Sun Pharma presented updates on deuruxolitinib (Lesqselvi) at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, Netherlands, highlighting its efficacy in treating adults with severe alopecia areata. Deuruxolitinib, a JAK 1/2 inhibitor, received FDA approval on July 26, 2024, based on the THRIVE-AA1 and THRIVE-AA2 phase 3 clinical trials involving 1220 patients with at least 50% scalp hair loss.
Improved Patient Satisfaction with Hair Regrowth
The THRIVE-AA1 and THRIVE-AA2 trials demonstrated that 31% of patients treated with 8 mg of deuruxolitinib twice daily achieved a SALT score of ≤20 at 24 weeks, compared to 0.8% in the placebo group. Of these responders, 95.7% reported satisfaction with their hair by week 24. Significant improvements in hair satisfaction were observed as early as week 12 (79.6%), increasing consistently through week 24 (P < 0.0001).
Reduction in Anxiety and Depression
An analysis of data from the THRIVE-AA1 and THRIVE-AA2 trials, involving 600 patients receiving 8 mg of deuruxolitinib twice daily and 267 patients receiving placebo, assessed the impact of deuruxolitinib on anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Results showed that 22.5% of the deuruxolitinib group achieved a ≥6-point improvement in the overall HADS score compared to 11.8% in the placebo group (P < 0.05). Improvements were also seen in HADS-A (18.9% vs. 10.2%) and HADS-D (26.2% vs. 14.2%) scores.
Optimal Dosing of Deuruxolitinib
A phase 2 study compared the efficacy and safety of deuruxolitinib 8 mg twice daily versus 16 mg once daily in patients with severe alopecia areata. At week 24, patients receiving 8 mg twice daily had a greater mean relative reduction in SALT score (46.4%) compared to those receiving 16 mg once a day (18.0%). More patients in the 8 mg twice daily group achieved a 75% reduction in SALT score by week 24 (31.0% vs. 10.7%). Both dosing regimens were well-tolerated, with similar incidences of treatment-emergent adverse events (TEAEs), but the twice-daily dosing demonstrated superior efficacy and was selected for phase 3 trials.
Expert Insights
Arash Mostaghimi, MD, MPH, MPA, a THRIVE-AA investigator, highlighted the significance of deuruxolitinib's efficacy in patients with severe alopecia areata. He noted that the data presented at EADV underscores the drug's impact on hair growth and patient-reported satisfaction, as well as its ability to reduce anxiety and depression. Mostaghimi also pointed out that deuruxolitinib offers physicians an additional choice for patients, potentially providing a faster response compared to other JAK inhibitors. Prior to treatment, physicians should discuss the safety and efficacy of the medication, including the black-box warning for venous thromboembolism (VTE), and evaluate the patient's risk factors for VTE.
