SURVEY RESULTS
SEE WHAT PATIENTS ARE SAYING ABOUT OPZELURA
PHASE 3 CLINICAL TRIAL RESULTS
PRIMARY ENDPOINT: More than 1 in 2 patients achieved clear or almost clear skin (IGA 0/1) with ≥2-point improvement from baseline* at Week 8 (53.8% vs. 15.1% and 5 1.3% vs. 7.6% with vehicle†; P < 0.0001)1-3
KEY SECONDARY ENDPOINT: More than 1 in 2 patients achieved clinically meaningful improvement in itch (NRS4‡) at Week 8 (52.2% vs. 15.4% and 50.7% vs. 16.3% with vehicle†; P < 0.0001)1-3
DIFFERENCE IN ITCH NRS4 WAS OBSERVED AS EARLY AS DAY 2 POST-HOC, EXPLORATORY ANALYSIS
(NRS ≥ 4; 11.6% vs. 2.9% and 10.8% vs. 1.3%)4,5
No conclusions around efficacy should be made based on these results.
STUDY DESIGN: 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) to 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.1,6
*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.1,2
‡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 5.1,2
AD, atopic dermatitis; BSA, body surface area; IGA, Investigator's Global Assessment; IGA-TS, Investigator's Global Assessment treatment success;
NRS, numerical rating scale.
RESULTS OF AN ONLINE QUANTITATIVE SURVEY*
This survey was conducted on behalf of Incyte from March 19 to May 10, 2024. It included 95 current OPZELURA users with AD.5
96% OF PATIENTS
WISHED THEY KNEW ABOUT OPZELURA SOONER5
98% OF PATIENTS
AGREED THAT OPZELURA WAS WORTH THEIR TIME AND EFFORT5
100% OF PATIENTS
AGREED THAT OPZELURA IS EASY TO USE5
For topical use only. Not for ophthalmic, oral, or intravaginal use. Patients should apply a thin layer twice a day to affected skin areas – up to 20% BSA.1
MAJORITY OF PATIENTS
STATED THEY EXPERIENCE LESS FREQUENT AD FLARES COMPARED TO THEIR EXPERIENCE PRIOR TO STARTING OPZELURA5
MAJORITY OF PATIENTS
AGREED THAT WHEN USING OPZELURA THEY HAVE CLEARER SKIN5
MAJORITY OF PATIENTS
AGREED THAT WHEN USING OPZELURA THEY FEEL ITCH RELIEF WITHIN DAYS5
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.5
The survey covered condition and treatment background, AD disease state, OPZELURA experience, and overall OPZELURA satisfaction.5
AD, atopic dermatitis; BSA, body surface area.
