12 August 2024
2 minutes reading time
Key findings:
- A higher proportion of patients receiving deuruxolitinib achieved the primary endpoint.
- Satisfaction was reported by 42.1% and 53% of the deuruxolitinib groups, respectively, compared to 4.7% in the placebo group.
According to one study, patients with alopecia areata treated with deuruxolitinib experienced significant hair regrowth and reported satisfaction.
“The clinical significance of deuruxolitinib is that we now have a third drug for this not uncommon disease,” Brett King, MD, PhD, associate professor of dermatology at Yale University School of Medicine and a member of Healio Dermatology’s Peer Perspective Board, told Healio, “This is important because the failure of one JAK inhibitor does not mean that another will not be successful in a patient.”
As Healio previously reported, Leqselvi (deuruxolitinib, Sun Pharma) 8 mg tablets, a twice-daily oral selective Janus kinase (JAK)-1 and -2 inhibitor, was recently approved by the FDA as the third systemic drug for severe alopecia areata.
Brett King
The approval was supported by results from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, as well as two open-label long-term extension studies.
The results of THRIVE-AA1 were recently published in Journal of the American Academy of Dermatologyto evaluate the efficacy and safety of deuruxolitinib in patients aged 18 to 65 years with 50% or more hair loss due to alopecia areata.
Each patient was randomly assigned to receive deuruxolitinib 8 mg twice daily (n = 351), deuruxolitinib 12 mg twice daily (n = 215), or placebo (n = 140) for 24 weeks.
A significantly higher proportion of patients in the deuruxolitinib groups achieved the primary endpoint of a Severity of Alopecia Tool score of 20 or less compared with placebo (29.6% for 8 mg and 41.5% for 12 mg vs. 0.8% for placebo).
Patient-reported satisfaction with hair outcomes was 42.1% and 53% in the deuruxolitinib 8 mg and 12 mg groups, respectively, versus 4.7% in the placebo group.
Treatment-emergent adverse events were consistent with those seen with other oral JAK inhibitors and were reported by 65.1% and 63.7% of patients in the deuruxolitinib 8 mg and 12 mg groups, respectively, and by 55.7% in the placebo group. Two serious treatment-emergent adverse events related to study drug occurred in one patient receiving deuruxolitinib 8 mg. No deaths were reported.
“Having deuruxolitinib in our armamentarium means that more patients with severe alopecia areata can be successfully treated,” King said.
Sources/Disclosures
collapse
Announcement: King reports serving as a consultant, expert witness, investigator, or speaker for AbbVie, Almirall, AltruBio, AnaptysBio, Arena Pharmaceuticals, BiologicsMD, Bioniz Therapeutics, Bristol-Myers Squibb, Concert Pharmaceuticals, Eli Lilly, Equillium, Horizon Therapeutics, Incyte, Janssen Pharmaceuticals, Leo Pharma, Otsuka/Visterra, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharmaceutical Industries, TWi Biotechnology, and Viela Bio.
