FDA approves Olumiant for hair loss treatment Severe Alopecia

FDA approves Olumiant for hair loss treatment Severe Alopecia

FDA approves Olumiant for hair loss
FDA approves Olumiant for hair loss treatment Severe Alopecia

The Food and Drug Administration (FDA) originally approved Olumiant (baricitinib) in 2018 to treat rheumatoid arthritis.

The approval of Oluminant reportedly marks the first time the FDA approved a “systemic treatment” for this form of alopecia.

Olumiant is available in tablet form and is a daily medication.

There are several forms of alopecia, including alopecia areata, an autoimmune skin disease that causes bald patches. According to the American Academy of Dermatology Association (AAD), the immune system attacks the hair follicles, which leads to hair falling out.


The National Organization for Rare Disorders reports that alopecia areata affects around 2.5 million Americans. While many people experience mild cases of alopecia and only have one or two bald patches, others develop more severe cases and have a significant amount of hair loss.


People can develop alopecia at any time in their lives, but the AAD indicates that most people who have it first see symptoms by the time they are 30 years old.



Alopecia treatment options

While there is no cure for alopecia, there are some treatments available that can stimulate hair growth.


Corticosteroids can either be injected into the affected area or applied as a topical treatment. Doctors often prescribe topical corticosteroids to younger people with alopecia.


Another treatment is immunotherapy. According to the National Alopecia Areata Foundation, this treatment “causes an allergic rash (allergic contact dermatitis) that looks like poison oak or ivy, which alters the immune response.”


Finally, there is another type of drugs called Janus kinase (JAK) inhibitors. JAK inhibitors treat a variety of inflammatory diseases.


The FDA has now approvedTrusted Source another such drug, called Olumiant, traditionally used in the treatment of rheumatoid arthritis, for the treatment of alopecia areata.



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How Olumiant works

CytokinesTrusted Source, which are proteins involved in cell signaling, play a role in autoimmune diseases. When the body produces an excessive amount of cytokines, this can dysregulate the immune system.


Oluminant works by interrupting cytokine cell signaling as well as the signaling pathways of enzymes.


This affects the body by lowering its immune system. As a result, Olumiant creates an opportunity for the body to start growing hair again.



Olumiant trials

The FDA based its approval on two recent phase 3 trials, THRIVE-AA1 and THRIVE-AA2 that Olumiant manufacturer Eli Lilly conducted.


Participants had to have a severe case of alopecia to participate in the trials, with at least a 50% hair scalp loss occurring for at least 6 months.


Both trials consisted of three groups each. The first group received a 2-milligram (mg) daily dose of Oluminant, the second group received 4 mg of Oluminant daily, and the third group received a daily placebo.


The goal was for the participants to see “adequate scalp hair coverage,” which researchers defined as having at least 80% scalp hair coverage by week 36 of the trial.


Of the participants in the first trial, 22% who took 2 mg of Olumiant, and 35% of participants who took 4 mg saw adequate coverage. Of the placebo group, 5% had adequate coverage.


The results were slightly lower for the second trial.


Of the participants who took 2 mg of Olumiant, 17% saw adequate scalp hair coverage. Of the participants who took 4 mg, 32% saw adequate coverage, and 3% of the participants who took a placebo saw adequate coverage.


Olumiant safety information

Olumiant reports a number of common side effects, including:


upper respiratory tract infections


high cholesterol

urinary tract infections



The drug also comes with a boxed warning that notes the medication can cause serious issues, such as tuberculosis. Additionally, Oluminant can cause people to have a higher risk for cancer, heart attacks, and strokes.


During the Olumiant trials, only 2.2% of participants quit due to adverse reactions.


Important pros and cons

Dr. Ken L. Williams Jr., surgeon and founder of Orange County Hair Restoration in Irvine, CA, spoke with Medical News Today about the FDA’s approval of Olumiant for alopecia areata.


Dr. Williams said that for patients with more advanced forms of alopecia who have emotional difficulty with the disease, “consideration of this medication for certain patients may be warranted.”


Dr. Williams also expressed some concerns about Olumiant and how it can possibly affect one’s health.


