in the world, beating Alopecia Areata into second place.

These exciting developments ‘open new avenues’ for JAK-STAT inhibition research as well as highlighting the role of this pathway in ‘regulating the activation of hair follicle stem cells’.

Columbia’s Professor Angela Christiano, who has herself experienced AA, explained the significance of using topical JAK inhibitors to promote strong hair growth.

There aren’t many compounds that can push hair follicles into their growth cycle so quickly,’ she told Metro. “Some topical agents induce tufts of hair here and there after a few weeks, but very few compounds have this potent an effect so quickly.” We are assuming that Dr Christiano is referring to minoxidil here, as in cases of mild-to-moderate Alopecia Areata, we have seen encouraging regrowth in many Belgravia clients who follow treatment courses including topically-applied high strength minoxidil.

Talking to the Daily Mail she concluded, “What we’ve found is promising, though we haven’t yet shown it’s a cure for pattern baldness… More work needs to be done to test if JAK inhibitors can induce hair growth in humans using formulations specially made for the scalp.”


Circ The Belgravia Centre Hair Loss Treatment for Alopecia AreataThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.


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28 Comments

25th February, 2016 at 6:54 am

Josh

Amazing findings and encouraging too for everyone out there who has to live with hair loss everyday. One can only hope the trials prove the Chemicals to be safe to use on humans for exteneded periods of time. No point rushing in a drug with serious side effects. Saying that, this might be the most effective treatment to ever hit the shelves. If I had a million I know where Id invest it!

31st March, 2016 at 2:46 pm

Goitsemang Molapong

I am interested to know more since I am suffering from hair loss. I live in Botswana. I am a lady of 53yrs

31st March, 2016 at 3:46 pm

Sarah Belgravia

Hi Goitsemang, these treatments are not actually available yet, they are still in the clinical trial stages. The best thing to do if you are interested is to contact the universities doing the trials directly or speak to your local doctor to let them know that you would like to try these treatments once trials are finished and - assuming all goes well - they become available. This may still be a number of years away though.

15th July, 2016 at 9:25 am

Angshu Bala

This sound is amazing but when this medicine will be available. I need to know as soon as posible.

15th July, 2016 at 1:15 pm

Sarah Belgravia

Hi Angshu, there is no set release date as these drugs still have to complete necessary safety and efficacy tests during clinical trials in order to be approved for use by the public. The latest estimate suggests any widespread release would be no earlier than 2020 but this has yet to be confirmed.

9th August, 2016 at 3:22 pm

hasan...

am i truly going to be able to finally get my hair back???i am in the usa at this time will you be able to help me??how much will it cost???...are using the cream or the pill form??

9th August, 2016 at 4:13 pm

Sarah Belgravia

Hi Hasan, these drugs are still in clinical trials. They are unlikely to be available until at least 2020, although later is more likely - and that is assuming they pass the necessary safety, tolerability and efficacy tests. The final format - whether topical or oral - is likely to depend on the outcome of these trials but topical options are looking particularly promising at present. As soon as there is an more information released on these trials or drugs, we will post updates on the Belgravia blog so do check back for updates.

21st August, 2016 at 11:05 pm

Alb

Will this treatment work only on patients with AA, or will it also work for those with AGA?

22nd August, 2016 at 10:06 am

Sarah Belgravia

Hi Alb, Whilst most JAK inhibitor research is centred on finding a treatment for alopecia areata, totalis and universalis - the types of hair loss caused by autoimmune disorders - some are also being trialled as potential male and female pattern hair loss treatments. However, as this research for all conditions is still in the clinical trial stages it is impossible to confirm either way until the results of the necessary studies are released. As soon as this information becomes available we will add a story about this to our blog so do keep an eye out for updates.

25th September, 2016 at 5:35 am

prashant

when this medicine jak inhibitors get for use

4th October, 2016 at 11:01 am

Sarah Belgravia

Hi Prashant, there is no confirmed date as they are still in the early stages of development. However, we can tell you that, should they pass the necessary safety and efficacy tests, they are unlikely to be available before 2020.

