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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)
*In JADE COMPARE, significantly more patients achieved skin clearance at week 12, as measured by EASI-75 and IGA 0/1, with either dose of CIBINQO (100 mg or 200 mg) + topical therapy vs placebo + topical therapy1. Additionally, in a post hoc analysis of JADE COMPARE, more patients achieved a clinically meaningful improvement in DLQI with CIBINQO 200 mg vs placebo at Week 16.1,2
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Cibinqo 200 mg shows superior EASI-90 skin clearance at Week 4 (primary endpoint) and Week 16 (secondary endpoint) compared to dupilumab in the JADE DARE trial.6
At Week 4, 29% vs 15% achieved EASI-90 (difference: 14.1%; P<0.0001). At Week 16, 54% vs 42% achieved EASI-90 (difference: 12.5%; P=0.0008)6
Patients may start on 200 mg or 100
mg based on patient characteristics.§
During treatment, the dose may be increased or decreased based on patient's response to treatment.3
Both doses of CIBINQO helped
patients maintain their response.
Contraindications include hypersensitivity to the active substance or any of the excipients, active serious systemic infections(including TB), severe hepatic impairment, pregnancy and/or breast- feeding.3
Summary of safety profile:
The most commonly reported adverse reactions occurring in > 2% of patients treated with 200 mg in placebo-controlled studies are nausea(15.1%), headache(7.9%), acne(4.8%), herpes simplex(4.2%), blood creatine phosphokinase increased (3.8%), vomiting(3.5%), dizziness(3.4%) and abdominal pain upper(2.2%). The most frequent serious adverse reactions are infections(0.3%).3
(Please refer to the CIBINQO Summary of Product Characteristics for full product information)
Atopic dermatitis (AD), sometimes referred to as eczema, is a high-burden chronic condition requiring long-term control7-11
Worldwide, the UK is the 2nd highest scoring country for AD prevalence with an age-standardised prevalence of 6,472 sufferers per 100,000 population12
In a study of 88 patients with AD, itch, skin redness, and dry/flaky skin were the most frequently reported symptoms;13
66% of patients report suffering daily itch13
>75% of patients report experiencing these symptoms every 1–3 days13
In a study with 287 adults enrolled…
…79.1% of adults report ≥1 night(s) of sleep disturbance per week due to AD14
While there is no cure for AD, an effective, long-term treatment plan can control symptoms and alleviate the burden of disease15
With periods of remission interspersed with flares, treatment may need to be adapted according to disease state, or be interrupted due to other conditions or medical care8,16,17
A supportive tool designed to help clinical and non-clinical budgetary decision makers in assessing some of the financial impact of various moderate-to-severe AD treatments.
Download our Getting Started with Cibinqo guide for UK healthcare professionals providing initiation and monitoring guidance for treating
patients with moderate to severe atopic dermatitis.
Efficacy information on Cibinqo from our clinical trial data
Important safety considerations including contraindications and adverse reactions
Profiles of fictional patients with different experiences with AD
AD=atopic dermatitis; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; JAK=Janus kinase; PP-NRS=Peak Pruritus Numerical Rating Scale.
References
1. Bieber T, et al. N Engl J Med. 2021;384:1101–1112.
2. Thyssen JP, et al. J Eur Acad Dermatol Venerol. 2022;36(3):434–443.
3. Cibinqo (abrocitinib) Summary of Product Characteristics.
4. Simpson E, et al. Lancet 2020;395:P255–266.
5. Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873.
6. Reich K, et al. Lancet. 2022;400(10348):273–282.
7. Luger T, et al. Clinical and humanistic burden of atopic dermatitis in Europe: analyses of the National Health and Wellness Survey. Dermatol Ther (Heidelb). 22;12(4):949–969.
8. Abuabara K, Margolis DJ, Langan SM. The long-term course of atopic dermatitis. Dermatol Clin. 2017;35(3):291-7.
9. Frazier W, Bhardwaj N. Atopic dermatitis: diagnosis and treatment. Am Fam Physician. 2020;101(10):590-8.
10. Fasseeh AN, et al. Burden of atopic dermatitis in adults and adolescents: a systematic literature review. Dermatol Ther (Heidelb). 2022;12(12):2653-68.
11. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-92
12. GADA, 2022. Global Report on Atopic Dermatitis 2022. Available at: https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf. Accessed on: 3rd December 2025.
13. Wollenberg A, et al. Patient-reported burden in adults with atopic dermatitis: an international qualitative study. Arch Dermatol Res. 2024;316(7):380
14. Li JC, et al. Sleep disturbance and sleep-related impairment in adults with atopic dermatitis: a cross-sectional study. Dermatitis. 2018;29(5):270-277.
15. Augustin M, Misery L, von Kobyletzki L, Armario-Hita JC, Mealing S, Redding M. Unveiling the true costs and societal impacts of moderate-tosevere atopic dermatitis in Europe. J Eur Acad Dermatol Venereol. 2022;36 Suppl 7:3-16.
16. Blauvelt A, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN Phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-12.
17. Jang YH, et al. Long-term use of oral corticosteroids and safety outcomes for patients With atopic dermatitis. JAMA Netw Open. 2024;7(7):e2423563.
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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PP-UNP-GBR-13971. December 2025