Long-term data from open-label extension trials of deuruxolitinib (Leqselvi; Sun Pharma) demonstrate continued and clinically meaningful improvements in hair regrowth for adult patients with severe alopecia areata (AA). The data, presented at the Fall Clinical Dermatology Conference, provide insights into the long-term efficacy and safety of deuruxolitinib.
Deuruxolitinib, a drug developed by Sun Pharma, received FDA approval earlier this year for the treatment of severe AA in adults based on the results of two pivotal phase 3 trials, THRIVE-AA1 and THRIVE-AA2. These trials demonstrated significant efficacy in promoting scalp hair regrowth. The recent studies aimed to evaluate the long-term outcomes of patients treated with deuruxolitinib, focusing on both efficacy and safety over an extended period.
The pooled data comes from two open-label extension trials, including participants who had previously completed qualifying trials. The primary objective was to assess the durability of treatment response over 68 weeks. Researchers used the Severity of Alopecia Tool (SALT) score, where a score of 20 or lower indicates clinically meaningful improvement.
Participants received deuruxolitinib at a dosage of 8 mg twice daily (BID) or 12 mg BID, with dose adjustments permitted based on clinical judgment. The study revealed that at the end of the initial 24-week qualifying trial period, 32.6% of patients receiving deuruxolitinib 8 mg BID achieved a SALT score of 20 or lower. By week 68, this percentage significantly increased to 48.8% using the Last Observation Carried Forward analysis and 76.6% using the As Observed analysis.
Long-Term Efficacy and Safety
Notably, among the 283 patients who initially responded to treatment, 99.6% maintained their response throughout the studies, indicating the long-term efficacy of deuruxolitinib. This suggests the treatment not only promotes hair regrowth but also helps sustain that regrowth over time. The treatment was generally well-tolerated, with a low incidence of treatment-emergent adverse events. The most common reasons for discontinuation were withdrawal of consent and loss to follow-up, rather than adverse effects.
Expert Commentary
"This interim analysis of pooled data through 68 weeks of dosing showed continual improvement in hair regrowth as determined by the increase in SALT 20 responders and decrease in the mean SALT score over time," wrote the poster authors, King et al.
"As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show Leqselvi is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, senior vice president and head of Global Development at Sun Pharma.
