Although the trial was initially thought to be exploring abatacept in relation to Alopecia Areata of the scalp, through to Alopecia Totalis and Alopecia Universalis - the more severe forms which also cause hair loss of the head and body - this confirms that it concentrated solely on the scalp-only form.
Columbia University Department of Dermatology's Clinical Research Unit, New York, in collaboration with the biopharmaceutical company Bristol-Myers Squibb updated the trial registration with these results on 17th April 2019.
The open label trial involved 15 participants with Alopecia Areata - 9 females and 6 males, all between 21 and 62 years old, with a mean age of 39. Of the 15 who started the trial, 14 completed the study with one withdrawing for reasons not stated in the documentation.
Each volunteer self-administered injections of 125mg abatacept each week for 6 months in order to determine the short-term efficacy and safety of the potential treatment. The responders were then followed for a further six months once they had stopped using abatacept.
The primary aim of the Columbia trial was to gauge how well the participants tolerated the abatacept as well as the hair regrowth they experienced that could be attributed to the drug.
Studying hair regrowth in relation to the patchy hair loss of the scalp caused by Alopecia Areata can be tricky given this particular form of autoimmune alopecia is prone to spontaneous remission. In many cases, the hair grows back naturally within 12 months, though if or when it may do so cannot be predicted. This makes it difficult for researchers to know what is natural hair growth and which results are directly attributable to treatment.
In order to address this issue, researchers established the following protocols: "The study's primary efficacy endpoint will be the proportion of responders after 6 months of treatment, with response defined as 50% of greatr hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously."
Of the 15 patients analyzed - one of whom later dropped out - the mean SALT scores were recorded as follows, with a standard deviation of 3.8 for all readings:
No serious adverse effects were noted in any of the test subjects, however, six reported upper respiratory infection symptoms, one experienced a recurrent yeast infection and three had side effects including body aches, tightness at the injection site and tingling of the hands or arms.
The trial documentation does not state whereabouts the injections were administered to, though usually where subcutaneous treatments for hair loss are involved, they are injected directly into the scalp. In this case, as it mentions hands and arms in relation to 'site injection' adverse effects, it may be that the injections were administered to the arm.
As before, in many cases hair growth will resume naturally, usually within 12 months of the first bald spot appearing, but this is not always the case.
As the British Association of Dermatologists advises, "Depending on the extent of hair loss there is a good chance that, for 4 out of 5 affected people, complete regrowth will occur within 1 year without treatment. There may, however, be further episodes of hair loss in the future. If there is very extensive hair loss from the start, the chances of it regrowing are not as good. Those with more than half the hair lost at the beginning or with complete hair loss at any stage have only about a 1 in 10 chance of full recovery. The chances of regrowth are not so good in young children and those with the condition affecting the hairline at the front, side or back." Continues below...
For those wishing to explore hair loss solutions to help their regrowth along, there are already a number of Alopecia Areata treatment options available, especially for adults, where the scalp-only phenotype is concerned.
These range from topical applications of high strength minoxidil - a medication which promotes hair growth and is currently both MHRA-licensed and FDA-approved for the treatment of genetic hair loss - to more invasive approaches, such as steroid injections.
Adults wishing to investigate the best options for their condition are advised to consult a hair loss specialist or dermatologist, whilst those with children aged 15 or under should speak to their GP as a first port of call.
The Belgravia Centre is a world-renowned group of a hair loss clinic in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation from anywhere in the world for home-use treatment.
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