Sun Pharma presented open-label extension data for 8 mg durxolitinib (Lexelvi, Sun Pharma) in adult patients with severe alopecia areata (AA) at the Fall Clinical Dermatology Congress. 1 Data presented in poster 2 provided new insights into long-term hair loss. – Demonstrate the long-term efficacy and safety of durxolitinib, further establishing its role in the management of AA.
In two pivotal Phase 3 trials, THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650), durxolitinib showed significant efficacy in promoting scalp hair regrowth, and earlier this year This led to US FDA approval as a treatment for AA. A recent study aimed to evaluate long-term outcomes in patients treated with deurxolitinib, focusing on both efficacy and safety.
This study pooled data from two open-label expansion trials that included participants who had previously completed eligible trials. The primary objective was to assess the durability of treatment response over up to 68 weeks. The researchers utilized the Severity of Alopecia Tool (SALT) score as the primary measure of efficacy, with a SALT score of 20 or less indicating a clinically meaningful improvement in hair regrowth.
Participants received durxolitinib at a dose of 8 mg twice daily (BID) or a dose of 12 mg, with the option to adjust the dose based on clinical judgment.
At the end of the first 24-week qualifying study period, 32.6% of patients receiving duurxolitinib 8 mg BID achieved a SALT score of 20 or less. This percentage increased significantly as the study progressed to week 68, with 48.8% of patients using the Last Observation Carried Forward analysis and 76.6% of patients using the As Observed analysis achieving the same SALT score.
Furthermore, of the 283 patients who initially responded to treatment, 99.6% maintained their response throughout the study, demonstrating the long-term efficacy of duurxolitinib. These findings suggest that this treatment not only promotes hair regrowth but also helps maintain that regrowth over the long term.
In addition to efficacy data, this study also provided insight into durxolitinib’s safety profile. The treatment was generally well tolerated, with a low incidence of treatment-emergent adverse events. The most common reasons for discontinuation included withdrawal of consent and loss to follow-up rather than side effects.
“This interim analysis of data pooled through 68 weeks of treatment showed continued improvement in hair regrowth, as determined by an increase in SALT 20 responders and a decrease in mean SALT scores over time.” Posted by King et al.
“As we continue to expand Sun Pharma’s dermatology portfolio, the data presented in Fall Clinical adds to the growing clinical evidence that Lexelvi is an effective treatment option for patients with severe alopecia areata. This is corroborating,” said Marek Honcharenko, MD. Sun Pharma’s senior vice president and head of global development said in a news release. 1 “We are pleased to share these important data with the dermatology community and look forward to providing patients with alopecia areata with access to this innovative treatment option.”
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References
Sun Pharma presented data for Lexervy (duurxolitinib) highlighting clinical efficacy and durability in the treatment of alopecia areata at the Fall 2024 Clinical Dermatology Conference. News release. Sun Pharma. October 25, 2024. Accessed October 25, 2024. https://www.prnewswire.com/news-releases/sun-pharma-presents-leqselvi-deuruxolitinib-data-highlighting-clinical-efficacy–durability-for-treatment- of-alopecia-areata-at-the-2024 -fall-clinical-dermatology-conference-302287597.htmlKing B, Senna MM, Mesinkovska NA, Mostaghimi A, Hamilton C, Cassella J. Deulxolitinib produces sustained clinically meaningful improvement in scalp hair. Regrowth in adults with alopecia: pooled long-term efficacy and safety data from open-label extension studies. Poster Presentation: 44th Fall Meeting of Clinical Dermatology; October 24-27, 2024. Las Vegas, Nevada.
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