SIGNIFICANT ITCH REDUCTION WITH OPZELURA1,2
≥4-POINT IMPROVEMENT IN ITCH (ITCH NRS4*) AT WEEK 81-3
>50% of patients
achieved a clinically meaningful improvement in itch at week 81,2*
- Itch NRS4 response seen as early as day 3
(18.4% vs 4.2% and 13.2% vs 0% vehicle†)4
*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.1,2
†In TRuE-AD1 and TRuE-AD2 respectively.1,2
BID=twice daily; EASI=Eczema Area and Severity Index; NRS=numeric rating scale.
CHANGE IN ITCH NRS THROUGH WEEK 82
Adapted with permission from Papp K et al. J Am Acad Dermatol. doi:10.1016/j.jaad.2021.04.085.
ADDITIONAL EXPLORATORY
ANALYSIS
ADDITIONALEXPLORATORY ANALYSIS
Patient-reported change in Itch NRS score observed as early as day 1 and through day 562
Patient- reported change in Itch NRS score observed as early as day 1 and through day 562
Results were not adjusted for multiple comparisons.
BID=twice daily; EASI=Eczema Area and Severity Index; NRS=numeric rating scale.
See EASI results >
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. 3. 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. 4. Data on file. Incyte Corporation. 2021.
≥4-POINT IMPROVEMENT IN ITCH (ITCH NRS4*) AT WEEK 81-3
Adapted from Papp K et al. doi:10.17632/ffx6nd5zyb.1. Licensed under CC BY 4.0.
*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.1,2
†In TRuE-AD1 and TRuE-AD2, respectively, 37% and 34% more patients treated with OPZELURA achieved Itch NRS4 vs vehicle at week 8.2
BID=twice daily; EASI=Eczema Area and Severity Index; NRS=numeric rating scale.
CHANGE IN ITCH NRS THROUGH WEEK 82
Results were not adjusted for multiple comparisons.
Adapted with permission from Papp K et al. J Am Acad Dermatol. doi:10.1016/j.jaad.2021.04.085.
BID=twice daily; EASI=Eczema Area and Severity Index; NRS=numeric rating scale.
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.
