New FDA drug to regrow hair should be taken with caution




Little did Oscar presenter Chris Rock know that a remark about actor Jada Pinket Smith’s hair loss would bring to fore the emotional trauma that alopecia areata sufferers have to endure.

Now, a ray of hope has emerged with the US Food and Drug Administration approving Olumiant (Baricitinib) oral tablets to treat adult patients with severe alopecia areata. This autoimmune disorder, that appears as patchy baldness, can be life-altering in cases — a total loss of body hair, including eyelashes and eyebrows, even nose hair and hair in the ears.

According to a US FDA press statement on the condition, the body attacks its own hair follicles, causing the hair to fall out in clumps. Olumiant is the inhibitor that blocks the activity of one or more of a specific family of enzymes interfering with the pathway that leads to inflammation. Baricitinib, a drug made by Eli Lilly, regrows hair by blocking the immune system from attacking hair follicles. It treats the entire body rather than a specific location. The efficacy and safety of the drug was tested in two randomised double blind placebo-controlled trials with patients who had at least 50 per cent scalp hair loss.

So what does this breakthrough mean for India? Tofacitinib – which is like Baricitinib – is a novel oral janus-activated kinase inhibitor to control rheumatoid arthritis and is already being used for treating this condition. It is easily available in India at an affordable cost (Rs 25-50 per tablet). Dr Sunil Tolat, consulting dermatologist and honorary professor at B J Government Medical College, Pune, said that unlike male or female patterns of baldness, alopecia areata requires a step ladder treatment tailor-made for each patient. He pointed out that existing forms of treatment may help the hair to grow and apart from anti-inflammatory drugs that suppress the immune system, topical corticosteroids may help too.

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Besides, Dr Tolat said, we must proceed with caution. “There are side effects of the drug and hence we have to conduct a series of investigations, including liver and kidney function tests apart from ruling out latent tuberculosis.” A thorough screening is vital before administering the drug, he emphasised.

“Alopecia areata is a fairly common condition encountered by dermatologists in day to day practice. Three fourth of the patients do not have any known cause for the patchy hair loss. Hence it is called idiopathic. One fourth may have some autoimmune condition, may have skin conditions like atopic dermatitis or may be pre-hypertensive,” added Dr Vidyadhar Sardesai, Professor and Head of Department of Dermatology at Bharati Vidyapeeth deemed university medical college. Many patients do respond to local or systemic treatment modalities, particularly steroids or immunosuppressant drugs like cyclosporine or azathioprine, he said.

The Lilly drug was studied in two trials, sponsored by the company and published last month in the New England Journal of Medicine, involving 1,200 patients with severe alopecia areata. Nearly 40 per cent who took the drug had complete or near-complete hair regrowth after 36 weeks. After a year, nearly half of the patients had their hair back. Dr Brett King, a dermatology professor at Yale University, was the principal investigator for the two Lilly trials and has been reported to have said that he was optimistic that the success rate for the drugs would get better.

As long as there are localized patches in the scalp it is less worrisome for the patient but when the hair loss spreads and involves large portion/entire scalp (Alopecia Totalis) or also involves eyebrows, eyelashes and body hair (Alopecia Universalis), then the quality of life is severely deranged, the expert pointed out.


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