Incyte announces new data from Phase 3 TRuE-AD3 study of ruxolitinib cream

Incyte announced expanded results from the pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream in children with atopic dermatitis, the most common type of eczema. These data were presented in a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress 2023, held from October 11-14 in Berlin. Additionally, results from a Phase 1 open-label maximum-use trial evaluating the safety and tolerability of ruxolitinib cream in children treated under maximum-use conditions over an 8-week trial period were featured as an ePoster at the EADV Congress 2023. Data from the TRuE-AD3 study, which build upon previously announced topline results, showed the study met its primary endpoint with significantly more patients treated with ruxolitinib cream achieving Investigator’s Global Assessment Treatment Success than patients treated with vehicle control. IGA-TS is defined as an IGA score of 0 or 1 with at least a two-point improvement from baseline at Week 8. In addition, secondary endpoints such as time to NRS4 and patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index at Week 8 were also achieved. Additional key findings from the TRuE-AD3 study include: Fifty-six percent of patients treated with ruxolitinib cream 1.5% and 36.6% treated with ruxolitinib cream 0.75% achieved IGA-TS at Week 8 compared to 10.8% of patients treated with vehicle. More than half of patients treated with ruxolitinib cream achieved EASI75 compared to those treated with vehicle at Week 8. In patients 6 to less than12 years old, NRS4 was achieved by 43.4% and 37.5% of patients at Week 8 compared to those treated with vehicle. Median time to NRS4 was 13.0/11.0 days compared to 23.0 days for vehicle. The mean steady-state plasma concentrations of ruxolitinib at Week 8 were 23.2 nM and 11.3 nM, which are well below 281 nM, suggesting meaningful systemic JAK inhibition is highly unlikely. Ruxolitinib cream was well tolerated with no serious infections, major adverse cardiovascular events malignancies or thromboses reported during the 8-week vehicle-controlled period. The most common treatment-related adverse event observed in the ruxolitinib cream arms was application site pain. Results from the maximum-use trial in children with at least 35% of their body surface area affected by AD showed ruxolitinib cream was well tolerated, with efficacy results consistent with data from an adolescent and adult maximum-use study and a pilot pharmacokinetics/safety pediatric study. Key findings from the MUsT study include: About 20% of patients treated with ruxolitinib cream 1.5% reported treatment emergent adverse events through Week 8; none were serious or led to treatment interruption or discontinuation. No TEAEs suggestive of systemic JAK inhibition were reported. The mean Css of ruxolitinib cream through Week 4 was 98.2 nM, which is well below 281 nM, suggesting meaningful systemic JAK inhibition is highly unlikely. Approximately 54% of patients achieved an IGA of 0 or 1 and approximately 73% achieved NRS4 by Week 4. Opzelura is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.