Additional Data from Incyte's Phase 3 Studies of Topical Ruxolitinib

Findings from three pooled analyses of Incyte’s randomized, double-blind, vehicle-controlled phase 3 studies evaluating ruxolitinib cream add to previously published data for the investigational topical JAK1/JAK2 inhibitor for atopic dermatitis.

Presented at the AAD VMX 2021, new findings from TRuE-AD1 and TRuE-AD2 show that subjects receiving ruxolitinib cream 0.75% applied twice daily (BID) and ruxolitinib cream 1.5% BID both demonstrated greater improvement compared to vehicle in all analyzed efficacy endpoints (i.e., IGA Treatment Success; EASI-50, EASI-75, EASI-90; and at least NRS4) at Week 8, regardless of clinical characteristic subgroup.

An analysis of patients in TRuE-AD1 and TRuE-AD2 with BSA ≥10% and EASI ≥16 at baseline found higher rates of clinical responses with ruxolitinib cream versus vehicle in these patients. At Week 8, more patients achieved IGA-TS with ruxolitinib cream 0.75% and ruxolitinib cream 1.5% versus vehicle (50.0% and 59.4% versus 0%, respectively).

“We are pleased to have the opportunity to share additional analyses from the TRuE-AD program with the scientific community at AAD VMX as these data provide more insight into the needs of people living with AD and the impact ruxolitinib cream could have across patient subgroups,” says Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Specifically, the findings suggest ruxolitinib cream could be an effective treatment option for AD irrespective of patients’ pre-treatment characteristics, and may be efficacious among those with more severe disease – potentially delaying or preventing the need for systemic therapy in these patients. We look forward to furthering analyzing data from the TRuE-AD program in the hopes it will lead to a meaningful new option for patients living with this inflammatory skin condition, which can significantly impact patients’ quality of life.”

Positive topline results from the individual TRuE-AD1 and TRuE-AD2 studies were previously reported. Efficacy and safety results from a pooled analysis of TRuE-AD1 and TRuE-AD2 were also announced and presented at the 29th European Academy of Dermatology and Venereology (EADV) Congress in October 2020. The primary and secondary endpoints were met in both TRuE-AD1 and TRuE-AD2.

 “There is an urgent need for new treatment options that balance efficacy and tolerability for patients with atopic dermatitis,” says Kim Papp, MD, PhD, Founder and President of Probity Medical Research and the Coordinating Investigator for the TRuE-AD program. “I am thoroughly encouraged by findings from the TRuE-AD program, and the potential ruxolitinib cream could have for patients whose everyday lives are impacted by the itch and inflammation associated with their disease.”