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

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About About How Cibinqo works Introducing Cibinqo Efficacy Efficacy Clinical Efficacy Study Overview JADE DARE JADE COMPARE JADE MONO JADE REGIMEN JADE TEENJADE EXTENDJADE DARE-EXTEND Post Hoc Analysis Safety
Safety
 
Safety
 
Safety Guidance Safety Contextualisation Digital Guide
Dosing Dosing Dosing Starting your patients on Cibinqo Practical considerations Value Support & Resources 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 EXTENDSafety and efficacy of Cibinqo evaluated in an ongoing long term extension study1,2

Patients from qualifying Phase 2 or Phase 3 JADE studies could enter this LTE study evaluating the safety and efficacy of CIBINQO ± topical therapy* in patients aged ≥12 years with moderate-to-severe AD.1,2

STUDY DESIGN1,2

*Patients were required to use background medicated topical therapy with low- or medium-potency TCS, TCI, or topical PDE-4 inhibitors, applied once daily to areas with active lesions, and non-medicated topical emollients twice daily to all areas with AD for the duration of the study.
Patients could continue to receive CIBINQO in the LTE trial until availability of commercial CIBINQO or until the study was terminated in their respective country.2

Primary endpoints:2•    Incidence of TEAEs, SAEs and AEs leading to discontinuation
•    Change from baseline in clinical laboratory values, ECG measurements and vital signs
Secondary endpoints:2•    IGA 0/1 and a reduction from baseline of ≥2 points at all scheduled timepoints
•    EASI-50 at all scheduled timepoints 
•    EASI-75 at all scheduled timepoints 
•    EASI-90 at all scheduled timepoints 
•    PP-NRS3 at all scheduled timepoints
•    PP-NRS4 at all scheduled timepoints

JADE EXTEND INTERIM ANALYSIS (CUT-OFF DATE: 05 SEPTEMBER 2022)
 
Secondary endpoints:CIBINQO maintained long-term efficacy (EASI and PP-NRS) at Week 1123,4

Pooled analysis of studies (Phase 2 monotherapy study, JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE TEEN and JADE DARE patients who subsequently enrolled in JADE EXTEND)1,2*



CIBINQO at either dose, with or without topical therapy, was shown to provide long-term efficacy in skin improvement (EASI) and itch relief (PP-NRS) at Week 112.3,4

Analyses of efficacy data based on observed data – only subjects with available data at a given timepoint were only included in the analysis unless stated otherwise.3,4

*All data are reported using as-observed values, with any missing data excluded from the analysis.3,4

Explore moreEfficacy 

Learn more about JADE DARE-EXTEND Post Hoc Analysis

View JADE DARE-EXTEND Post Hoc Analysis
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  • References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.

Safety

Access safety information for abrocitinib.

View Safety guidance Loading

AD=atopic dermatitis; AE=adverse event; EASI=Eczema Area and Severity Index;EASI-75/90/100= ≥75%/≥90%/100% improvement from baseline in EASI; ECG=electrocardiogram; IGA=Investigator’s Global Assessment; LTE=long term extension; N=number of subjects who were evaluable at Week 112 of CIBINQO treatment; n=number of subjects who met
criteria, including subjects who were a responder at Week 12 visit on CIBINQO in parent study; OD= once daily; OLE=open-label extension; PDE-4=phosphodiesterase-4; PP-NRS=Peak Pruritus Numerical Rating Scale; PP-NRS 0/1=PP-NRS score of 0 (no itch) or 1 (very little itch); PP-NRS4= ≥4-point improvement from baseline in PP-NRS; SAE=Serious adverse event; TCI, topical calcineurin inhibitors; TCS=topical corticosteroids; TEAE=Treatment-emergent adverse event.

Prescribing information:
Cibinqo (abrocitinib) Prescribing Information 

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.ClinicalTrials.gov. NCT03422822. Available at: https://www.clinicaltrials.gov/study/NCT03422822 Accessed May 2025.Pfizer Ltd. Data on File: REF-CIB3942, Cibinqo (abrocitinib) JADE EXTEND (B7451015). 112-week long term efficacy (PP-NRS-4, PP-NRS 0/1)_as observed_Data cutoff Sep 2022.Pfizer Ltd. Data on File: REF-CIB3939, Cibinqo (abrocitinib) JADE EXTEND (B7451015). 112-week long term efficacy (EASI 75, EASI 90, EASI 100) _as observed_Data cutoff 5 Sep 2022.
PP-CIB-GBR-1847 July 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 EXTEND

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

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