This week, the US Food and Drug Administration (FDA) approved the use of baricitinib (brand name Olumiant) to treat patients experiencing severe alopecia areata .
Alopecia areata is one of the most difficult types of hair loss to treat. It has a high rate of spontaneous remission — those with mild cases often see their hair grow back without treatment — but episodes can recur sporadically, causing emotional distress .
Researchers have called alopecia areata a “major unsolved clinical problem.” And until now, few successful treatments have been made available for patients with severe alopecia areata [2, 3]. But two new studies suggest that the JAK inhibitor Olumiant can promote hair regrowth even in those with sustained, severe alopecia areata. The FDA’s approval of Olumiant on Monday is a breakthrough for US patients with severe alopecia areata.
What causes alopecia areata?
While not all clinicians agree, alopecia areata is usually recognised as an autoimmune disorder . The body’s immune system attacks the hair follicles, causing them to stop producing hair.
Follicles usually have high levels of immune-privilege. That means mechanisms are present within the hair follicle that suppress immune attacks. But when immune privilege collapses, these mechanisms can fail, leading to alopecia areata. Studies suggest that restoring immune privilege can effectively treat alopecia areata .
What is Olumiant and how does it work?
Baricitinib, or Olumiant, is a Janus kinase (JAK) inhibitor. JAKs are enzymes that transmit immune response signals throughout the body. Olumiant works by blocking these enzymes and suppressing the immune response signals, so the body’s immune system doesn’t react and attack the follicles.
Olumiant is a systemic treatment. That means it treats the entire body, rather than just the specific area affected by hair loss. Clinicians usually prescribe one tablet a day. It’s available in two doses — 2mg and 4mg. In the two recent studies, the 4mg dose was generally shown to be more effective than 2mg [5, 6].
Olumiant has previously been approved to treat rheumatoid arthritis. It can also treat certain patients who have been hospitalised with Covid-19 in the US .
Why has this treatment just been approved in the US?
The FDA has just approved Olumiant to treat alopecia areata thanks to promising results from two significant trials. These studies compared the effectiveness of baricitinib for achieving substantial hair regrowth with a placebo. Each study compared results from more than 500 participants who had lost at least 50% of their scalp hair to alopecia areata.
Results from the first trial showed that 30% of patients receiving Olumiant treatment achieved adequate scalp coverage, compared to just 5% of patients receiving a placebo . In the second study, 26% of patients taking Olumiant also saw adequate hair regrowth, compared with 3% taking a placebo . So while Olumiant may not work for everyone, its efficacy has led the FDA to make it available for severe alopecia areata sufferers.
What are the side effects of Olumiant?
Some of the most common side effects of Olumiant include:
- High cholesterol
- Urinary tract infections
- Respiratory tract infections .
There are also potentially serious side effects such as shingles and venous thromboembolism. If you notice leg pain or swelling while taking Olumiant, speak to your doctor immediately.
Is Oluminant available in the UK?
Oluminant is currently approved for use in the UK and EU to treat rheumatoid arthritis and atopic dermatitis. It hasn’t yet been approved by the MHRA to treat alopecia areata, but with the FDA now ruling it to be suitable for treating alopecia areata, there’s hope for alopecia areata sufferers in the UK, too.
In the meantime, other non-systemic treatments for alopecia areata are available in the UK. These include corticosteroids and topical treatments like Minoxidil. Researchers are also investigating other JAK inhibitors (such as Tofacitinib and Ruxolitinib) as potential future treatments.
Do you have alopecia areata?
If you’ve noticed patchy bald spots on your scalp or elsewhere on your body, you may be experiencing alopecia areata. But there are dozens of hair loss causes, so it’s not always easy to self-diagnose alopecia areata. To find out what’s causing your hair loss — and how you can treat it in the UK — book a free consultation at our Harley Street hair loss clinic.
- FDA Approves First Systemic Treatment for Alopecia Areata
- Guidelines for the management of alopecia areata
- What causes alopecia areata?
- The Hair Follicle and Immune Privilege
- A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)
- A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (BRAVE-AA2)
- FDA Approves Lilly and Incyte’s OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19
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