Patient Profile 1 | Cibinqo®▼ (abrocitinib)

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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)

PATIENT PROFILE 1

Unemployed male with moderate-to-severe atopic dermatitis and increasingly uncontrolled itching leading to sleep deprivation, weight gain and low self-esteem

Who is the patient?

Cibinqo is indicated for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy¹

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.

Caucasian male, 28 years old
Disease and treatment history: Worsening AD for 5–6 years, despite topical corticosteroids, TCI and phototherapy; occasional, mild keratitis, despite no longer wearing contact lenses.
Clinical assessment: EASI=26; 45% BSA (including the head and neck); persistent itching resulting in sleep deprivation; BMI 32
Personal impact: Daily life adversely affected: reluctant to leave the house, weight gain due to poor diet and little exercise, low self-esteem, ability to find employment negatively impacted.
Preferences: Wants to focus on itch and skin clearance

Why consider Cibinqo (abrocitinib)?

1. Cibinqo used in combination with topical therapy provides skin clearance (IGA 0/1 and EASI-75) at Week 12 in significantly more patients compared with placebo^1,2

JADE COMPARE (CO-PRIMARY ENDPOINTS: IGA 0/1 WITH 2-POINT IMPROVEMENT
FROM BASELINE AT WEEK 12, EASI-75 AT WEEK 12)^1,2

In 12 weeks, 48.4% of patients treated with Cibinqo 200 mg achieved IGA 0/1 vs 14.0% with placebo (P<0.001).^1,2
In 12 weeks, 70.3% of patients treated with Cibinqo 200 mg achieved EASI-75 vs 27.1% with placebo (P<0.001).^1,2

Proportion of patients achieving IGA 0/1 (in combination with medicated topical therapy)²

Scroll left to view table

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

Proportion of patients achieving EASI-75 (in combination with medicated topical therapy)^1,2

Example

Scroll left to view table

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

2. Rapid itch relief with Cibinqo 200 mg vs dupilumab at Week 2^1,2

Cibinqo 200 mg was superior to dupilumab at Week 2 in the proportion of patients achieving PP-NRS4* (key secondary endpoint), with significantly higher itch response seen as early as Day 4 after the first dose^1,2

JADE COMPARE (KEY SECONDARY ENDPOINT: PP-NRS4 AT WEEK 2)

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

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 the key secondary head-to-head endpoint, PP-NRS4 at Week 2. This endpoint was further analysed as prespecified multiplicity-controlled analysis and showed superiority to dupilumab down to Day 4.

3. Patients reported improvement in sleep disruption, as measured by SCORAD sleep loss subscale vs placebo at Week 12³

JADE COMPARE (SECONDARY ENDPOINT: CHANGE IN SCORAD (VAS) SLEEP
LOSS SUBSCALE AT WEEK 12)

SCORAD sleep loss subscale at Week 12 (in combination with medicated topical therapy)^1,2

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 guidance².

SCORAD sleep loss subscale is a component of the SCORAD questionnaire.

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.²

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Patient 2

Middle-aged mother with moderate-to-severe atopic dermatitis and uncontrolled, severe eczematous lesions, resulting in selfconsciousness and anxiety.

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Patient 3

Young professional female with moderate-to-severe atopic dermatitis and persistent, uncontrolled itching and lesions that are impacting her work.

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AD=atopic dermatitis; BMI=body mass index; 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; SCORAD=SCORing Atopic Dermatitis; TCI=topical calcineurin inhibitor.

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

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.

Bieber T, et al. N Engl J Med 2021;384(12):1101–1112.

Bieber T, et al. N Engl J Med 2021;384(12):1101–1112. Supplementary appendix.

Data on File: REF-CIB1016, Cibinqo (abrocitinib) Jade Compare (Study B7451029) SCORAD sleep loss subscale, compared with placebo at Week 12, nominal p values.

PP-CIB-GBR-0693. March 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.

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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