“This medication decreases a human’s ability to fight infections,” Dr. Williams said. “Other important serious side effects of immunosuppression are tuberculosis and susceptibility to environmental pathogens such as bacteria, fungi, and viruses.”


The doctor also noted that such infections can potentially be fatal.


“In my opinion, for the more common clinical presentation of alopecia areata such as localized patches of hair loss, the potentially serious effects of this medication limits its use,” commented Dr. Williams.


Biology / BiochemistryClinical Trials / Drug TrialsImmune System / Vaccines

Alopecia areata: Causes, diagnosis and treatments

Medically reviewed by Shilpa Amin, M.D., CAQ, FAAFP — Written by James McIntosh — Updated on April 7, 2022

Home remedies


Alopecia areata is a common autoimmune disorder that often results in unpredictable hair loss.


It affects roughly 6.8 million people in the United States and 147 million people worldwide.


In most cases, hair falls out in small patches around the size of a quarter. There may be only a few patches, but alopecia areata can affect wider areas of the scalp.


If there is a complete loss of hair on the scalp, doctors diagnose alopecia totalis. If there is hair loss throughout the entire body, the condition is called alopecia universalis.


Alopecia can affect anyone, regardless of age, gender, or race, though most cases develop before the age of 30.


In this article, we look at the causes and symptoms of alopecia areata, its diagnosis, and potential treatments.




Alopecia areata is an autoimmune disorder where the immune system attacks the hair follicles, causing hair loss. Igor Novakovic/Getty Images

There is currently no cure for alopecia areata, although there are some forms of treatment that can be suggested by doctors to help hair re-grow more quickly.


The most common form of alopecia areata treatment is the use of corticosteroids, powerful anti-inflammatory drugs that can suppress the immune system. These are mostly commonly administered through local injections, topical ointment application, or orally.


Other medications that can be prescribed that either promote hair growth or affect the immune system include Minoxidil, Anthralin, SADBE, and DPCP. Although some of these may help with the re-growth of hair, they cannot prevent the formation of new bald patches.


The use of photochemotherapyTrusted Source is supported by some studies and presents a potential alternative for patients unable or unwilling to use systemic or invasive therapies.


In addition to its aesthetic aspect, hair affords a degree of protection against the elements. People with alopecia areata who miss the protective qualities of hair may wish to:


Wear sunscreen if exposed to the sun.

Wear wraparound glasses to protect the eyes from the sun and debris which the eyebrows and eyelashes would normally defend against.

Use headwear such as hats, wigs, and scarves to protect the head from the sun or keep it warm.

Use ointment inside the nose to keep membranes moist and to protect against organisms that are normally trapped by nostril hair.

Alopecia areata does not directly make people sick, nor is it contagious. It can, however, be difficult to adapt to emotionally. For many people, alopecia areata is a traumatic disease that warrants treatment addressing the emotional aspect of hair loss, as well as the hair loss itself.


Support groups and counseling are available for people to share their thoughts and feelings, and to discuss common psychological reactions to the condition.


Some have compared alopecia areata to vitiligo, an autoimmune skin disease in which the body attacks melanin-producing cells, leading to white patches. Research suggests that these two conditions may share a similar pathogenesis, with similar types of immune cells and cytokines driving the diseases and common genetic risk factors.


As such, any new developments in the treatment or prevention of either disease may have consequences for the otherTrusted Source.


There have been a handful of documented cases where treatment for alopecia areata using diphencyprone (DCP), a contact sensitizer, has led to the development of vitiligo.


Preliminary research in animals has found that quercetin, a naturally occurring bioflavonoid found in fruits and vegetables, can protect against the development of alopecia areata and effectively treat existing hair loss.


Before people can consider quercetinTrusted Source a treatment for alopecia areata, scientists need to do more research.



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The condition occurs when white blood cells attack the cells in hair follicles, causing them to shrink and dramatically slow down hair production. It is unknown precisely what causes the body’s immune system to target hair follicles in this way.


While scientists are unsure why these changes occur, it seems that genetics are involved as alopecia areata is more likely to occur in a person who has a close family member with the disease. One in five people with the disease has a family member who has also developed alopecia areata.


