Opzelura Helps Beat AD Itch

Adult AD patients treated with Opzelura experienced rapid and substantial improvement in itch, which was sustained through Day 28.

Opzelura (ruxolitinib) cream 1.5% showed substantial and rapid itch reduction in patients with mild-moderate Atopic Dermatitis (AD).

These data were featured in a poster presentation at the Revolutionizing Atopic Dermatitis (RAD) Conference, held from April 29-May 1 in Washington, D.C.

Patients with AD treated with Opzelura experienced a rapid and substantial improvement in itch, which was sustained and further improved through 28 days of treatment. Specifically, the study met its primary endpoint with Opzelura-treated patients experiencing a mean (SE) –3.4 reduction in itch from baseline at Day 2 as measured by the peak pruritus numerical rating scale (PP-NRS; an 11-point scale evaluating the peak intensity of itch over the course of 24 hours). Itch reduction was observed beginning as early as 15 minutes as measured by modified PP-NRS (a measurement for the current intensity of itch), and the change from baseline, observed at four hours after the first application of Opzelura, was 4.2 mPP-NRS.

"AD is a chronic, immune-mediated skin condition that can be difficult to manage and causes disruptive and persistent symptoms like itch that can greatly affect patients’ everyday lives," says Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte, in a news release. "We are pleased that the SCRATCH-AD results further emphasize the rapid impact of Opzelura on itch reduction and reinforce its profile as an effective, well-tolerated topical non-steroidal treatment for AD."

Additional key findings from SCRATCH-AD include:

• At 12 hours post-Opzelura application, improvement in itch was sustained, with a mean (SE) change from baseline in mPP-NRS of –3.1.
• Further improvement in itch was seen with continued Opzelura treatment, as evidenced by the mean (SE) change from baseline in PP-NRS increasing through Day 29.
• Overall improvement in AD symptoms reported with Opzelura treatment increased over time. The mean (SE) change from baseline in Investigator’s Global Assessment (IGA) score – a five-point scale measuring the overall severity of AD – on Days 8, 15 and 29 were –1.4 (0.11), –2.0 (0.13) and –2.2 (0.14), respectively.

Opzelura was well tolerated with no serious treatment-emergent adverse events (TEAEs) during the 28-day study period (n=49). All TEAEs were mild or moderate, with the most common being COVID-19 (6.1%), back pain (4.1%), headache (4.1%), nasopharyngitis (4.1%) and upper respiratory tract infection (4.1%). One patient presented with a treatment-related TEAE (grade 1 application site acne). No patients discontinued treatment due to a TEAE.

“The intense itch caused by AD can lead to an itch-scratch cycle which increases inflammation, further damages the skin barrier and worsen symptoms,” adds Robert Bissonnette, M.D., FRCPC, lead investigator of the SCRATCH-AD study and Chief Executive Officer and Medical Director at Innovaderm Research. “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.”

About SCRATCH-AD (NCT04839380)

SCRATCH-AD is a single-site Phase 2 open-label, single-arm study evaluating the safety and efficacy of Opzelura® (ruxolitinib) cream 1.5% in adult patients (age 18 to 65 years) with atopic dermatitis (AD), with a particular focus on understanding the short-term clinical benefits of Opzelura to control pruritus (itching) and reduce AD severity.

The study enrolled 49 patients diagnosed with AD for ≥6 months, and with chronic itch related to AD for ≥3 months, who had 1%–20% affected body surface area (BSA; excluding palms, soles, scalp, genitals, and folds), an Investigator Global Assessment (IGA) of ≥2, and a peak pruritus numerical rating scale (PP-NRS) score ≥4 at baseline. The primary analysis included 46 patients in the modified intent-to-treat (mITT) population. For 28 days, patients applied Opzelura 1.5% cream twice daily (BID) approximately 12 hours apart to all lesions identified at baseline and any new lesions.

The primary endpoint is change from baseline in PP-NRS on Day 2 (24 hours after the first application of Opzelura). Secondary endpoints included change from baseline in modified PP-NRS (mPP-NRS; current itch intensity) at 15 and 30 minutes and at 1-, 2-, 4-, 6- and 12-hours post-treatment on Day 1, as well as change from baseline in PP-NRS from Days 3 through 29, change from baseline in IGA at Days 8, 15, and 29, and safety.

About Opzelura

Opzelura is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older and the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (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. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.