- Alopecia areata is a condition that can cause hair loss.
- Federal regulators have approved the drug Olumiant for the treatment of severe alopecia areata.
- The medication can be used in place of the painful injections now sometimes prescribed.
- However, some dermatologists say they are reluctant to prescribe Olumiant to some people due to the potential for serious side effects.
Most often, this condition, which causes hair to fall out, is treated with topical treatments or steroid injections.
That might be about to change.
Olumiant may also be the first of several of these types of medications to treat this condition. Pfizer plans to file for approval on Allegro and Concert Pharmaceuticals has a medication for alopecia in a phase three clinical trial.
“Until now, our ability to treat alopecia has been limited to topical and injectable steroids. Injectable steroids, while effective, are incredibly painful,” said Dr. Brian Toy, an attending dermatologist at Providence Mission Hospital and a clinical professor in the School of Medicine at the University of Southern California. “But with this landmark approval of Olumiant, dermatologists are now able to treat alopecia areata with a pill.”
“This is an exciting development, especially for those with widespread hair loss where hundreds of injections into the scalp and face are just not practical,” Toy told Healthline.
This drug, previously approved for some people with rheumatoid arthritis and some hospitalized patients with COVID-19, is a systemic medication. It treats the whole body instead of targeting a specific location.
Olumiant, a Janus kinase (JAK) inhibitor, is available in 2mg oral tablets and blocks the activity of one or more families of enzymes, interfering with the pathway that leads to inflammation.
The FDA approved the medication for alopecia based on two double-blind, placebo-controlled clinical trials.
In trial 1, 184 participants received 2mg of Olumiant, 281 received 5mg of the drug, and 189 received a placebo. The results showed that 22 percent of those receiving 2mg and 35 percent receiving 4mg achieved adequate scalp hair coverage compared to 5 percent receiving a placebo.
In trial 2, 156 participants received 2mg, 234 received 4mg, and 156 received a placebo. The results were similar to the first trial – 17 percent of those receiving 2mg and 32 percent of those receiving 4mg achieved adequate scalp coverage compared to 3 percent of those taking a placebo.
Olumiant has been approved for 2mg per day, increasing to 4mg per day if needed.
The most common side effects include:
- Upper respiratory tract infections
- Elevated cholesterol
- Increase in creatinine phosphokinase
- Urinary tract infection
- Elevation of liver enzymes
- Lower respiratory infections
- Genital yeast infections
- Abdominal pain
- Weight gain
The FDA approved the medication with a black box warning. It states:
“Serious Infections: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death.”
Dr Suzanne Friedler, FAAD, a dermatologist with Advanced Dermatology PC, sees this medication as best for younger and healthier patients.
“Older patients tend to have more comorbidities and heart disease, which can result in complications and severe side effects,” she told Healthline. “Anyone starting this medication should know the side effects and contact their doctor should symptoms appear. They should have regular office visits with their prescribing doctor.”
Despite approval by the FDA, some doctors are still hesitant to prescribe Olumiant.
“This would not be my first choice of medications to treat alopecia. Alternative treatments, associated risks, and potential complications must be considered when making the final therapeutic decision,” Dr. Ken L Williams Jr, FISHRS, ABHRS, a surgeon and founder of Orange County Hair Restoration and author of “Hair Transplant 360-Follicular Unit Extraction,” told Healthline.
“The potential side effects limit its use. Advance forms of alopecia are more difficult emotionally for patients. Consideration of this medication for these patients might be warranted,” he added.
Alopecia is an autoimmune disorder that causes the immune system to attack hair follicles, causing hair to fall out, sometimes in clumps.
“It affects between 2 and 3 million people and is defined by sudden hair loss that manifests with one or more circular bald patches on the scalp,” said Williams.
“It is often observed when patients experience severe stress. Most, if not all, patients with alopecia are healthy and will not suffer any serious complications or problems from this disease,” he added.
People with a family history of the condition are at a slightly higher risk of developing the disease, according to the Cleveland Clinic.
The condition most often appears during childhood or adolescence. However, it can begin at any age, according to the American Academy of Dermatology.
Hair loss can be unpredictable and may grow back within 12 months. Once it grows back, it might or might not fall out again.
Some people experience cycles of hair falling out and then regrowing. Some experience one episode and never have a second one.
There are three main types of alopecia areata:
The most common treatment for mild and localized alopecia is intralesional corticosteroid injections.
Steroid medicine is injected into the area where hair fell out, according to Yale Medicine. The steroids suppress the immune system, allowing hair regrowth.
“Injections can be problematic for people with widespread symptoms. It isn’t practical to give injections in large areas without hair or in several locations on the body, such as alopecia totalis or universalis. These patients would benefit from oral medications. People with needle phobias are another group that would benefit,” said Friedler.
Another treatment is the topical application of squaric acid or other irritants. These treatments result in a rash, disrupting the immune system’s attack on the hair follicles. This treatment is often the last resort as it can be unpleasant and cause discomfort.
“Patients suffering from alopecia areata should consult their dermatologist to discuss the pro and cons of taking baricitinib,” said Toy. “The elephant in the room is whether insurance plans will cover this drug, with a list price of approximately $5,000 per month for the 4 mg dose. Insurance carriers have a long history of denying medical coverage for alopecia areata, which some consider a ‘cosmetic’ condition. Alopecia areata, however, is an autoimmune disease that is very different from male pattern baldness. Ask any patient with alopecia areata and they will tell you how devastating it really is.”