skin clearance results: AGES 2-11
A CLEAR DIFFERENCE FOR PATIENTS AS YOUNG AS 2 YEARS1-3
PRIMARY ENDPOINT
CLEAR OR ALMOST CLEAR RESULTS (IGA-TS*) AT WEEK 83,4
MORE THAN 50% OF PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN WITH ≥2-POINT IMPROVEMENT (IGA-TS) FROM BASELINE AT WEEK 81-3
Adapted from Kallender. Mendeley Data. 2025.
*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
BID, twice daily; IGA, Investigator’s Global Assessment; IGA-TS, Investigator’s Global Assessment treatment success.
The line graph above shows the proportion of IGA-TS responders for OPZELURA and vehicle from the TRuE-AD3 clinical trial from Week 0 to Week 8. At Week 8, 56.5% of patients taking OPZELURA achieved clear or almost clear results vs. 10.8% for vehicle. This demonstrates over 5x as many responders to OPZELURA than vehicle.3,4
LONG-TERM EXTENSION DATA
CLEAR OR ALMOST CLEAR SKIN THROUGH 52 WEEKS WITH AS-NEEDED USE OF MONOTHERAPY2
IGA* SCORES OF 0/1 THROUGH WEEK 52 (EXTENSION DATA)2
Adapted from Eichenfield et al. EADV Congress. 2024.
*IGA is assessed on a severity scale of 0 to 4.1
†Week 12-52 data excludes 1 patient in the OPZELURA group who completed the study but did not receive treatment in the LTS period (maintained IGA and BSA of 0).2
‡Vehicle group rerandomized to ruxolitinib 0.75% or OPZELURA at Week 8.2
- Data were reported as observed2
- No conclusions of safety or efficacy should be made based on these results
- OPZELURA is for short-term and non-continuous use only1
The line graph above shows the proportion of patients achieving IGA scores of 0/1 with OPZELURA at Week 52. In TRuE-AD3, 72.3% of patients on OPZELURA vs. 72.2% of patients on vehicle achieved clear or almost clear skin after switching from vehicle to OPZELURA and using as needed in the 44-week extension period.2
BID, twice daily; IGA, Investigator's Global Assessment.
BID, twice daily; IGA, Investigator's Global Assessment.
AMONG THOSE ON OPZELURA SINCE DAY 1
Patients spent 49% of the 44-week LTS periods between Weeks 8 and 52 off treatment due to lesion clearance.2,5
Data were reported as observed.
No conclusions of safety or efficacy should
be made based on these results.
AFFECTED BSA THROUGH 1 YEAR2,5
Mean affected BSA in the OPZELURA group was 11.2% at baseline and 2.9% at Week 8.5
Adapted from Eichenfield et al. EADV Congress. 2024.
Data as observed. No conclusions of safety or efficacy should be made based on these results.
*Week 12−52 data exclude 1 patient in the OPZELURA group who completed the study but did not receive treatment in the LTS period (maintained IGA and BSA of 0).2
†Vehicle group rerandomized to ruxolitinib 0.75% or OPZELURA at Week 8.2
The graph above shows the data for mean total affected BSA over 52 weeks. At Week 52, patients using OPZELURA had a mean total affected BSA of 1.9% vs. 1.6% for those who switched from vehicle to OPZELURA at Week 8. Please note that the number of patients in the extension part of the trial decreased over time.2
BID, twice daily; BSA, body surface area; LTS, long-term safety.
