Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials
Melinda Gooderham, Sonja Molin, Robert Bissonnette, Margitta Worm, M.N. Crépy, Luca Stingeni, Richard B. Warren, Sibylle Schliemann, Marie L. A. Schuttelaar, Silvia Mariel Ferrucci, E. Serra‐Baldrich, Jonathan I. Silverberg, Cherry Lou Balita-Crisostomo, Marie Louise Oesterdal, Ursula Plohberger, Tove Agner
Abstract
BACKGROUND: Delgocitinib cream is the only topical treatment that has been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE). OBJECTIVE: The objective of this trial was to evaluate the long-term safety and efficacy of delgocitinib cream 20 mg/g as needed for 36 weeks in adults with CHE. METHODS: In phase 3 open-label DELTA 3 (NCT04949841), patients who completed the 16-week treatment period in the DELTA 1 and 2 trials were treated on an as-needed basis with twice-daily delgocitinib cream for 36 weeks (n= 801). Patients with Investigator's Global Assessment for CHE (IGA-CHE) ≥2 received treatment until IGA-CHE ≤1 was achieved. The primary endpoint was the number of treatment-emergent adverse events. Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores. RESULTS: Delgocitinib was well-tolerated (n= 801; R = 231.1; patient years of observation = 535.7), with most frequent adverse events being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%) and HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to week 36 (30.0% and 58.6%/36.6%, respectively) among delgocitinib-treated patients in the parent trials. Among those previously treated with cream vehicle, corresponding response rates improved from DELTA 3 baseline (9.1% and 23.7%/12.0%, respectively) to week 36 (29.5% and 51.5%/35.7%). LIMITATIONS: Open-label trial. CONCLUSION: Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in patients with CHE for up to 52 weeks.