March 20, 2023
1 min read
Source/Disclosures
Published by:
King B. Results from Thrive-Aa2: A double blind, placebo-controlled phase 3 clinical trial of deuruxolitinib (Ctp-543), an oral JAK inhibitor, In adult patients with moderate to severe alopecia areata. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
Disclosures:
King reports having financial relationships with AbbVie, AnaptysBio, Arena Pharmaceuticals, BiologicsMD, Bristol Myers Squibb, Concert Pharmaceuticals, Eli Lilly and Company, Equillium Inc., Horizon Pharma Inc., Incyte Corporation, Janssen Pharmaceuticals Inc., Regeneron, Sanofi Genzyme and Twi Biotechnology Inc.
Key takeaways:
- Of deuruxolitinib-treated patients, 33% receiving 8 mg and 38% receiving 12 mg achieved the primary endpoint.
- Deuruxolitinib was well tolerated among patients.
NEW ORLEANS — A second phase 3 trial of deuruxolitinib confirmed the efficacy and tolerability of the drug in adults with moderate to severe alopecia areata, according to a study presented at the American Academy of Dermatology Annual Meeting.
Data was presented from the double-blind, placebo-controlled phase 3 clinical trial, THRIVE-AA2, evaluating deuruxolitinib (CTP-543, Concert Pharmaceuticals), an oral Janus kinase (JAK) inhibitor, for the treatment of moderate to severe alopecia areata in adults.
Patients with a 50% or greater hair loss were randomly assigned to receive 8 mg deuruxolitinib (n = 258), 12 mg deuruxolitinib (n = 129) or placebo (n = 130) twice a day. The Severity of Alopecia Tool (SALT) was used to track treatment efficacy with the primary endpoint being a proportion of patients achieving a score of 20 or less at week 24, which indicates 20% or less hair loss.
Brett King
“Both doses of deuruxolitinib achieved the primary endpoint,” Brett King, MD, PhD, FAAD, of the department of dermatology at Yale University School of Medicine in New Haven, Connecticut, said during his presentation at a late-breaker session.
Specifically, 33% of the 8 mg treatment group and 38% of the 12 mg treatment group achieved the primary endpoint. This was in comparison with 1% of the placebo group.
Similarly, 21% of patients treated with 8 mg and 35% treated with 12 mg achieved SALT scores less than or equal to 10, which was not achieved by any patients in the placebo group. These results may demonstrate that increased dosages of deuruxolitinib increase efficacy, according to King.
A total of 46.4% and 51.7% of patients were satisfied or very satisfied with their results in the 8 mg and 12 mg groups, respectively.
Deuruxolitinib was well tolerated in both doses. Of five serious adverse events reported, only pneumonia influenza was considered related to treatment.
Overall, the results of this trial have confirmed the consistently high efficacy level of deuruxolitinib in the treatment of alopecia areata, with improvement being seen as early as 4 weeks.
“This is why there is so much excitement about JAK inhibitors,” King said. “We are transforming lives forever.”
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