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)

• DOI: 10.1016/j.jaad.2024.06.097
• Publication Date: 2024-07-23T16:12:46Z
• Authors: Brett King; Maryanne M. Senna; Natasha A. Mesink...; Charles Lynde; Matthew Zirwas; Catherine Maari; Vimal H. Prajapati; Sheetal Sapra; Pawel Brzewski; Lawrence Osman; Sameh Hanna; Marni C. Wiseman; Colleen Hamilton; James Cassella
• Keywords: Oral; Adult; Male; Alopecia Areata; Adolescent; Severity of Alopecia Tool; Clinical Sciences; Clinical Trials and Supportive Activities; deuruxolitinib; 610; Administration, Oral; Clinical sciences; Phase 3; Severity of Illness Index; Dose-Response Relationship; Young Adult; Double-Blind Method; Clinical Research; Humans; Janus Kinase Inhibitors; THRIVE-AA1; Patient Reported Outcome Measures; alopecia areata; Aged; Biomedical and Clinical Sciences; Dose-Response Relationship, Drug; Dermatology & Venereal Diseases; Janus Kinase 1; Middle Aged; Janus kinase (JAK) inhibitor; Treatment Outcome; 5.1 Pharmaceuticals; Patient Satisfaction; 6.1 Pharmaceuticals; Administration; Female; Drug

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.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.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.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.Further studies are required to understand longer-term safety, efficacy, and impact of treatment cessation.Both doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth.