Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1)

J Am Acad Dermatol. 2024 Nov;91(5):880-888. doi: 10.1016/j.jaad.2024.06.097.

Brett King ¹, Maryanne M Senna ², Natasha A Mesinkovska ³, Charles Lynde ⁴, Matthew Zirwas ⁵, Catherine Maari ⁶, Vimal H Prajapati ⁷, Sheetal Sapra ⁸, Pawel Brzewski ⁹, Lawrence Osman ¹⁰, Sameh Hanna ¹¹, Marni C Wiseman ¹², Colleen Hamilton ¹³, James Cassella ¹³

Affiliations

1 Department of Dermatology, Yale School of Medicine, New Haven, Connecticut. Electronic address: brett.king@yale.edu.
2 Department of Dermatology, Lahey Hair Loss Center of Excellence, Lahey Hospital and Medical Center, Burlington, Massachusetts.
3 Department of Dermatology, University of California, Irvine, California.
4 Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Lynderm Research Inc., Probity Medical Research, Markham, Ontario, Canada.
5 DOCS Dermatology, Columbus, Ohio.
6 Faculty of Medicine, Department of Medicine, University of Montreal, Montreal, Quebec, Canada.
7 Division of Dermatology, Department of Medicine, and Sections of Community Pediatrics and Pediatric Rheumatology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada; Dermatology Research Institute, Probity Medical Research, Skin Health & Wellness Centre, Calgary, Alberta, Canada.
8 Institute of Cosmetic and Laser Surgery, Oakville, Ontario, Canada.
9 Department of Dermatology, Jagiellonian University, Krakow, Poland.
10 Quest Dermatology Research, Northridge, California.
11 Department of Medicine, Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; Dermatology On Bloor, Toronto, Ontario, Canada.
12 Section of Dermatology, Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
13 Sun Pharmaceutical Industries, Inc., Lexington, Massachusetts.

PMID: 39053611 DOI: 10.1016/j.jaad.2024.06.097

Abstract

Background: Alopecia areata (AA) is a hair loss disorder that can seriously impact quality of life. Janus kinase (JAK) inhibitors, including deuruxolitinib, have previously demonstrated significant hair regrowth in AA.

Objective: The Phase 3 THRIVE-AA1 randomized, double-blinded, placebo-controlled trial (NCT04518995) evaluated the safety and efficacy of the oral JAK1/JAK2 Inhibitor deuruxolitinib in adult patients with AA.

Methods: Patients aged 18-65 years with ≥50% hair loss were randomized to deuruxolitinib 8 mg twice daily, deuruxolitinib 12 mg twice daily, or placebo for 24 weeks. The primary end point was the percentage of patients achieving a Severity of Alopecia Tool score ≤20. A key secondary end point was the percentage of satisfaction of hair patient-reported outcome responders.

Results: Significantly higher proportions of patients taking deuruxolitinib met the primary end point (8 mg 29.6%; 12 mg 41.5% versus placebo 0.8%). Both deuruxolitinib doses achieved significant improvements in all secondary end points versus placebo, including satisfaction of hair patient-reported outcome (8 mg 42.1%; 12 mg 53.0% versus placebo 4.7%). Most treatment-emergent adverse events were mild or moderate, consistent with Other oral JAK inhibitors.

Limitations: Further studies are required to understand longer-term safety, efficacy, and impact of treatment cessation.

Conclusion: Both doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth.

Keywords

Janus kinase (JAK) inhibitor; Phase 3; Severity of Alopecia Tool (SALT); THRIVE-AA1; alopecia areata; deuruxolitinib.

Products

Cat. No.

Product Name

Description

Target

Research Area
HY-50856S

Deuruxolitinib

99.18%, JAK1/2 Inhibitor

JAK

Inflammation/Immunology

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