Long-Term Results Demonstrate Clinically Meaningful Improvements in Hair Regrowth Following Oral Deuruxolitinib

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Sun Pharma announced open label extension data for 8 mg deuruxolitinib (Leqselvi; Sun Pharma) in adult patients with severe alopecia areata (AA) at the Fall Clinical Dermatology Conference^.1 The data, presented in a poster,² provided new insights into the long-term efficacy and safety of deuruxolitinib, further establishing its role in the management in AA.

In 2 pivotal phase 3 trials, THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650), deuruxolitinib demonstrated significant efficacy in promoting scalp hair regrowth, leading to its US FDA approval for the treatment of severe AA in adults earlier this year. The recent studies aimed to evaluate the long-term outcomes of patients treated with deuruxolitinib, focusing on both efficacy and safety.

The studies pooled data from 2 open-label extension trials, which included participants who had previously completed qualifying trials. The primary objective was to assess the durability of treatment response over a period of up to 68 weeks. Researchers utilized the Severity of Alopecia Tool (SALT) score as the primary measure of efficacy, with a SALT score of 20 or lower indicating a clinically meaningful improvement in hair regrowth.

Participants received deuruxolitinib at a dosage of 8 mg twice daily (BID) or 12 mg BID, with the option for dose adjustments based on clinical judgment.

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. As the study progressed to week 68, this percentage increased significantly, with 48.8% of patients achieving the same SALT score using the Last Observation Carried Forward analysis and 76.6% using the As Observed analysis.

Moreover, among the 283 patients who initially responded to treatment, 99.6% maintained their response throughout the studies, indicating the long-term efficacy of deuruxolitinib. These findings suggest that the treatment not only promotes hair regrowth but also helps sustain that regrowth over time.

In addition to the efficacy data, the studies also provided insights into the safety profile of deuruxolitinib. 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 adverse effects.

"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 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, in a news release.¹ "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option."

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References

1. Sun Pharma presents Leqselvi (deuruxolitinib) data highlighting clinical efficacy & durability for treatment of alopecia areata at the 2024 Fall 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.html
2. King B, Senna MM, Mesinkovska NA, Mostaghimi A, Hamilton C, Cassella J. Deuruxolitinib results in ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata: pooled long-term efficacy and safety data from the open-label extension studies. Poster presented at: 44th Annual Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, Nevada.