Rapid itch reduction seen with ruxolitinib cream
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In patients with atopic dermatitis, ruxolitinib cream significantly reduced itch during two phase 3 trials.
The randomized, double blind, vehicle controlled, identical design TRuE AD 1 and TRuE AD 2 studies included 1,249 patients aged 12 years or older who had AD for at least 2 years, an IGA of 2 or 3 and 3% to 20% body surface area affected.
Patients were randomly assigned 2:2:1 to receive twice daily ruxolitinib cream 0.75%, 1.5% ruxolitinib cream or vehicle for 8 weeks.
“What is interesting is there were assessments for itch using the itch numerical rating scale that were evaluated with an electronic diary that was completed by the patient in the evenings,” Shawn G. Kwatra, MD, associate professor of dermatology and director of the Itch Center at Johns Hopkins University and one of the study’s investigators, told Healio. “We were able to follow the improvements in itch over time and see how significant itch reduction was.”
Within 12 hours of first application, a reduction in itch of –0.4 and –0.5 points was reported by both ruxolitinib cream cohorts, which was a statistically significant reduction compared with vehicle, which recorded a change of –0.1 points.
At week 8, 58.3% and 65.1% of the two treatment groups experienced at least a 2-point itch reduction as measured by the NRS2, compared with 29.4% of those in the vehicle group.
A reduction of at least 4 points was achieved by 8.9% and 11.2% of the treatment groups, respectively, at day 2, compared with 2.1% of those in the vehicle group. By week 8, a 4-point reduction was reported by 41.5% and 51.5% of the ruxolitinib cohorts and 15.8% of the vehicle group.
The mean NRS score decreased throughout the study from 5.1 in the total population to 2 in the 0.75% ruxolitinib group, 1.8 in the 1.5% ruxolitinib group and 3.5 in the vehicle group at day 56.
At week 8, approximately 80% of those in either treatment cohorts had reduced itch as assessed by the VAS itch component of SCORAD, whereas 48% of the vehicle group experienced reduced itch.
“Since itch is the cardinal symptom of atopic dermatitis that drives the negative quality of life, disrupting that itch/scratch cycle is really important for any medications,” Kwatra said. “Ruxolitinib cream results in a very rapid itch relief and it is sustained for a longer period of time. It is a very helpful and much needed addition to the armamentarium for the management of patients with atopic dermatitis.”