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Adverse event reporting can be found at the bottom of the page
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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 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)
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
*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
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*
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
Learn more about JADE DARE-EXTEND Post Hoc Analysis
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.
Access safety information for abrocitinib.
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.
References:
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.
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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