Brett King, MD: Deuruxolitinib Approval and the 'Golden Age' of Alopecia Areata

The US Food and Drug Administration’s approval of deuruxolitinib (Leqselvi) for severe alopecia areata is significant for the dermatology community on multiple fronts.

The new addition to the armamentarium is welcomed with open arms, especially considering the community was without any approved therapies just 3 years ago. Now, for 3 consecutive summers, the community has welcomed the approval of agents boasting indications for alopecia areata, with baricitinib in (Olumiant) in 2022 followed by ritlecitinib (Litfulo) in 2023.^1,2,3

Now the addition of a third FDA-approved JAK inhibitor in deuruxolitinib provides an additional option for those who may have failed to achieve treatment goals with a previous JAK therapy. It also serves as a reminder of the community’s continued fervor to provide options and choices for patients with dermatologic conditions.^1,2,3

“We’re coming from a time where, before, there was nothing,” explained Brett King, MD, PhD, associate professor of Dermatology in the Department of Dermatology at Yale University School of Medicine, in an interview with HCPLive Dermatology. “Truly, before June 2022 there was not a single approved medicine for patients with alopecia areata. We certainly had no proven, reliably effective therapies for the treatment of severe alopecia areata and, now, 3 years in a row, a new agent. This is truly the golden age for patients and the people who take care of them.”

The July 2024 approval of Sun Pharma’s oral JAK inhibitor was based on data from the THRIVE-AA1 and THRIVE-AA2 trials, in which King served on as an investigator. Both trials were randomized, double-blind, placebo-controlled clinical trials and enrolled a combined 1220 adult patients aged 18 to 65 years with severe alopecia areata, which was defined as at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months.

In THRIVE-AA1, 29.6% of the 8 mg twice-daily arm and 41.9% of the 12 mg twice-daily arm achieved a SALT score of 20 or less at week 24 relative to 0.8% of patients in the placebo group (P <.0001). In THRIVE-AA2, 21% of the 8 mg twice-daily arm and 35% of the 12 mg twice-daily arm relative to 0% receiving placebo achieved a SALT score of 10 or less after 24 weeks (P <.0001).

For more on the approval and what it means for dermatologists as well as patients and their families, check out our full reaction interview with King.

Relevant disclosures for King include Pfizer, Lilly USA, Eli Lilly and Company, AbbVie, Genzyme, Incite, Dermavant, Aclaris, Otsuka, Regeneron, and others.

References:

1. Sun Pharmaceutical Industries Limited. U.S. FDA Approves LEQSELVITM (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. Sun Pharmaceutical Industries Limited. July 25, 2024. Accessed July 27, 2024. https://sunpharma.com/wp-content/uploads/2024/07/Sunpharma-LEQSELVI-Approval-Scenario-Press-Release.pdf.
2. Eli Lilly and Company. FDA approves Lilly and Incyte’s OLUMIANT® (baricitinib) as First and only systemic medicine for adults with severe alopecia areata. Eli Lilly and Company. June 13, 2022. Accessed July 27, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-first-and.
3. Pfizer. FDA Approves Pfizer’s LITFULOTM (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata. Pfizer. June 23, 2023. Accessed July 27, 2024. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and.
4. King B. Top-line results from THRIVE-AA1: A clinical trial of CTP-543 (Deuruxolitinib), an oral JAK inhibitor, in adult patients with moderate to severe alopecia areata.Paper presented at the American Society of Retina European Academy of Dermatology and VenereologyCongress. Milan, Italy. September 7 - 10, 2022.
5. Late-breaking phase 3 data at AAD 2023 show oral investigational medicine deuruxolitinib significantly improved scalp hair regrowth in alopecia areata. BioSpace. March 18, 2023. Accessed July 27, 2024. https://www.biospace.com/late-breaking-phase-3-data-at-aad-2023-show-oral-investigational-medicine-deuruxolitinib-significantly-improved-scalp-hair-regrowth-in-alopecia-areata.