Sun Pharma Reports 2-Year Deuruxolitinib Data in Severe Alopecia Areata
Key Takeaways
- Long-term data presented at EADV Congress 2026 showed a generally consistent safety profile for deuruxolitinib through up to 2 years of open-label treatment in adults with severe alopecia areata.
- Among patients who had achieved a SALT score of 20 or less and maintained response at Week 52, 93.9% maintained response through Week 108; among baseline nonresponders who responded by Week 52 and continued treatment, 96.8% maintained response at Week 108.
- Interpretation of the Week 108 efficacy results requires consideration of the open-label extension design and enrichment of the later study population because only Week 52 responders continued beyond that point.
Long-term treatment with deuruxolitinib (LEQSELVI, Sun Pharmaceutical Industries Limited) showed sustained scalp hair response through Week 108 among selected responders with severe alopecia areata (AA), according to open-label extension (OLE) data presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.
Deuruxolitinib is a Janus kinase inhibitor administered at the US Food and Drug Administration (FDA)-approved dosage of 8 mg twice daily for eligible adults with severe AA.
Long-Term Deuruxolitinib Safety and SALT Responses
In the European OLE study, the safety profile through up to 2 years of treatment was generally consistent with previous clinical experience, according to Sun Pharma. Most treatment-emergent adverse events were mild or moderate, and discontinuations because of adverse events were uncommon. No deaths, thrombosis, or major adverse cardiovascular events were reported among patients receiving 8 mg twice daily.
Efficacy analyses assessed scalp hair regrowth using the Severity of Alopecia Tool (SALT), in which a score of 100 indicates complete scalp hair loss and 0 indicates no scalp hair loss.
Among OLE baseline responders with SALT scores of 20 or less who maintained response at Week 52 and continued treatment, 93.9% maintained response at Week 108. Among baseline nonresponders with SALT scores greater than 20, 76.6% achieved response by Week 52. Only Week 52 responders continued thereafter; among those patients, 96.8% maintained response through Week 108.
“Collectively, these data show durable efficacy and maintenance of response for deuruxolitinib over time,” said Arash Mostaghimi, MD, MPA, MPH, FAAD, of Brigham and Women’s Hospital.