Deuruxolitinib yields hair growth, satisfaction in patients with alopecia areata
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Key takeaways:
- A higher proportion of patients who received deuruxolitinib achieved the primary endpoint.
- Satisfaction was reported by 42.1% and 53% in the deuruxolitinib groups vs. 4.7% in the placebo group.
Patients with alopecia areata who were treated with deuruxolitinib experienced significant hair regrowth and reported satisfaction, according to a study.
“The clinical implications of deuruxolitinib are that we have a third medicine 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 failure of one JAK inhibitor does not mean that a patient will not succeed with another one.”
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 medication for severe alopecia areata.
The approval was supported by results from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, and two open-label long-term extension trials.
Results from THRIVE-AA1 were recently published in the Journal of the American Academy of Dermatology, with the efficacy and safety of deuruxolitinib evaluated in patients aged 18 to 65 years with 50% or more hair loss from 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 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).
Satisfaction of hair patient-reported outcome was 42.1% and 53% in the deuruxolitinib 8 mg and 12 mg groups, respectively, vs. 4.7% in the placebo group.
Treatment-emergent adverse events were consistent with other oral JAK inhibitors and reported by 65.1% and 63.7% of patients in the deuruxolitinib 8 mg and 12 mg groups, respectively, and 55.7% in the placebo group. Two serious treatment-emergent adverse events related to the study drug occurred in one patient who received deuruxolitinib 8 mg. No deaths were reported.
“Having deuruxolitinib in our toolbox means that more patients with severe alopecia areata will be successfully treated,” King said.