Alopecia areata: remarkable regrowth rates with deuruxolitinib

After 1 year of continuous treatment with deuruxolitinib, about 60% of participants with 50–100% of hair loss at baseline achieved Severity of Alopecia Tool (SALT) scores of ≤20. In the open-label extensions of THRIVE-AA 1 and 2, the mean SALT of deuruxolitinib-treated participants was reduced from 48 at week 24 to 32 at week 52.

“Alopecia areata is an unbelievably hot topic in dermatology because we are able to do things that were never imaginable before,” Prof. Brett King (Yale University School of Medicine, CO, USA) expressed [1]. Prof. King presented long-term OLE results for deuruxolitinib.

Previously, in the phase 3 THRIVE-AA 1 and 2 trials, (NCT04518995 and NCT04797650), the agent has demonstrated significant superiority in scalp regrowth in adult patients with 50–100% scalp hair loss equalling SALT scores of 50–100. After completing phase 2 and 3 studies over 24 weeks, participants were eligible to enter 1 of the 2 ongoing OLEs: North American (NCT03898479) or European (EudraCT 2021-002365-18). The treatment with deuruxolitinib was performed twice daily at 8 mg or 12 mg. Changing between these doses was allowed during OLE according to the investigator’s choice. Together the OLE studies enrolled 1,475 participants with a mean age of 39 years, and over 60% women. The North American cohort included Black-American, Asian, Latino, and White people, which reflects the diversity seen in the US society.

After 1 year, the pooled results showed a drop in mean SALT scores from 88.3 at week 24 to 43.6 (placebo to deuruxolitinib) and from 48.4 to 31.7 (continuous deuruxolitinib). At 52 weeks, the proportions of participants who achieved a response in terms of a SALT score ≤20% in these 2 groups was 40.5% and 57.1%, whereas the respective 24-week rates had been 1.2% and 34.9%. Depending on the statistical method, in 63.6% (censored) and 45.2% (last observation carried forward) of participants receiving twice daily 8 mg of the study drug, a SALT≤20 was observed. Participants treated with 12 mg, reached SALT scores of ≤20 at 62.1% and 58.4%. “This is an unprecedented result in alopecia areata: 60% of patients at 1 year achieving complete or near complete scalp hair regrowth,” Prof. King emphasised.

Adverse events (AE) were reported in overall 81.2% of participants. However, drug interruption due to AE occurred at a rate of 20.9% and discontinuation at 1.2%. Among the AE detected in at least 5%, COVID-19 (22.8%) and acne (13.6%) were most common. At the cut-off date in November 2022, serious or opportunistic infections and malignancies were seen in 0.6% or 0.2% and 0.5%, and there were no major adverse cardiovascular events. To date, 5 cases of thrombosis have been reported, and all these participants had been on the higher dose of deuruxolitinib. Overall, the safety profile was deemed consistent with previous knowledge.

“These are truly remarkable results of treatment of patients with severe alopecia areata with 2 doses of deuruxolitinib 8 mg twice daily and 12 mg twice daily,” Prof. King stated in his conclusion.

1. 
   
   1. King B. Deuruxolitinib demonstrates significant and continual improvement in scalp hair regrowth at 52 weeks of dosing in patients with alopecia areata: Pooled efficacy results from ongoing open-label extension trials. D3T01.3F, EADV Congress 2023, 11–14 October, Berlin, Germany.

Copyright ©2023 Medicom Medical Publishers



Posted on 28 November 20232 October 2024