Incyte’s Ruxolitinib Cream demonstrates promising efficacy in TRuE-AD3 study

Incyte (Nasdaq:INCY), an esteemed biopharmaceutical giant, has unveiled compelling expanded findings from its Phase 3 TRuE-AD3 study on the ruxolitinib cream (Opzelura) for treating children (aged ≥2 to <12 years) with atopic dermatitis (AD), the predominant form of eczema. These critical data points were spotlighted in an influential oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin. Also featured was an ePoster detailing results from a Phase 1 trial focusing on the cream’s safety under maximum-use conditions for the same age group.

Reinforcing previously released top-line findings, the TRuE-AD3 study met its principal objectives. A notably larger percentage of subjects using ruxolitinib cream achieved the Investigator’s Global Assessment Treatment Success (IGA-TS) compared to those utilizing a non-medicated control cream. Additionally, vital secondary endpoints, including time to NRS4 and a 75% improvement in the Eczema Area and Severity Index (EASI75) by the 8th week, were satisfactorily met.

Dr. Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity at Incyte, underscored the significance of the results. “The compelling TRuE-AD3 data robustly validates the ruxolitinib cream’s profound safety and effectiveness for pediatric use,” he emphasized, further highlighting the unmet medical demand for potent nonsteroidal topical treatments addressing AD symptoms in children.

Key Insights from the TRuE-AD3 Study:

• A staggering 56.5% of participants treated with 1.5% ruxolitinib cream, and 36.6% with the 0.75% variant, reached IGA-TS by Week 8, compared to a mere 10.8% using the vehicle control.
• A significant majority, 67.2% and 51.5%, using the ruxolitinib creams (1.5% and 0.75% respectively), achieved EASI75 by Week 8, contrasted against 15.4% with the control.
• For children aged 6 to <12 years, NRS4 was reached by 43.4% (1.5% cream) and 37.5% (0.75% cream) by Week 8.
• Mean plasma concentrations of ruxolitinib at Week 8 indicated a minimal likelihood of systemic JAK inhibition.
• The ruxolitinib cream had a strong tolerability profile, with no reported major adverse effects. Minor application site pain was the most frequent minor adverse event.

Findings from the Maximum-Use Trial (MUsT):

• Only 20.7% reported treatment emergent adverse events (TEAEs) through Week 8 using 1.5% ruxolitinib cream.
• Mean ruxolitinib cream concentration up to Week 4 was well below the threshold, suggesting minimal systemic JAK inhibition.
• Approximately 54% of patients achieved an IGA score of 0 or 1, and about 73% attained NRS4 by Week 4.

Opzelura, a unique cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, stands approved by the U.S. Food & Drug Administration. Recognized as the only repigmentation treatment in the U.S., Opzelura is also greenlit for the topical treatment of mild to moderate AD in patients aged 12 and above.