JADE TEEN | Cibinqo®▼ (abrocitinib)

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How Cibinqo works

Introducing Cibinqo

MOA Overview

Atopic Dermatitis

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Information on how to access Cibinqo®▼ (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page.
Updated Safety Recommendation - Abrocitinib should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older, patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), patients with malignancy risk factors (e.g. current malignancy or history of malignancy). (Cibinqo Summary of Product Characteristics)

JADE TEEN

Evaluating the efficacy and safety of Cibinqo in combination with medicated topical therapy in adolescent patients with moderate-to-severe atopic dermatitis aged 12–17^1,2

This pivotal Phase III clinical trial evaluated the efficacy and safety of Cibinqo in combination with medicated topical therapy versus placebo in 287 adolescent patients age 12–17 years with moderate-to-severe AD. Patients used non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids and other medicated topicals per protocol guidance to treat active lesions during the study²

STUDY DESIGN^1,2

Adapted from Eichenfield L, et al. JAMA Dermatol 2021;157(10):1165-1173.

*Patients not eligible for JADE EXTEND entered the 4-week off-treatment follow-up period.

¥Two patients randomly assigned to receive abrocitinib, 200mg, were not treated and were not included in the analysis sets.²

The recommended starting dose for adolescents (12-17 years old) is 100 mg¹

Co-primary endpoints:

IGA response (0/1 with a ≥2-grade improvement from baseline) at Week 12 vs placebo
EASI-75 response at Week 12 vs placebo

Key secondary endpoints:

PP-NRS4 improvement at Weeks 2, 4 and 12
Change from baseline in PSAAD at Week 12

Baseline characteristics²

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	Placebo (N=96)	100 mg (N=95)	200 mg (N=94)	All (N=285)

		Cibinqo
Age, median (IQR), y	14.0 (13.5–16.5)	16.0 (14.0–17.0)	15.0 (13.0–16.0)	15.0 (13.0–17.0)
Age group, y • 12–17* • ≥18^†	• 95 (99.0) • 1 (1.0)	• 95 (100.0) • 0	• 94 (100.0) • 0	• 284 (99.6) • 1 (0.4)
Female	52 (54.2)	50 (52.6)	38 (40.4)	140 (49.1)
Male	44 (45.8)	45 (47.4)	56 (59.6)	145 (50.9)
Race, n (%) • White • Asian • Black or African American • Multiracial • Other^‡• Not reported	• 56 (58.3) • 32 (33.3) • 3 (3.1) • 1 (1.0) • 2 (2.0) • 2 (2.1)	• 52 (54.7) • 31 (32.6) • 9 (9.5) • 0 • 3 (3.2) • 0	• 52 (55.3) • 31 (33.0) • 5 (5.3) • 1 (1.1) • 5 (5.4) • 0	• 160 (56.1) • 94 (33.0) • 17 (6.0) • 2 (0.7) • 10 (3.5) • 2 (0.7)
Ethnicity, n (%) • Not Hispanic or Latino • Hispanic or Latino • Not reported	• 65 (67.7) • 25 (26.0) • 6 (6.3)	• 63 (66.3) • 26 (27.4) • 6 (6.3)	• 69 (73.4) • 25 (26.6) • 0	•197 (69.1) • 76 (26.7) • 12 (4.2)
Disease duration, mean (SD), years	10.5 (4.8)	9.8 (5.4)	9.7 (5.3)	10.0 (5.2)
Prior medication for atopic dermatitis^§ • Any prior medication • Topical agents alone^¶ • Systemic ± topical agents^# • Dupilumab	• 95 (99.0) • 71 (74.0) • 24 (25.0) • 1 (1.0)	• 95 (100.0) • 68 (71.6) • 27 (28.4) • 1 (1.1)	• 92 (97.9) • 70 (74.5) • 22 (23.4) • 1 (1.1)	• 282 (98.9) • 209 (73.3) • 73 (25.6) • 3 (1.1)
IGA score • 3 • 4	• 57 (59.4) • 39 (40.6)	• 57 (60.0) • 38 (40.0)	• 61 (64.9) • 33 (35.1)	• 175 (61.4) • 110 (38.6)
EASI score, mean (SD)	29.2 (12.7)	31.0 (12.8)	29.5 (12.2)	29.9 (12.5)
BSA affected, mean (SD), %	45.8 (22.4)	51.2 (21.7)	48.7 (21.7)	48.6 (22.0)
PP-NRS total score	7.2 (1.7)	7.0 (1.8)	6.8 (2.0)	7.0 (1.8)
PSAAD • No. of patients • Total score, mean (SD)	• 95 • 5.0 (2.4)	• 95 • 4.9 (2.1)	• 93 • 4.8 (2.3)	• 283 • 4.9 (2.3)
SCORAD • No. of patients • Total score, mean (SD)	• 96 • 68.5 (13.4)	• 95 • 67.6 (13.5)	• 93 • 66.2 (13.3)	• 284 • 67.5 (13.4)
SCORAD Sleep Loss VAS • No. of patients • Total score, mean (SD)	• 96 • 5.7 (2.9)	• 95 • 5.3 (2.9)	• 93 • 5.6 (2.9)	• 284 • 5.5 (2.9)
CDLQI • No. of patients • Total score, mean (SD)	• 96 • 14.0 (6.7)	• 95 • 14.3 (6.1)	• 94 • 13.6 (7.0)	• 285 • 14.0 (6.6)
POEM • No. of patients • Total score, mean (SD)	• 95 • 19.8 (5.9)	• 95 • 19.5 (6.4)	• 94 • 19.2 (6.2)	• 284 • 19.5 (6.2)

