CIBINQO® (abrocitinib) | Efficacy with Medicated Topicals

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About CIBINQO

Efficacy

Overview

Efficacy of CIBINQO vs dupilumab

Efficacy of CIBINQO + Medicated Topicals

Efficacy of CIBINQO Without Medicated Topicals

Efficacy in Teens (12-<18)

Reduction in Risk of Flares

Long-term Efficacy Results

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Efficacy of CIBINQO vs dupilumab

JADE DARE was a randomised, double-blind, double-dummy, active-controlled, head-to-head phase 3b trial that compared the efficacy and safety of CIBINQO 200 mg + TCS vs dupilumab + TCS in 727 adult patients with moderate-to-severe AD.^1,2

Itch Relief

Skin Clearance

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Fast and superior itch relief in one day after the first dose with CIBINQO 200 mg + TCS vs dupilumab + TCS¹

Additional information¹
PP-NRS4 response for CIBINQO vs dupilumab at week 2 was a primary endpoint controlled for multiplicity. The onset of pruritus relief was assessed through a step-down approach, day by day, from week 2 to earlier time points once statistical significance was demonstrated at week 2, at the 5% level of significance. P value at Day 2 is controlled for multiplicity for the family of PP-NRS4 comparisons.

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.
TCS=topical corticosteroids; AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day; Q2W=every 2 weeks.

In a post hoc analysis,
CIBINQO 200 mg + TCS showed complete or almost complete itch relief as early as week 2²

Data limitations²
PP-NRS 0/1 response was a post hoc analysis and the P values are nominal. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons can
be made.

PP-NRS 0/1 is defined as complete or almost complete itch relief as measured by the PP-NRS scale.
TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.¹
Analyzed in the full analysis set (all randomly assigned patients who received ≥1 dose of study medication). If a patient withdrew from the study or used rescue therapy, then this patient was counted as a nonresponder after that point.

CIBINQO 200 mg + TCS demonstrated rapid and superior improvement vs dupilumab + TCS in a head-to-head study¹

JADE DARE Study Design

TCS includes low- to medium-potency topical corticosteroids arid other medical lopicals.

Primary endpoints:

PP-NRS4 response at week 2 vs dupilumab
EASl-90 response at week 4 vs dupilumab

Key secondary endpoint:

EASl-90 response at week 16 vs dupilumab

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.

Patients randomised to dupilumab received a loading dose of 600 mg.

At week 26, eligible subjects had the option to enter JADE EXTEND; all other subjects entered the 4-week
off-treatment follow-up period.³

AD=atopic dermatitis; QD=once a day; Q2W=every 2 weeks; SC=subcutaneous; PP-NRS=Peak Pruritus Numerical Rating Scale; EASl=Eczema Area and Severity Index.

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Skin Clearance With CIBINQO + Medicated Topicals¹

See Results

References:

Reich K, Thyssen JP, Blauvelt A, et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282.

Reich K, Valenzuela F, Hong HC, et al. Onset and depth of response with abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: analysis of the phase 3b JADE DARE clinical trial. Oral presentation 681. Presented at: 3rd Annual Revolutionizing Atopic Dermatitis Virtual Conference: 11-13 December 2021.

ClinicalTrials.gov. Protocol title: A phase 3b randomized, double-blind, double-dummy, active controlled multi-center study assessing the efficacy and safety of abrocitinib compared with dupilumab in adult participants on background topical therapy with moderate to severe atopic dermatitis. ClinicalTrials.gov identifier: NCT04345367. Updated 14 August 2020. Accessed 20 December 2022. https://www.clinicaltrials.gov/ProvidedDocs/67/NCT04345367/Prot_000.pdf

See full trial design >

Superior skin clearance: ~2x as many patients achieved >90% clearer skin with CIBINQO 200 mg + TCS at week 4 vs dupilumab + TCS¹

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.
Analyzed in the full analysis set (all randomly assigned patients who received ≥1 dose of study medication). If a patient withdrew from the study or used rescue therapy, then this patient was counted as a nonresponder after that point.

TCS=topical corticosteroids; AD=atopic dermatitis; EASl=Eczema Area and Severity lndex; QD=once a day; Q2W=every 2 weeks.

In a post hoc analysis,
Completely clear skin was shown as early as week 4 with CIBINQO 200 mg + TCS^2,3

Data limitations^2,3
EASl-100 response was a post hoc analysis and the P values are nominal. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons can be made.

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.¹
Analyzed in the full analysis set (all randomly assigned patients who received ≥1 dose of study medication). If a patient withdrew from the study or used rescue therapy, then this patient was counted as a nonresponder after that point.¹

CIBINQO 200 mg + TCS demonstrated rapid and superior improvement vs dupilumab + TCS in a head-to-head study¹

JADE DARE Study Design

Primary endpoints:

PP-NRS4 response at week 2 vs dupilumab
EASl-90 response at week 4 vs dupilumab

Key secondary endpoint:

EASl-90 response at week 16 vs dupilumab

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.

Patients randomised to dupilumab received a loading dose of 600 mg.

At week 26, eligible subjects had the option to enter JADE EXTEND; all other subjects entered the 4-week
off-treatment follow-up period.⁴

AD=atopic dermatitis; QD=once a day; Q2W=every 2 weeks; SC=subcutaneous; PP-NRS=Peak Pruritus Numerical Rating Scale; EASl=Eczema Area and Severity Index.

Explore more

Have Any Questions About Efficacy?

Request an eRep Call

Quality of Life Improvements With CIBINQO + Medicated Topicals^5-9

See Results

References:

Reich K, Thyssen JP, Blauvelt A, et al. Supplementary appendix to: Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282.

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Thyssen JP, Yosipovitch G, Paul C, et al. Supplementary appendix to: Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis. J Eur Acad Dermatol Venereol. 2022;36(3):434-443.

Bieber T, Simpson EL, Silverberg JI, et al. Supplementary appendix to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.

Basra MKA, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.

McMichael A, Cork M, Teng J, et al. Patient-reported outcomes with abrocitinib treatment in adolescent patients with moderate-to-severe atopic dermatitis: results from the phase 3 JADE TEEN study. Oral presentation. Presented at: American Academy of Allergy, Asthma & Immunology 2021 Virtual Annual Meeting; 26 February-1 March 2021.

Efficacy

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