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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)
For patients aged 12 years and older with moderate-to-severe AD who are candidates for systemic therapy1
CONTROLSignificant skin clearance vs placebo at Week 12,*2–4 with sustained control through Week 48†1. Review clinical trials within 'Efficacy' section. |
SPEEDRapid itch relief with Cibinqo 200 mg superior to dupilumab at Week 2 in the proportion of patients achieving PP-NRS4 (49.1% vs 26.4% abrocitinib 200mg vs dupilumab respectively),2 with higher itch response seen as early as Day 4 after the first dose (secondary endpoint)‡1. Review clinical trials within 'Efficacy' section. |
FLEXIBILITYPatients can benefit from the option to start on 200 mg or 100 mg§. During treatment the dose may be increased or decreased to meet the needs of your patients1. Review 'Dosing' section for further information. |
Learn more about JAK inhibition, the role of the JAK/STAT pathway and how Cibinqo works.
Discover which patients may be suitable for treatment with Cibinqo.
*In JADE MONO-1 and MONO-2 (monotherapy), a significantly higher proportion of patients achieved EASI-75 at Week 12 with Cibinqo 200 mg (62.7%; 61.0%) and Cibinqo 100 mg (39.7%; 44.5%), compared with placebo (11.8%; 10.4% [P<0.0001 for both doses vs placebo]). In COMPARE, when used in combination with medicated topical therapy, EASI-75 response at Week 12 was observed in 70.3% of patients in the Cibinqo 200 mg group, 58.7% in Cibinqo 100 mg, and 27.1% in placebo (P<0.001 for both doses vs placebo).
†Among patients who achieved EASI-75 after 12 weeks of treatment and entered JADE EXTEND, 71% and 69% of patients in the Cibinqo 200 mg and 100 mg groups maintained EASI-75 at Week 48, respectively.
‡In JADE COMPARE, 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 a prespecified multiplicity-controlled analysis and showed superiority to dupilumab down to Day 4. PP-NRS4 response is defined as a 4 or greater reduction in itch score from baseline on a scale of 0 to 10.
§The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics:
A starting dose of 100 mg once daily is recommended for adolescents (12 to 17 years old), and for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy (see section 4.4). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily.
A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered.
For patients 65 years of age and older, the recommended dose is 100 mg once daily.1
The lowest effective dose for maintenance should be considered1
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