Other research has found that many people with a family history of alopecia areata also have a personal or family history of other autoimmune disorders, such as atopy, a disorder characterized by a tendency to be hyperallergic, thyroiditis, and vitiligo.


Despite what many people think, there is very little scientific evidence to support the view that alopecia areata is caused by stress. Extreme cases of stress could potentially trigger the condition, but most recent research points toward a genetic cause.



Research data on race and ethnicity

Alopecia areata usually causes hair loss in a circular pattern. It can occur in patches all over the head. Science Photo Library / Alamy Stock Photo

In the past, people believed that alopecia areata occurred equallyTrusted Source across all races, but more recent studies suggest that this may not be true.


For example, some findings suggestTrusted Source that African Americans and Hispanic females have a greater lifetime occurrence of the condition, when compared with white females. Additionally, there is a lower risk in Asian people, compared with white people.


According to a 2019 study based on an analysis of over 11,000 cases in the National Alopecia Areata Registry between 2000 and 2016, the odds ratios of an alopecia areta diagnosis for People of Color when compared to white people.


1.77 for African American people

1.27 for other races, including Native Americans and Pacific Islander people

1 for white people

.9 for Hispanic people

.4 for Asian people

Based on a 2018 cross-sectional analysis from the Nurses’ Health Study (NHS) and Nurses’ Health Study II (NHSII) of over 1,100 women who reported a diagnosis of alopecia areata, compared to 1.00 odds for white women, the odds for a diagnosis for Black women were 2.72 per the NHS and 5.48 per the NHSII.


For Hispanic women, the odds were 1.94 compared to white women, based on the NHSII. There were no significant incidence differences based on the NHS.


But only a few studies have examined the patterns and determinants of alopecia, and pathophysiological factors are largely unexplored. Further research is warranted that takes into consideration environmental, behavioral, genetic, and socioeconomic factors as well as access to healthcare.


Home remedies

As conventional treatments for alopecia are extremely limited, studies that support natural treatments for alopecia are even thinner on the ground.


There are some people that recommend rubbing onion or garlic juice, cooled green tea, almond oil, rosemary oil, honey, or coconut milk into the scalp. While none of these are likely to cause harm, research does not support their effectiveness.


Some people turn to alternative treatment methods such as acupuncture and aromatherapy, although there is little, if any, evidence to support these treatments.



The most prominent symptom of alopecia areata is patchy hair loss. Coin-sized patches of hair begin to fall out, mainly from the scalp. Any site of hair growth may be affected, though, including the beard and eyelashes.


The loss of hair can be sudden, developing in just a few days or over a period of a few weeks. There may be itching or burning in the area before hair loss. The hair follicles are not destroyed and so hair can re-grow if the inflammation of the follicles subsides. People who experience just a few patches of hair loss often have a spontaneous, full recovery without any form of treatment.


About 30 percent of individuals who develop alopecia areata find that their condition either becomes more extensive or becomes a continuous cycle of hair loss and regrowth.


About half of patients recover from alopecia areata within 1 year, but many will experience more than one episode. Around 10 percent of people will go on to develop alopecia totalis or alopecia universalis.


Alopecia areata can also affect the fingernails and toenails, and sometimes these changes are the first sign that the condition is developing. There are a number of small changes that can occur to nails:


pinpoint dents appear

white spots and lines appear

nails become rough

nails lose their shine

nails become thin and split

Additional clinical signs include:


Exclamation mark hairs: This occurs when few short hairs that get narrower at their bottom and grow in or around the edges of bald spots.

Cadaver hairs: This is where hairs break before reaching the skin surface.

White hair: This may grow in areas affected by hair loss.



Alopecia areata is not limited to the scalp and can include areas such as the beard. VioletaStoimenova/Getty Images


Doctors are usually able to diagnose alopecia areata fairly easily by examining symptoms. They might look at the degree of hair loss and examine hairs from affected areas under a microscope.


If, after an initial clinical examination, the doctor is not able to make a diagnosis, they can perform a skin biopsy. If they need to rule out other autoimmune diseases, they might perform a blood test.


As the symptoms of alopecia areata are so distinctive, making a diagnosis is usually quick and straightforward.


Last medically reviewed on April 7, 2022







Author: Thavocalist

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