Navigating Challenges and Advancements in Alopecia Areata Treatment

The psychological burden of alopecia areata is a driving force behind the development of current therapeutics as well as therapeutics in the pipeline. Through their dermatology clinicians, patients with alopecia areata currently have access to ritlecitinib (Litfulo; Pfizer) and baricitinib (Olumiant; Eli Lilly and Company and Incyte), 2 oral JAK inhibitors. The FDA approved ritlecitinib for the treatment of severe alopecia areata in adult and adolescent patients aged 12 years and older in June 2023.¹ The FDA approved baricitinib for the treatment of severe alopecia in adult patients in June 2022.²

To better understand the complexities of treating alopecia areata and deciding which treatment approach is best for each patient, Dermatology Times spoke to Maryanne Makredes Senna, MD, a board-certified dermatologist at Beth Israel Lahey Health, assistant professor of dermatology at Harvard Medical School, and the founder and director of the Lahey Hair Loss Center of Excellence in Boston, Massachusetts. From advocating for patient access to FDA-approved treatments to understanding the mechanisms and impacts of new JAK inhibitors, Senna provides her expertise and shares guidance for dermatology clinicians.

Q&A With Maryanne Makredes Senna, MD

Maryanne Makredes Senna, MD

Image Credit: Harvard Medical School

Dermatology Times: Can you please discuss some of the challenges you or other physicians face when treating alopecia areata?

Senna: One of the hardest things, truly, is advocating for my patients. I spend hours upon hours writing letters of appeal to insurance agencies to try to get approval for FDA-approved treatments for my alopecia areata treatments. One of the major issues is that although the FDA label for both ritlecitinib and baricitinib do not define what “severe” alopecia areata is, payers are only willing to cover these medications if there is 50% or more scalp hair loss, yet we know that patients can have severe disease even with 30% or 40% scalp hair loss, especially if other treatments aren’t working or they have involvement of eyebrows and eyelashes. It can be a devastating disease with significant negative psychosocial effects, and it is disappointing that despite FDA approval we still have to work so hard to ensure our patients get the treatment they need.

Dermatology Times: What are the mechanisms of action of ritlecitinib and baricitinib?

Senna: Ritlecitinib is an inhibitor of TEC/JAK3. Baricitinib is a JAK1/2 inhibitor.

Dermatology Times: In your opinion, what are some of the advantages and disadvantages of both therapeutics as JAK inhibitors?

Senna: Advantages include clinical trials have shown the efficacy of both of these medications in treating severe alopecia areata patients. These medications literally change the lives of people by giving them back something that we all take for granted: looking and feeling like themselves again. Both medications have been shown to be safe in clinical trials, and especially in the case of baricitinib there is considerable favorable safety data not only in the AA population, but in rheumatoid arthritis, and even in the use of baricitinib in the pediatric population for atopic dermatitis and juvenile inflammatory arthritis in Europe. Litfulo in the US has been incredibly helpful as we did not previously have an FDA-approved medication for adolescents, and now we do as Litfulo is approved for severe AA in patients ages 12 and up. Disadvantages include the fact that unfortunately, these medications do not work for everyone.

Dermatology Times: How are these therapeutics impacting how physicians treat patients (12 years of age and older) now versus in the past?

Senna: These treatments have literally revolutionized our ability to treat this patient population. After having no meaningful, long-term treatment options, we now have a class of medications that can significantly regrow hair for patients with severe AA. Adolescence is a particularly important time of personal development and growth—when young adults and pre-teens lose their hair from AA at this time of life, it can be particularly devastating. Our ability to now have medications to treat adolescents with AA successfully has provided a critically important and effective therapeutic option where one did not exist before.

Dermatology Times: What advice do you have for physicians deciding which therapeutic is best for their patients with alopecia areata?

Senna: Both medications are effective in the treatment of severe alopecia areata. Personally, I have used them both in pediatric and adult patients with successful outcomes. Most physicians will likely prefer to choose ritlecitinib over baricitinib for adolescent patients, given that it is FDA-approved for that age group, but overall, the efficacy of these medications is quite comparable. I would urge physicians to be familiar with the side effect profile of each medication as there are small differences between the 3 (for example, 10% of patients on ritlecitinib reported diarrhea in clinical trials which is not seen with baricitinib; hypercholesterolemia is seen in a proportion of baricitinib treated patients, but this is not seen with ritlecitinib)—in some patient cases side effects like this may impact therapeutic decision making.

Dermatology Times: Do you have any closing thoughts?

Senna: A very important message is that hair is quite different from other skin conditions, and AA patients—especially those with near complete or complete scalp hair loss—need to be given time on a given medication and have the expectation that it can take up to 9 months or a year before we start to see results from a treatment. Patients and physicians should have the right expectations and know to be patient once a therapy is started because it can take time before results are seen.

References

1. FDA approves Pfizer’s LITFULO (Ritlecitinib) for adults and adolescents with severe alopecia areata. News release. Businesswire. June 23, 2023. Accessed June 26, 2024. https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata
2. FDA approves Lilly and Incyte's OLUMIANT (baricitinib) as first and only systemic medicine for adults with severe alopecia areata. News release. Eli Lilly and Company. June 13, 2022. Accessed June 26, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-first-and