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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)
A Cibinqo 200 mg OD responder-enriched trial in which 1,233 patients with moderate-to-severe atopic dermatitis were enrolled in an initial 12-week open-label run-in period from which responders (defined as achieving an IGA of clear (0) or almost clear (1) with a reduction from baseline of ≥2 points and reaching an EASI-75 from baseline) continued onto a randomised, 40-week, double-blind, monotherapy, maintenance treatment period on Cibinqo 200 mg, 100 mg or placebo, followed by a 4-week untreated follow-up safety period. Patients who met the protocol definition of flare during the blinded treatment entered an open-label rescue treatment period during which they received another 12-week course of Cibinqo 200 mg with medicated topical therapy and the ability to recapture response was assessed.2
Medicated topical therapy includes corticosteroids and other medicated topicals per study protocol, used as per investigator’s usual practice.
*Defined as loss of response associated with a decrease of at least 50% in EASI response at Week 12 and IGA response ≥2.
†Eligible patients had the option to enter JADE EXTEND4, a long-term extension study, after completing the initial 12-week treatment, the 12-week rescue treatment, and the 40-week maintenance treatment.
- Loss of response (flare) requiring rescue medication during the maintenance period2
- Loss of response defined as IGA ≥2 during the maintenance period2
- Study patients may exhibit greater aggregate efficacy responses in this type of trial design than the same measures from Phase III, double-blind, placebo-controlled trials because randomised withdrawal studies are enriched with responders2
- The induction period was open label; all subjects knew they were taking Cibinqo 200 mg2
Adapted from Blauvelt A, et al. JAAD 2022;86(1):104-112.
*Other includes American Indian or Alaskan Native, Native Hawaiian or Other Pacific Islander, multiracial, and not reported.
†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
‡Systemic agents included corticosteroids, cyclosporin, nonbiologic agents, and biologic agents.
- ≥12 years of age
- Body weight ≥40 kg
- Clinically diagnosed with chronic AD for ≥1 year, confirmed by Hanifin and Rajka criteria of AD baseline visits (moderate-to-severe AD defined as BSA ≥10%, IGA ≥3, EASI ≥16, and PP-NRS ≥4 at the baseline visit)
- Have a documented history of inadequate response to treatment with topical medications or require systemic therapies to control their disease within six months or less before screening
- Active forms of other inflammatory skin diseases or condition affecting skin
- Prior treatment with any systemic JAK inhibitors
- Unwillingness to discontinue current AD medications prior to the study
- Requiring treatment with prohibited medications during the study
- Medical history of thrombocytopenia, coagulopathy or platelet dysfunction, or Q wave interval abnormalities
- Presence or history of certain infections, cancers, lymphoproliferative disorders, and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women
- Women of childbearing potential who are unwilling to use contraception
Cumulative probability of patients experiencing a flare (200 mg OL → 100 mg DB)1,2
†This study included a 12-week induction period
LOSS OF RESPONSE2
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.
Recapture was defined as an improvement of EASI-75 relative to EASI score at the start of rescue therapy.
Explore more
Access safety information for abrocitinib.
Learn more about flexible dosing in patients on Cibinqo.
AD=atopic dermatitis; BSA=body surface area; CI=confidence interval; OD= once daily; CDLQI=Children's Dermatology Life Quality Index; DLQI=Dermatology Life Quality Index; EASI=Eczema Area and Severity Index; HR=hazard ratio; IGA=Investigator’s Global Assessment; JAK=Janus kinase; OL=open label; DB= double blinded; POEM=Patient-Oriented Eczema Measure; Rx= prescription; PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis; PtGA=Patient Global Assessment; SCORAD=SCORing Atopic Dermatitis.
Cibinqo (abrocitinib) Prescribing Information
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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