Alopecia Areata JAK Inhibitor Drugs Expected Release Date

One of the most significant recent breakthroughs in the world of hair loss has been the promising clinical trial results of drugs known as Janus Kinase inhibitors.

Certain JAK inhibitors have been seen to regrow hair lost to the most severe forms of Alopecia Areata for both men and women in small scale trials. This includes Alopecia Universalis, the most extreme version of this autoimmune disorder, which causes total baldness from head to toe, and Alopecia Totalis which causes hair loss from the entire scalp and often the face as well.

Whilst there are already effective alopecia areata treatment courses available for the mild form which causes patchy hair loss to the scalp only, these trials have garnered widespread attention as there are currently no truly effective treatments for Alopecia Totalis or Alopecia Universalis. Therefore, these drugs - if approved - could provide a hitherto nonexistent option for those affected.



Trials have been on-going and, though frequent reports on their progress have been forthcoming, one thing that has remained elusive is an estimated release date - until now.

A few years away

Whilst 2020 has been assumed by many in the field, this was not officially confirmed. This has been frustrating for those anxious to find out more, but now Dr Brett King of America's Yale University, which has been at the forefront of this research, has announced further information.

Medscape Medical News reports that Dr. King told them he 'expects a JAK inhibitor to be approved for the treatment of moderate to severe eczema in 2 years and for the treatment of moderate to severe alopecia areata in 2 to 3 years'. This means that the estimates of 2020 are not too far off, as the predicted release date is 2020-2021.

Whilst this is definitely exciting news, it is worth remembering that, until a medication has been properly and successfully trialled for safety, efficacy and tolerability, as well as getting MHRA and FDA approval, there is no guarantee that it will ever make it to market.

One of the major concerns to date has been potential side effects though topical versions of these medications, that are applied solely where they are needed, are being tested in addition to oral options, in order to see if this has a beneficial effect.

Two JAK inhibitor drugs leading the way

The two potential alopecia areata treatment JAK inhibitor drugs that are currently showing the most promise, according to published clinical trial results, are Tofacitinib Citrate and Ruxolitinib. It is therefore likely that one, or both, of these are the specific drugs Dr. King is referring to.

Tofacitinib, which is also known by its brand name: Xeljanz, is manufactured by Pfizer. It is currently only approved by the FDA for the treatment of moderate to severe cases of rheumatoid arthritis which, like Alopecia Areata in its various forms, is an autoimmune disorder. The drug has caused controversy over its side effect profile which includes 'serious infections', including tuberculosis, and 'certain cancers'. It is therefore not yet available in certain countries, including the UK as the MHRA has not granted a license.

Tofacitinib has mostly been investigated in relation to alopecia areata by teams at Yale University in America. In various recent trials it has been shown to regrow hair in various cases of autoimmune hair loss, as well as restoring eyebrows and reversing nail dystrophy - a common side effect of alopecia totalis and universalis.

Ruxolitinib, which also goes under the brand name of Jakafi, is a product of the Incyte Corporation. It has been approved by the FDA for the treatment of intermediate or high-risk myelofibrosis (a serious bone marrow condition) as well as inflammatory diseases and some forms of cancer.

Ruxolitinib has mostly been investigated as a potential severe alopecia areata drug, in oral and topical forms, by researchers from Columbia University in the US, including the pre-eminent Dr Angela Christiano. To date, these trials have found that the topical cream version of ruxolitinib is more effective than the oral medication when treating autoimmune hair loss.

As he has been heavily involved with tofacitinib trials - and gave his most recent presentation on the drug at the American Academy of Dermatology Annual Meeting in early March 2017 - we would expect he hopes this to come through first. Another reason that tofacitinib may be preferable to ruxolitinib, given their success rates in trials seem similar, is the cost. Dr. King advises that ruxolitinib costs "more than $100,000 per year and tofacitinib is more in the range of biologics." Biologic drugs, such as Humira, which has also been tested as a potential hair loss treatment, are significantly cheaper, clocking in around the $1,800 - $2,500 per year mark.

Whilst the research results for both drugs, particularly in relation to severe Alopecia Areata, have been encouraging to date, there is still the need for larger scale clinical trials. As Dr. King says, "We'll see what we can do in vitiligo in the next year to make the case for large clinical trials." We look forward to reading the next installment from both camps as research progresses, and will post updates here on the Belgravia hair loss blog as news becomes available.