RELIEF
REIMAGINED
JAK INHIBITION IN A TOPICAL.1 IMAGINE THAT.
JAK, Janus kinase.
#1 PRESCRIBED JAK INHIBITOR
FOR AD BY DERMATOLOGISTS AND ALLERGISTS2
>3 YEARS OF REAL-WORLD UTILIZATION3*
>0 PATIENTS TREATED4†
>0 UNIQUE PRESCRIBERS5†
…and counting
JAK, Janus kinase.
MORE THAN 1 IN 2 PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN (IGA 0/1)
with ≥2-point improvement from baseline‡ at Week 8 (primary endpoint; IGA-TS: 53.8% vs. 15.1% and 51.3% vs. 7.6% with vehicle§; P < 0.0001)1,6,7
MORE THAN 1 IN 2 PATIENTS ACHIEVED CLINICALLY MEANINGFUL IMPROVEMENT IN ITCH (NRS4||)
at Week 8 (secondary endpoint; 52.2% vs. 15.4% and 50.7% vs. 16.3% with vehicle§; P < 0.0001)1,6,7
DIFFERENCE IN ITCH NRS4 RESPONSE SEEN AS EARLY AS DAY 2
POST-HOC, EXPLORATORY ANALYSIS
(NRS ≥ 4; 11.6% vs. 2.9% and 10.8% vs. 1.3%)8,9
No conclusions around efficacy should be made based on these results.
52-WEEK ADVERSE EVENT DATA
Adverse event data from 8 weeks and 52 weeks of application (8 weeks of continuous BID application plus 44 weeks of as-needed BID application)1,10
OPZELURA was studied in 2 identically designed, double-blind, randomized, vehicle-controlled trials (TRuE-AD1 and TRuE-AD2). The 2 studies included 1249 adult and pediatric patients ≥12 years of age with an affected BSA of 3% to 20% and an IGA score of 2 (25% of patients) or 3 (75% of patients) on a severity scale of 0 to 4. Patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks. Eligible patients could continue treatment for an additional 44 weeks in an extension period where OPZELURA was applied to AD areas twice daily as needed. Patients were instructed to stop treatment 3 days after lesion clearance and restart at the first sign of recurrence.1,10
*Postmarketing use since initial approval in September 2021.3
†Across all FDA-approved indications.4,5
‡Measured by IGA-TS, defined as the achievement of clear (IGA 0) or almost clear (IGA 1) skin with at least a 2-point improvement from baseline; IGA is assessed on a severity scale of 0 to 4.1
§In TRuE-AD1 and TRuE-AD2, respectively.1,6
||Itch NRS4 is defined as the achievement of at least a 4-point improvement in daily itch on a 0- to 10-point scale, considered a clinically meaningful response. Patients in the analysis had an NRS score ≥4 at baseline; mean NRS score at baseline was 5.1,6
AD, atopic dermatitis; BID, twice daily; BSA, body surface area; IGA, Investigator’s Global Assessment; IGA-TS, Investigator's Global Assessment treatment success; NRS, numerical rating scale.
“WORTH IT"
An online quantitative survey* was conducted on behalf of Incyte from March 19 to May 10, 2024 including 95 current OPZELURA users with AD.9
According to the 95 AD patients,
98% OF PATIENTS AGREED THAT OPZELURA WAS WORTH THEIR TIME AND EFFORT9
Data were self-reported and outcomes may vary. No conclusions of safety or efficacy should be made based on these results.
Limitations: This survey relied on self-reported data, was not confirmed by a medical professional, and can be affected by bias from selection, recall, response styles, and other sources. Opinions may not be representative of the general population.
*Participants with AD reported they: had received an AD diagnosis; had been using OPZELURA for ≥2 weeks; were current or former users of topical corticosteroids and/or non-steroidal creams.9
The survey covered condition and treatment background, AD disease state, OPZELURA experience, and overall OPZELURA satisfaction.9
AD, atopic dermatitis.
HELP GET PATIENTS STARTED ON OPZELURA
>80% OF COMMERCIALLY INSURED LIVES COVERED NATIONALLY.*
Visit Opzelura On Trac™ to get tips and resources to help streamline prior authorization.
Covered at any tier, PA and other restrictions may apply. Coverage is plan specific and subject to change.
*Data from Fingertip Formulary as of January 2025 and subject to change without notice.