*One patient in the Cibinqo 200 mg group was age 11 years at the time of consent to participate in the study, which was a protocol deviation.
^†One patient in the placebo group was enrolled at age 18 years, which was a protocol deviation.
^‡Includes patients who identified as American Indian or Alaskan native and native Hawaiian or Pacific Islander.
^§Patients were counted once for each main category (i.e., topical agents or systemic agents) in an exclusive manner.
^¶Patients used non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids and other medicated topicals as per protocol guidance to treat active lesions during the study.
^#Systemic agents included corticosteroids, cyclosporin, nonbiologic agents, and biologic agents.

Inclusion/exclusion criteria²

INCLUSION CRITERIA²

12 to <18 years of age
Clinically diagnosed with chronic AD, confirmed by the Hanifin and Rajka criteria of AD at the screening and baseline visits
Criteria for AD diagnosis include ≥3 of the basic features of pruritus: typical morphology and distribution, including flexural lichenification or linearity in adults and facial and extensor involvement in infants and children; chronic or chronically relapsing dermatitis; and personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis); along with ≥3 of 23 minor features specified in the criteria
Have a documented history of inadequate response to treatment with topical medications that were given for 4 consecutive weeks or longer with 6 months before screening or a candidate for systemic therapies
Moderate to severe AD defined as BSA ≥10%, IGA ≥3, EASI ≥16, and PP-NRS ≥4 at the baseline visit
Body weight ≥25 kg
Documented proof of varicella-zoster virus immunity

EXCLUSION CRITERIA²

Active forms of other inflammatory skin diseases
Prior treatment with any systemic JAK inhibitors
Uncontrolled, clinically significant laboratory abnormality that could affect study interpretation
Any major psychiatric condition
Unwillingness to discontinue current AD medications prior to the study
Requiring treatment with prohibited medications during the study
Medical history of thrombocytopenia, coagulopathy or platelet dysfunction
Presence or history of certain infections, cancers, lymphoproliferative disorders, and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women
Women of childbearing potential who are unwilling to use contraception

PRIMARY ENDPOINT – EASI-75 at Week 12

Significantly more patients achieved skin clearance (EASI-75) with Cibinqo vs placebo^1,2

In 12 weeks, 68.5% of adolescent patients treated with Cibinqo 100 mg achieved EASI-75 vs 41.5% with placebo (P<0.05).^1–3

Proportion of patients achieving EASI-75 (in combination with medicated
topical therapy)^1–3

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Adapted from Eichenfield L, et al. JAMA Dermatol 2021;157(10):1165-1173.

The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily.¹

In 12 weeks, 41.6% of adolescent patients treated with Cibinqo 100 mg achieved IGA 0/1 vs 24.5% with placebo (P<0.05).^1–3

PRIMARY ENDPOINT – IGA 0/1 at Week 12

Proportion of patients achieving IGA 0/1 at 12 weeks (in combination with medicated topical therapy)^1–3

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The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily.¹

KEY SECONDARY ENDPOINT – PP-NRS4 AT WEEKS 2, 4 AND 12

Itch relieved with Cibinqo in adolescents^1,2

After 2 weeks, 27.2% of adolescent patients treated with Cibinqo 100 mg achieved PP-NRS4 vs 12.6% with placebo (P=0.0119).^1,2

Proportion of patients achieving PP-NRS4 (in combination with medicated topical therapy)^1–3

Scroll left to view table

Adapted from Eichenfield L, et al. JAMA Dermatol 2021;157(10):1165-1173.

The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily.¹

Explore more

Safety

Access safety information for abrocitinib

View safety guidance

References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.

Dosing

Learn more about flexible dosing in patients on Cibinqo.

Discover oral once-daily dosing

AD=atopic dermatitis; OD= once daily; BSA=body surface area; CDLQI=Children's Dermatology Life Quality Index; CI=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; IQR=interquartile range; JAK=Janus kinase; NS=not significant; PDE4=Type 4 cyclic nucleotide phosphodiesterase; POEM=Patient-Oriented Eczema Measure; PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis; SCORAD=SCORing Atopic Dermatitis; SD=standard deviation; VAS=Visual Analog Scale.

Prescribing information:
Cibinqo (abrocitinib) Prescribing information (Great Britain)

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.

Eichenfield L, et al. JAMA Dermatol 2021; doi: 10.1001/jamadermatol.2021.2830.

Eichenfield L, et al. JAMA Dermatol 2021; doi:10.1001/jamadermatol.2021.2830. Supplementary appendix 3.

PP-CIB-GBR-1043. July 2023

Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc/product/12874/rmms. Patients treated with Cibinqo should be given the Patient Card.

JADE TEEN

Study design
Efficacy results: Skin clearance (primary endpoint)
Efficacy results: Itch reduction (key secondary endpoint)

Explore the JADE clinical trials

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