Patient Profile 3 | 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 3

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

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 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.

British-Jamaican female, 23 years old

Disease and treatment history: AD since early childhood. Has tried several treatments, all with unsatisfactory results, including topical corticosteroids, TCI, phototherapy, ciclosporin and dupilumab 300 mg Q2W (EASI reduction of 50% achieved). Itching and visible lesions remain a persistent problem

Clinical assessment: EASI=27; 40% BSA (including hands, face, flexion points and torso); recent episodes of conjunctivitis

Personal impact: Constant itching causes distraction and sleep deprivation, which both impact her work (personal assistant at a law firm); concerned about losing her job

Preferences: Would like to focus on itch and skin clearance

Why consider Cibinqo (abrocitinib)?

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

JADE COMPARE (CO-PRIMARY ENDPOINTS: EASI-75 at Week 12 and IGA 0/1 with 2-point improvement from baseline at Week 12)²

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

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)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 dupilumab²

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)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 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

3.Higher proportion of patients achieved skin clearance (EASI-90) with Cibinqo vs placebo at Week 12 in combination with medicated topical therapy^1,3

JADE COMPARE (SECONDARY ENDPOINT: EASI-90 at Week 12)^2,3

Proportion of patients achieving EASI-90 (in combination with medicated topical therapy)^1,3,4

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

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.

4. Patients reported improvement in sleep disruption, as measured by SCORAD sleep loss subscale vs placebo at Week 12^2,3

JADE COMPARE (SECONDARY ENDPOINT: Change in SCORAD (VAS) sleep loss subscale at Week 12)^2,3

SCORAD sleep loss subscale at Week 12 (in combination with medicated topical therapy)^3,5

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.

Explore more

Patient 4

Teenage competitive swimmer suffering with moderate-to-severe atopic dermatitis and regular disease flares and itching.

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Patient 1

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

View profile

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 (abrocitinib) Summary of Product Characteristics.

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

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

Data on File: REF-CIB1013, Cibinqo (abrocitinib) Jade Compare (Study B7451029) Proportion of Patients Achieving EASI Response ≥90% improvement from baseline at week 12, nominal p values.

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

PP-CIB-GBR-0695. 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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