SKIN CLEARANCE AND AFFECTED BSA AT WEEK 52
PATIENTS ACHIEVING IGA SCORES OF 0/1 THROUGH WEEK 521
PATIENTS ACHIEVING IGA SCORES OF 0/1 THROUGH WEEK 521
*IGA is assessed on a severity scale of 0-4.2
BSA=body surface area; IGA=Investigator’s Global Assessment.
>70% of patients had clear or almost clear skin with as-needed use of OPZELURA at week 521
- More patients achieved an IGA score of 0 or 1 after switching from vehicle to OPZELURA in the 44-week extension period1*
>70% of patients had clear or almost clear skin with as-needed use of OPZELURA at week 521
- More patients achieved an IGA score of 0 or 1 after switching from vehicle to OPZELURA in the 44-week extension period1*
- Data were reported as observed1
- No conclusions of safety or efficacy should be made based on these results
- Number of patients in each study arm are displayed below the graph for each study visit
- OPZELURA is for short-term and non-continuous use only2
*IGA is assessed on a severity scale of 0-4.2
BSA=body surface area; IGA=Investigator’s Global Assessment.
Learn about dosing and administration >
References: 1. Papp K, Szepietowski JC, Kircik L, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. Presented at: Revolutionizing Atopic Dermatitis Virtual Conference; June 13, 2021. 2. Opzelura. Prescribing Information. Incyte Corporation; 2022.
AFFECTED BSA REDUCTION THROUGH WEEK 521
AFFECTED BSA REDUCTION THROUGH WEEK 521
BSA=body surface area.
Mean total affected BSA was reduced in patients who switched from vehicle to OPZELURA in the 44-week extension period1
Mean total affected BSA was reduced in patients who switched from vehicle to OPZELURA in the 44-week extension period1
- Data were reported as observed1
- No conclusions of safety or efficacy should be made based on these results
- Number of patients in each study arm are displayed below the graph for each study visit
- OPZELURA is for short-term and non-continuous use only2
BSA=body surface area.
Learn about dosing and administration >
References: 1. Papp K, Szepietowski JC, Kircik L, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. Presented at: Revolutionizing Atopic Dermatitis Virtual Conference; June 13, 2021. 2. Opzelura. Prescribing Information. Incyte Corporation; 2022.
DISEASE CONTROL (IGA) THROUGH WEEK 521
- Data were reported as observed1
- No conclusions of safety or efficacy should be made based on these results
- Number of patients in each study arm are displayed below the graph for each study visit
*IGA is assessed on a severity scale of 0-4.2
BSA=body surface area; IGA=Investigator’s Global Assessment.
AFFECTED BSA REDUCTION THROUGH WEEK 521
- Data were reported as observed1
- No conclusions of safety or efficacy should be made based on these results
- Number of patients in each study arm are displayed below the graph for each study visit
BSA=body surface area.
EFFICACY AS A MONOTHERAPY MEASURED BY KEY AD ENDPOINTS1
1249 adult and adolescent patients were included in 2 identically designed double-blind, randomized, vehicle-controlled trials.1
In both studies, patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks.1
Key inclusion criteria1,2:
- Affected BSA of 3%-20%
- ≥12 years of age
- IGA score of 2 or 3*
- Diagnosis of AD ≥2 years
Studied in Adults and Adolescents with a Range of MILD TO MODERATE AD Symptoms1
In the clinical trials, which included patients ≥12 years of age1:
Affected BSA
was 3% to 20% (mean ~10%)1
Affected BSA
was
3% to 20% (mean ~10%)1
39%
of patients had facial involvement at baseline1
*Severity scale of 0 to 4.
†Itch NRS=7-day average of the worst level of itch intensity in the last 24 hours, measured on a scale of 0 to 10. Patients in the analysis had an NRS score ≥4 at baseline.1,2
AD=atopic dermatitis; BSA=body surface area; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; IGA-TS=Investigator’s Global Assessment Treatment Success; NRS=numeric rating scale; y=years.
References: 1. Opzelura. Prescribing Information. Incyte Corporation; 2021. 2. Papp K, Szepietowski JC, Kircik L, et al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021;85(4):863-872. doi:10.1016/j.jaad.2021.04.085.
