Deuruxolitinib Twice-Daily Improves Hair Satisfaction Among Patients with Alopecia Areata

Arash Mostaghimi, MD, MPA, MPH

Credit: Mostaghimi Lab

Treatment of alopecia areata with twice-daily deuruxolotinib (Leqselvi) 8 mg led to 95% of patients reporting significant hair satisfaction improvement over 24 weeks, according to recent poster data presented at European Academy of Dermatology and Venereology (EADV) Congress in September 2024.¹

Several abstracts were presented by Sun Pharmaceutical Industries Limited at EADV, with findings that were presented highlighting results of this drug among patients. These studies looked at the clinical efficacy and safety of deuruxolitinib, an oral selective Janus Kinase (JAK)-1 and JAK-2 inhibitor that was previously approved by the US Food and Drug Administration (FDA) for adult patients with severe alopecia areata.²

“Deuruxolitinib targets the immune mechanisms behind alopecia areata, providing patients with an effective treatment option,” Arash Mostaghimi, MD, MPA, MPH, the vice chair of clinical trials and innovation and the director of inpatient dermatology at Brigham and Women's Hospital, said in a statement. “As a dermatologist, I find these data particularly encouraging because it addresses the physical effects of hair loss, which can, in turn, address the significant emotional and mental health challenges that patients often face.”¹

Alopecia areata is an autoimmune condition which is known to result in hair loss on patients’ scalp and body. The condition is believed to impact up to 2.5% of the population in the US and around the world.

Two key clinical trials, specifically THRIVE-AA1 and THRIVE-AA2, were presented at EADV. There were 1,223 adult participants with severe alopecia areata across sites found in Canada, the US, and Europe. All subjects participating in the trials reported having at least 50% scalp hair loss.¹

These randomized, placebo-controlled, double-blinded studies assessed the appearance of scalp hair regrowth following 24 weeks of treatment. The THRIVE-AA1 and AA2 investigators used the Severity of Alopecia Tool (SALT) score for their evaluations of study subjects.

Participants were given random assignment to either the treatment arms of the study, given either 8 mg or 12 mg of deuruxolitinib twice-per-day, or they were assigned to the placebo arm. The research team’s primary aim was achievement of a SALT score of 20 or lower among participants by the 24-week mark.

In the announcement of the findings, the presenters noted that a SALT score of 100 would suggest complete scalp hair loss, and a score of 0 would suggest zero hair loss. The average SALT scores at the point of baseline SALT scores for subjects featured in the THRIVE-AA1 and THRIVE-AA2 trials were noted as being approximately 85.9 and 87.9, respectively.

In total, among the presentations given at EADV, there were 3 abstracts included in Sun Pharma’s announcement which featured data from studies involving deuruxolitinib. These included THRIVE-AA1 and AA2.

Among the notable findings of this set of research, 95% of individuals who were in the twice-daily 8 mg deuruxolitinib cohort, reported significant improvements in their ratings of hair satisfaction over the course of 24 weeks of therapy.

The presenters of this finding noted this as an outcome of value, given the fact that many patients with this hair loss condition face issues with depression and anxiety. This is especially known to be present among such patients given the visible nature of their condition.

The presenters noted that Sun Pharma presented 2 additional posters on deuruxolitinib’s positive effect on mental health conditions among patients with severe cases of alopecia areata. These posters also highlighted data on dose optimization for the 8 mg therapy regimen.

References

1. ^{Sun Pharma Presents New Clinical Efficacy and Safety Data in Severe Dermatological Conditions at the 2024 European Academy of Dermatology and Venereology (EADV) Congress. https://sunpharma.com/wp-content/uploads/2024/09/Press-Release-new-clinical-efficacy-and-safety-data-present-at-the-2024-EADV-Congress.pdf. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September.}
2. ^{U.S. FDA Approves LEQSELVI™ (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. Sun Pharmaceutical Industries Limited. July 26, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207625.html. Date accessed: September 30, 2024.}