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Severe Hair Loss Cure?

Growing hair back after severe alopecia areata

Alopecia areata is an autoimmune disorder in which the body attacks its own hair follicles. It may lead to the hair on the head falling out, a lack of eyebrows and eyelashes, and other problems such as brittle nails. It can be a difficult condition that emotionally affects people because of aesthetic and functional issues.

The first medication for the systemic treatment of this condition has recently been approved by the FDA. In June of 2022, the FDA approved Olumiant, a brand-name version of baricitinib. These are oral tablets that treat adults with severe cases of alopecia areata.

How does baricitinib work

Baricitinib is an oral JAK inhibitor. The Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway has an important role in starting and regulating immune system responses and plays a key role in inflammation. 

How was baricitinib approved?

The trials consisted of randomized double-blind and placebo-controlled conditions. These were phase 3 trials with a total of 1200 patients. The inclusion criteria were patients who had at least 50% hair loss as measured by the Severity of Alopecia Tool (SALT).
For six months, patients in these trials received a daily dose of either a placebo, two milligrams of Olumiant, or four milligrams of Olumiant. The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.

The successful endpoint was achieved in only 1% of the placebo group, 12% of patients who took Olumiant at a 2 mg dose and about 25 % of patients who took Olumiant at a 4 mg dose achieved 90% or more hair coverage.

What are the side effects of baricitinib?

Side effects of JAK inhibitors include:

  • headaches
  • acne
  • high cholesterol
  • upper respiratory tract infections
  • Ramsay Hunt syndrome (herpes zoster oticus)
  • allergic reactions
  • GI problems
  • changes to some laboratory blood values (white and red blood cell counts)
  • a higher rate of all-cause mortality
  • sudden cardiovascular death
  • Lymphoma and other malignancies 
  • Deep vein thrombosis or pulmonary embolism

Much of this has been observed in prior studies related to rheumatoid arthritis patients. Olumiant was originally approved in 2018 as a treatment for adult patients with moderately to severely active rheumatoid arthritis. When taking JAK inhibitors, rheumatoid arthritis patients who are 50 and older and have at least one cardiovascular risk factor experienced a higher rate of major adverse cardiovascular events which included death, heart attack, stroke, and thrombosis. 

Many of these adverse effects were not experienced by those taking the medication for alopecia areata. This might be because the patients were younger and healthier–the average age of patients was 37 years old. However, several patients did experience more serious adverse consequences. Serious adverse effects occurred at a rate of 2-3.4% in the treatment groups and about 1.5-1.9% in the placebo groups. In the treatment groups, one person had a major adverse cardiovascular event and one person developed a new cancer.

Who funded the study?

The trials were funded by Eli Lilly, the pharmaceutical company that manufactures, does the primary marketing for, and sells this medication. Surely they would want to show that the results are in their favor. It is in their interest to be able to sell the medication, to have it FDA-approved and to have it covered by insurance companies. This doesn't necessarily mean that the studies weren't done properly but it's important to consider the funding of the study to assess the potential for bias. 

Is baricitinib the only medication that can treat alopecia areata?

Baricitinib is currently the only medication for the systemic treatment of alopecia areata, but it is not the optimal solution for everyone.
Dr. Gary Linkov has lost his hair due to alopecia areata, but he’s thriving. Every three weeks he received allergy shots to try to retrain the immune system. He has had some eyelash and eyebrow regrowth. His nails have also gotten much stronger, which is beneficial to him as a surgeon.
With a thriving surgical practice and lots of support from the YouTube community, Dr. Linkov is doing well. He doesn't feel the need to be on baricitinib at the moment, but will more seriously consider it if he begins to have functional issues with his nails and eyelashes.

Should baricitinib be avoided? 

The medication lowers the ability of the immune system to fight infection. For this reason, Eli Lilly recommends close monitoring for the development of signs and symptoms of infection during and after treatment. They also say that patients should be evaluated for active tuberculosis infection and tested for latent tuberculosis before the treatment. 

Additional studies are needed to fully flesh out the benefits and disadvantages of baricitinib, especially with long-term use.

Q&A with Dr. Linkov 

Q: Can you take Olumiant for male pattern baldness?

A: No. Olumiant is FDA approved for the treatment of adults with severe alopecia areata. Alopecia areata is an autoimmune condition, different from male pattern baldness (androgenic alopecia).

The content of this newsletter is for entertainment and educational purposes only. This content is not meant to provide any medical advice or treat any medical conditions. Patients must be evaluated by an appropriate healthcare provider on an individual basis and treatment must be tailored to meet that patient’s needs. Results and particular outcomes are not guaranteed.

Written by Aleksandra Božović | Edited by Dr. Gary Linkov
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