1. 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)
- Author
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King, Brett, Senna, Maryanne M, Mesinkovska, Natasha A, Lynde, Charles, Zirwas, Matthew, Maari, Catherine, Prajapati, Vimal H, Sapra, Sheetal, Brzewski, Pawel, Osman, Lawrence, Hanna, Sameh, Wiseman, Marni C, Hamilton, Colleen, and Cassella, James
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,5.1 Pharmaceuticals ,Humans ,Alopecia Areata ,Adult ,Male ,Middle Aged ,Double-Blind Method ,Female ,Janus Kinase Inhibitors ,Administration ,Oral ,Young Adult ,Treatment Outcome ,Aged ,Adolescent ,Severity of Illness Index ,Patient Satisfaction ,Dose-Response Relationship ,Drug ,Janus Kinase 1 ,Patient Reported Outcome Measures ,alopecia areata ,deuruxolitinib ,Janus kinase (JAK) inhibitor ,Phase 3 ,Severity of Alopecia Tool ,THRIVE-AA1 ,Dermatology & Venereal Diseases ,Clinical sciences - Abstract
BackgroundAlopecia 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.ObjectiveThe 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.MethodsPatients 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.ResultsSignificantly 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.LimitationsFurther studies are required to understand longer-term safety, efficacy, and impact of treatment cessation.ConclusionBoth doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth.
- Published
- 2024