JADE TEEN | Cibinqo® (abrocitinib)

This site contains promotional information intended only for healthcare professionals resident in the United Kingdom

Visit Pfizer Medical site

Log Out

Single Link

Dropdown

Label

Link

Linked Dropdown

Label

Link

Mega Menu

Heading

Example of description text sitting alongside header

Label

Link

Label

Link

Label

Link

Linked Mega Menu

Heading

Example of description text sitting alongside header

Label

Link

Label

Link

Label

Link

EN - English

Select a language

Languages

EN - English

FR - Françias

Log Out

Single Link

Dropdown

Label

Link

Linked Dropdown

Label

Link

Mega Menu

Heading

Example of description text sitting alongside header

Label

Link

Label

Link

Label

Link

Linked Mega Menu

Heading

Example of description text sitting alongside header

Label

Link

Label

Link

Label

Link

EN - English

Select a language

Languages

EN - English

FR - Françias

Log Out

Pfizer Medicines

Therapy Areas

Explore Content

Events

Videos

Materials

Featured Articles

Let’s Connect

Supply

Alliance Healthcare

Off-contract claims

Adverse event reporting can be found at the bottom of the page

About

How Cibinqo works

Introducing Cibinqo

Efficacy

Clinical Efficacy

Study Overview

JADE DARE

JADE COMPARE

JADE MONO

JADE REGIMEN

JADE TEEN

JADE EXTEND

Safety

Safety Guidance

Dosing

Starting your patients on Cibinqo

Practical considerations

Value

Support & Resources

Patient Resources

Videos

Materials

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 a 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 a 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

Scroll left to view table

	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

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

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

Scroll left to view table

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

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-1784. February 2025

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

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search

for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Account

Sign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc

This website is brought to you by Pfizer Limited, a company registered in England

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ

VAT registration number GB201048427

PP-UNP-GBR-11245. January 2025

You are now leaving PfizerPro

You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd.

Pfizer accepts no responsibility for the content or services of the linked site.

PP-UNP-GBR-12070. April 2025

You are now leaving PfizerPro

You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd.

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to Pfizer's medicines or business which it has provided or reviewed.

PP-UNP-GBR-12107. April 2025