Robert Bissonnette, MD

Credit: Innovaderm.com

Ruxolitinib cream 1.5% significantly reduces pruritus in adult patients—aged 18 to 65—with atopic dermatitis (AD) and the rapid improvement generally continues through 28 days, according to new phase 2 trial data.¹

These new findings were the results of the SCRATCH-AD study which assessed the clinical benefits of ruxolitinib cream in the short term on both AD disease reduction and pruritus control, given the unpleasant effects of AD’s persistent itch symptoms on patients’ lives.

“I am encouraged by these results showing rapid and substantial itch reduction among AD patients treated with Opzelura, and its potential to quickly alleviate this burdensome symptom for patients,” Robert Bissonnette, MD, lead investigator of the study, said in a statement.

The phase 2 trial’s primary endpoint was achieved, as study participants treated with ruxolitinib 1.5% cream reported a mean reduction of –3.4 in itch from baseline by 2 days. The investigators used the peak pruritus numerical rating scale (PP-NRS), an 11-point scale known to assess the peak intensity of pruritus over 24 hours.

The research team reported observing reduction in itch by as early as 15 minutes, with their assessment resulting from modified PP-NRS data. Additionally, they found that the change from baseline was noted at 4 hours following the initial drug application, and it was found to be 4.2 mPP-NRS.

The team also found that the participants’ mean (SE) changes in Investigator Global Assessment (IGA) scores from the baseline on Days 8, 15, and 29 were -1.4 (0.11), -2.0 (0.13), and -2.2 (0.14) respectively.

The treatment was also found to be well tolerated and showed no serious treatment-emergent adverse events over the 28-day course of the study, with all events being mild or moderate. The top 3 most common ons were found to be COVID-19 (6.1%), back pain (4.1%), and headaches (4.1%).

The study had been a phase 2 open-label, single-arm clinical trial performed at a single site, and the investigators enrolled 49 participants who had been diagnosed with AD for a minimum of 6 months and reported chronic itch related to AD for at least 3 months.

These participants had an IGA of 2 at least, an affected body surface area (BSA) between 1% and 20% (excluding soles, genitals, scalp, palms, and folds), and a PP-NRS score of at least 4 at baseline.

Over the course of the study’s 28 days, participants applied the cream twice-per-day, around 12 hours apart, to all lesions that had been observed at baseline in addition to any new lesions.

"We are pleased that the SCRATCH-AD results further emphasize the rapid impact of (ruxolitinib) on itch reduction and reinforce its profile as an effective, well-tolerated topical non-steroidal treatment for AD," Jim Lee, MD, PhD, Group Vice President of Inflammation & AutoImmunity at Incyte, said in a statement.

The newly-announced data was presented at a poster presentation shown at the Revolutionizing Atopic Dermatitis (RAD) 2023 Annual Meeting in Washington, DC.

References

1. ^{Incyte announces results from SCRATCH-AD trial demonstrating substantial and rapid itch reduction in patients with mild-to-moderate atopic dermatitis treated with Opzelura® (ruxolitinib) cream [press release]. Business Wire. May 1, 2023. Accessed May 2, 2023. https://www.businesswire.com/news/home/20230501005479/en/Incyte-Announces-Results-from-SCRATCH-AD-Trial-Demonstrating-Substantial-and-Rapid-Itch-Reduction-in-Patients-with-Mild-Moderate-Atopic-Dermatitis-Treated-with-Opzelura%C2%AE-ruxolitinib-Cream}