DELIVERED SIGNIFICANT IMPROVEMENT IN EASI SCORES
≥75% IMPROVEMENT IN LESION EXTENT AND SEVERITY
(EASI-75*) AT WEEK 81,2
≥75% IMPROVEMENT IN LESION EXTENT AND SEVERITY (EASI-75*) AT WEEK 81,2
Adapted from Papp K et al. doi:10.17632/ffx6nd5zyb.1. Licensed under CC BY 4.0.
>60% of patients
achieved EASI-75 at week 81
>60% of patients
achieved EASI-75 at week 81
Mild defined as EASI score 1.1–7.0.3
In TRuE-AD1 and TRuE-AD2, respectively, 46% and 50% of patients on OPZELURA vs 56% and 44% of patients on vehicle had a baseline EASI score of 1.1–7.0.4
*EASI-75 is defined as the achievement of at least 75% improvement in EASI score from baseline.1
BID=twice daily; EASI=Eczema Area and Severity Index.
See safety results >
References: 1. 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. Published online May 3, 2021. doi:10.1016/j.jaad.2021.04.085. 2. Papp K, Szepietowski JC, Kircik L, et al. Supplementary appendix, efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from two phase 3, randomized, double-blind studies. Mendeley Data. doi:10.17632/ffx6nd5zyb.1. 3. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357. 4. Data on file. Incyte Corporation. 2021.
improvement IN LESION EXTENT AND SEVERITY (EASI) AT WEEK 81
>70% mean improvement
in EASI score from baseline at week 81
>70% mean improvement
in EASI score from baseline at week 81
Mild defined as EASI score 1.1–7.0.3
In TRuE-AD1 and TRuE-AD2, respectively, 46% and 50% of patients on OPZELURA vs 56% and 44% of patients on vehicle had a baseline EASI score of 1.1–7.0.4
BID=twice daily; EASI=Eczema Area and Severity Index.
See safety results >
References: 1. 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. Published online May 3, 2021. doi:10.1016/j.jaad.2021.04.085. 2. Papp K, Szepietowski JC, Kircik L, et al. Supplementary appendix, efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from two phase 3, randomized, double-blind studies. Mendeley Data. doi:10.17632/ffx6nd5zyb.1. 3. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357. 4. Data on file. Incyte Corporation. 2021.
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 or vehicle BID applied 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 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 10.1,2
AD=atopic dermatitis; BID=twice daily; 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.
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. Published online May 3, 2021. doi:10.1016/j.jaad.2021.04.085.