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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)
Cibinqo is indicated for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy.1
This patient profile is fictional and has been produced for the purposes of medical education. Any actual or potential likeness to real individuals is unintentional.
Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.2
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.2
Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.2
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab2
Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.2
*PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.
Cibinqo 200 mg was compared with dupilumab in a key secondary head-to-head endpoint at Week 2. This endpoint was further analysed as prespecified multiplicity-controlled analysis and showed superiority to dupilumab down to Day 4.2
Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.2
EASI-90 is defined as a 90% improvement in EASI score from baseline.
Data limitations2
EASI-90 at all scheduled points are prespecified secondary endpoints not controlled for multiplicity; treatment differences could represent chance findings.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.
SCORAD sleep loss subscale is a component of the SCORAD questionnaire.
Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.2
Data limitations2
Change from baseline in SCORAD sleep loss is a prespecified secondary endpoint not controlled for multiplicity, therefore treatment differences could represent chance findings.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.
Teenage competitive swimmer suffering with moderate-to-severe atopic dermatitis and regular disease flares and itching.
Unemployed male with moderate-to-severe atopic dermatitis and increasingly uncontrolled itching leading to sleep deprivation, weight gain and low self-esteem.
AD=atopic dermatitis; BSA=body surface area; CI=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; LSM=least squares mean; PP-NRS=Peak Pruritus Numerical Rating Scale; Q2W=once every 2 weeks; SCORAD=SCORing Atopic Dermatitis; TCI=topical calcineurin inhibitor.
Prescribing information:
Cibinqo (abrocitinib) Prescribing Information (Great Britain)
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 www.mhra.gov.uk/yellowcard 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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PP-PFE-GBR-3863. November 2021