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Adverse event reporting can be found at the bottom of the page
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Click here for ▼Cibinqo® (abrocitinib) Prescribing Information
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)
Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. (Cibinqo Summary of Product Characteristics)
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Adapted from Simpson EL, et al. 2024 and CIBINQO Summary of Product Characteristics.1,2
*Based on the range of CIBINQO exposure, 1–1714 days in the consistent-dose cohort and 89–1537 days in the variable cohort.
AEs of special interest were observed in JADE EXTEND with CIBINQO1
Incidence rates for AEs of special interest:
| Total integrated safety analysis (consistent dose)* | |
|---|---|
| CIBINQO 100 mg | CIBINQO 200 mg |
| 1053 patients | 1997 patients |
Adapted from Simpson EL, et al. 2024, Pfizer Ltd. Data on File and CIBINQO Summary of Product Characteristics.1–4
Please refer to CIBINQO warnings and precautions in the Summary of Product Characteristics.
*Consistent-dose cohort included patients who received the same CIBINQO dose during the entire exposure time in the Phase IIb study (NCT02780167) or JADE parent studies (MONO-1, MONO-2, COMPARE, TEEN, DARE and REGIMEN) and / or subsequently enrolled in JADE EXTEND.
Patients who are ≥65 years of age are more likely to develop certain AEs when compared with younger patients (18 to <65 years)1
Incidence rates for AEs of special interest analysed by age group in long-term (up to ~4.5 years) integrated safety analysis in the consistent-dose cohort (n=3050)*
| Total integrated safety analysis (n=3848) | |
|---|---|
| Consistent-dose cohort* | Variable dose cohort† |
| 3050 patients | 798 patients |
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Please refer to CIBINQO warnings and precautions in the Summary of Product Characteristics.
*Consistent-dose cohort included patients who received the same CIBINQO dose during the entire exposure time in the Phase IIb study (NCT02780167) or JADE parent studies (MONO-1, MONO-2, COMPARE, TEEN, DARE and REGIMEN) and / or subsequently enrolled in JADE EXTEND.
| MACE | VTE | SERIOUS INFECTIONS | |
|---|---|---|---|
| Incidence rates expressed/extrapolated as IR per 100 PY (95% CI) | |||
| UK population-based cohort study including patients aged ≥18 years with moderate and severe AD (n=214,216)6,7* | 1.1 (1.1, 1.1) to 1.35 (1.29, 1.4) | ||
| US cohort study including patients aged ≥12 years with moderate-to-severe AD (n=8197)8†‡ | 0.26 (0.21, 0.32) | 0.20 (0.15, 0.25) | |
| Danish cohort study including patients aged ≥15 years with severe AD (n=2527)9§ | 0.63 (0.51, 0.78) | ||
Data limitations: no comparison group without AD or on advanced treatments (such as JAKi) was included, and thus it is not possible to directly compare IRs in people with vs without AD or on advanced treatments (JAKi) vs on systemic treatments only. The databases do not have detailed information on disease severity based on clinical examination using validated scoring lists and tools. The generalisability of the findings is limited by the exclusion criteria that were applied in those cohort studies. The studies were descriptive in nature, causality cannot be inferred.
*IR for serious infection has been converted to IR per 100 PY from IR per 1000 PY reported in the paper (moderate AD 10.96 [95% CI: 10.78, 11.14]; severe AD 13.45 [95% CI: 12.88, 14.04]).6 †IR for MACE has been converted to IR per 100 PY from IR per 1000 PY reported in the paper (2.6 [95% CI: 2.1, 3.2].8 ‡IR for VTE has been converted to IR per 100 PY from IR per 1000 PY reported in the paper (2.0 [95% CI: 1.5, 2.5]).8 §IR for MACE has been converted to IR per 100 PY from IR per 10,000 PY reported in the paper (severe AD 62.74 [95% CI: 50.72, 77.60]).9
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Data limitations: all patients diagnosed with AD in the 2-year tracking period (January 2022–January 2024) were included and assigned to one of two treatment groups – those with newly initiated therapy with an oral JAKi* and those newly initiated on dupilumab.† There remains the possibility that complications with longer latency periods may not have yet developed. Long-term follow-up data are required to validate results from this study. Additional limitations include the reliance on ICD-10 codes for exposures and outcomes, introducing the possibility of misclassification, the possibility of indication bias and residual unmeasured confounding. Furthermore, there is a lack of data on the severity assessment scoring system for AD, not all patients had their body surface area recorded in the registry and a stratified log-rank test or variance estimation was not performed to account for the matched nature of the sample, which may have made the results less likely to reject the null hypothesis.
This is not an exhaustive presentation of the AEs investigated in the study.
Please refer to CIBINQO warnings and precautions in the Summary of Product Characteristics.
*JAKis included abrocitinib, baricitinib and upadacitinib. †Doses not specified. ‡The two treatment groups were propensity-score matched 1:1 based on demographics, comorbidities and prior medications.
Read more about the safety profile of Cibinqo
Log in to download the Safety Contextualisation Guide
Explore patient profiles and efficacy data here
Please refer to CIBINQO warnings and precautions in the Summary of Product Characteristics.
AE, adverse event; CI, confidence interval; IR, incidence rate; JAKi, Janus kinase inhibitor; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; n, number of evaluable patients; PY, patient-year; VTE, venous thromboembolism.
References
1. Simpson EL, et al. Poster presented at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Meeting 2024; 31 May–3 June 2024; Valencia, Spain.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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