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Olumiant: First Systemic Treatment for Alopecia Areata Approved in the US
Dr Luciano Sciacca (GMC)
Medically reviewed by
Dr Luciano Sciacca (GMC)
Updated on March 14, 2024

This week, the US Food and Drug Administration (FDA) approved the use of baricitinib (brand name Olumiant) to treat patients experiencing severe alopecia areata [1].

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 [2].

Researchers have called alopecia areata a “major unsolved clinical problem.” until now, few successful treatments have been made available for patients with severe alopecia areata [2, 3]. However, 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 is a breakthrough for US patients with severe alopecia areata.

Table of Contents

What causes alopecia areata?

While not all clinicians agree, alopecia areata is usually recognised as an autoimmune disorder [3]. The body’s immune system attacks the hair follicles, causing them to stop producing hair.

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 [4].

examples of alopecia areata on the scalp
Examples of alopecia areata

What is Olumiant?

Olumiant is a Janus kinase (JAK) inhibitor. It is currently available as a prescription medication used to treat the following conditions:

  • Adults with moderate to severe active rheumatoid arthritis-This drug can only be given if the adult patients with rheumatoid arthritis had an inadequate response to other rheumatoid arthritis treatments
  • Adults with severe alopecia areata
  • Adults with moderate to severe atopic dermatitis (eczema)-This drug may be prescribed when other topical treatments have not worked.

Although Olumiant has previously been approved to treat severe rheumatoid arthritis, there’s some evidence to suggest JAK inhibitors can treat scarring alopecia as well as alopecia areata. It can also treat certain patients who have been hospitalised with Covid-19 in the US [7]. Covid has also been linked with other types of hair loss, such as telogen effluvium.

How does Olumiant 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 hair follicles.

Olumiant is a systemic treatment. That means it treats the entire body, rather than just the specific area affected by hair loss.

Why has this treatment 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 [5]. In the second study, 26% of patients taking Olumiant also saw adequate hair regrowth, compared with 3% taking a placebo [6]. So while Olumiant may not work for everyone, its efficacy has led the FDA to make it available for severe alopecia areata sufferers.

Other new JAK inhibitor treatments for alopecia areata are also emerging. Find out about upcoming Olumiant rival ritlecitinib, a Pfizer alopecia drug.

Who can take Olumiant for alopecia areata?

Olumiant is suitable for individuals who are seeking treatment for their severe alopecia areata. Due to its nature as an immunosuppressant, Olumiant is not suitable for the following individuals:

  • Pregnant women
  • Adults over the age of 65
  • Adult patients with a history of cardiovascular disease (heart attack or stroke)
  • Individuals with cardiovascular risk factors (ex. current or long-time smokers)
  • Individuals who have an increased risk of cancer
  • Individuals who are allergic to baricitinib or any other ingredients in Olumiant
  • Individuals with a weakened immune system or anyone prone to developing infections

What are the side effects of Olumiant?

Some of the most common side effects of Olumiant include:

  • Headache
  • Acne
  • High cholesterol
  • Urinary tract infections
  • Folliculitis
  • Fatigue
  • Nausea
  • Respiratory tract infections [1]
  • Cold sores
  • Rashes

Risk of blood clots

There are also potentially serious side effects such as shingles and venous thromboembolism (blood clots). If you notice leg pain or swelling while taking Olumiant, speak to your doctor immediately.

Risk of serious infections

Due to its nature as an immunosuppressant, individuals taking Olumiant may develop a weakened immune system which may lead to an increased risk of serious infections. If the patient becomes sick and develops an infection then it is recommended that the patient stop their Olumiant treatment until their infection has cleared. [8]

Risk of cancer

Taking Olumiant may increase your risk of developing certain cancers such as non-melanoma skin cancer. As a result, patients are advised to undergo regular skin examinations while taking Olumiant. [9]

As always, tell your doctor immediately if you have developed any serious side effects that might be life-threatening or require emergency medical attention from healthcare professionals.

What is the dosage for Olumiant?

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 can be taken with or without food. If a dose is missed, take it as soon as you remember. If you forget to take Olumiant, take it the next day as your doctor or pharmacist advises. Do not take a double dose.

Is Olumiant available in the UK?

Olumiant is currently approved for use in the UK and EU to treat rheumatoid arthritis, COVID, severe alopecia areata, and other health conditions by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The medication, however, is not available on the NHS to alopecia patients and is therefore only available with a private prescription [10].

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. Hair transplants for alopecia areata patients aren’t usually recommended.

alopecia areata before and after using Rogaine
alopecia areata before and after using Rogaine (Minoxidil)

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. Alopecia barbae, a type of alopecia areata, affects only the beard.

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 stop your alopecia areata from spreading — book a free consultation at our Harley Street hair loss clinic.

Olumiant: First Systemic Treatment for Alopecia Areata Approved in the US, Wimpole Clinic

Dr Luciano Sciacca (GMC)
Medically reviewed by Dr Luciano Sciacca (GMC)Updated on March 14, 2024
The Wimpole Clinic offers FUE Hair, Beard & Eyebrow Transplants & Trichology.
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