7th October, 2016 at 4:01 pm

Louise

This sounds almost to good to be true. I really hope this is true! It would change my life. Is it possible to have the pills (if they are confirm to be safe) to Europe?

10th October, 2016 at 9:24 am

Sarah Belgravia

Hi Louise, this is something you would need to discuss with your doctor once the medication is available.

13th October, 2016 at 6:13 pm

Fameed

When the medication is released do you have to carry on taking and what do you reckon the price will be in the uk ?

14th October, 2016 at 8:58 am

Sarah Belgravia

Hi Fameed. None of this information is available as the drugs are still in the early stages of testing. It is too soon to tell any of this but as soon as this type of information does become available, or any other updates on these potential treatments, we will post it on our blog so do check back for updates.

25th October, 2016 at 9:07 pm

Louise

But the pills should be for both men and women, right?

26th October, 2016 at 10:29 am

Sarah Belgravia

Hi Louise, yes - the treatment is being trialled on both men and women so hopefully the final treatment should be unisex too.

26th October, 2016 at 7:26 pm

Henryzhagui@yahoo.com

My son has alopecia AA since he was 3 now his 13 and I can't wait for this I

1st November, 2016 at 4:19 am

Ossy

Sarah, does this work on just normal hair loss?

1st November, 2016 at 10:34 am

Sarah Belgravia

Hi Ossy, if you mean genetic hair loss, clinical trials are planned to see if JAK inhibitors could treat male pattern baldness and female pattern hair loss. There is no date set for these trials as yet but we will post updates on the Belgravia hair loss blog as soon as information becomes available.

1st November, 2016 at 5:33 pm

Louise

How sure is this? Is it tested on humans?

1st November, 2016 at 6:05 pm

Sarah Belgravia

Hi Louise, yes it is being tested on humans as well as having been tested on mice in its early stages. Trials are on-going but are looking positive. You can find out the latest updates by scrolling through the Alopecia section of our blog.

21st November, 2016 at 3:12 pm

Louise

Does this come in pills or in creams? Or maybe both?

21st November, 2016 at 3:16 pm

Sarah Belgravia

Hi Louise, it is being trialled in both oral pill form and as a topical cream. However, it is not yet available as it is still in the early stages of clinical trials. Although the results to date appear to be promising, the drugs still need to pass many safety and tolerability tests before they could be prescribed as a hair loss treatment.

27th November, 2016 at 5:43 pm

Louise

Hi again, Is it possible to be a test person?

28th November, 2016 at 11:38 am

Sarah Belgravia

Hi Louise, you would need to contact the universities holding the trials directly as we are not involved in these.

24th December, 2016 at 2:55 am

Meryl Sherriff

I am post-menopausal and because I have an autoimmune disease, I suffer from Frontal Fibrosing Alopecia. I find this very distressing as I have already lost 3 - 4 inches of hair from my hairline. Is there a possibility that eventually this condition can be successfully treated with JAK Inhibitors?

13th January, 2017 at 2:52 pm

Sarah Belgravia

Hi Meryl, at this stage it is impossible to say for certain whether JAK inhibitors could be developed to treat FFA in the future. They have not yet been cleared for use on Alopecia Areata/Totalis/Universalis and the stated goal after gaining clearance for treating these conditions is for the drug to be developed further in order to treat Male Pattern Baldness and Female Pattern Hair Loss.

There are, however, studies that point to various teams trying to develop cures or treatments for FFA. One study recently investigated corticosteriods for this use, whilst another potential hair loss treatment being explored involves lab-grown skin that contains active hair follicles and could help people with various forms of scarring alopecia, including FFA. We will keep our blog updated on developments in this area and believe there is a stronger possibility now than ever before of a future treatment being developed, although please do be aware that this is a long process which can take a number of years to pass all necessary safety and efficacy tests.

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