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About About How Cibinqo works Introducing Cibinqo Efficacy Efficacy Clinical Efficacy Study Overview JADE DARE JADE COMPARE JADE MONO JADE REGIMEN JADE TEENJADE EXTENDJADE DARE-EXTEND Post Hoc Analysis Safety
Safety
 
Safety
 
Safety Guidance Safety Contextualisation Digital Guide Dosing Dosing Dosing Starting your patients on Cibinqo Practical considerations Value Support & Resources Support & Resources Patient Resources Videos
Materials

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)


Read the JADE DARE and JADE EXTEND studies here:

JADE DARE >>LoadingJADE EXTEND >>LoadingStudy AnalysisJADE DARE-EXTEND post hoc analysis1,7Ongoing LTE study investigating the safety and efficacy of CIBINQO in patients who had previously received dupilumab in JADE DARE.1,6Analysis overview
  • Patients aged ≥18 years with AD for ≥6 months
  • Moderate-to-severe AD (IGA ≥3; EASI ≥16; %BSA ≥10; PP-NRS ≥4)
  • History of inadequate response to topical therapy or requiring systemic therapy
 Adapted from Silverbery JI, et al. 2025 and Reich K, et al. 2022.1,7 

JADE DARE evaluated the efficacy and safety of CIBINQO vs dupilumab (both in combination with medicated topical therapy) in 727 patients with moderate-to-severe AD.7

Assessments during first 12 weeks of JADE EXTEND: IGA, EASI, PP-NRS and DLQI; data were reported as observed; no imputation was made for missing data. Efficacy analyses were descriptive in nature with no formal hypothesis testing but with 95% CIs reported.1

*Patients randomised to dupilumab received a loading dose of 600 mg.7 †Topical therapy includes low- to medium-potency topical corticosteroids and other medicated topicals, which were required per study protocol.7 ‡±Topical therapy includes topical corticosteroids and other medicated topicals, which were used as needed per usual practice.1

JADE DARE-EXTEND POST HOC ANALYSISMost patients achieved or maintained response after switching to CIBINQO 200 mg from dupilumab treatment in JADE DARE1

Outcomes at Week 12 after CIBINQO 200 mg initiation in patients who had received dupilumab for 26 weeks in JADE DARE.1

Example

Adapted from Silverberg JI, et al. 2025 and Pfizer Ltd. Data on File.1–5


Adapted from Silverberg JI, et al. 2025 and Pfizer Ltd. Data on File.1–5

Data limitations: short-term (12 weeks) post hoc analysis with limited patient population. CIs were based on normal approximation and P values were not calculated1

*Responder and non-responder for each outcome was defined as achievement or non-achievement, respectively, of ≥50%, ≥75% or ≥90% improvement from JADE DARE baseline in EASI, ≥4-point improvement in PP-NRS and a score of PP-NRS 0/1 at Week 26 of JADE DARE.1 †In JADE DARE, patients were required to apply topical therapy, while in JADE EXTEND this was optional. JADE EXTEND is a parallel treatment assignment study of CIBINQO 200 mg and CIBINQO 100 mg with no placebo control, revealing the certainty of receiving treatment.1



AD, atopic dermatitis; BSA body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; LTE, long-term extension; n, number of patients in treatment arm; OD, once daily; PPNRS, Peak Puritus Numerical Rating Scale; Q2W, every 2 weeks; SC, subcutaneous; CI, confidence interval; EASI-50/75/90, ≥50%/≥75%/≥90% improvement from baseline in Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; PP-NRS, Peak Pruritus Numerical Rating Scale; PP-NRS4, ≥4-point improvement in PP-NRS.

Explore more Safety

Read the safety information about abrocitinib

View safety guidanceLoading Dosing

Learn more about flexible dosing in patients on Cibinqo

Discover oral once-daily dosingLoading
Explore the JADE clinical trial programme
Prescribing information:
Cibinqo (abrocitinib) Prescribing Information.


References 

1. Silverberg JI, et al. Dermatol Ther (Heidlb). 2025;15(2):367–380. 
2. Pfizer Ltd. Data on File: REF-CIB4002, Cibinqo (abrocitinib) JADE DARE-EXTEND (NCT03422822). Week 12 Dupilumab responder patient outcomes (EASI-50, EASI-75, EASI-90). 
3. Pfizer Ltd. Data on File: REF-CIB3997, Cibinqo (abrocitinib) JADE DARE-EXTEND (NCT03422822). Week 12 Dupilumab responder patient outcomes (PP-NRS0/1, PP-NRS4). 
4. Pfizer Ltd. Data on File: REF-CIB4004, Cibinqo (abrocitinib) JADE DARE-EXTEND (NCT03422822). Week 12 Dupilumab non-responder patient outcomes (EASI-50, EASI-75, EASI-90). 
5. Pfizer Ltd. Data on File: REF-CIB4005, Cibinqo (abrocitinib) JADE DARE-EXTEND (NCT03422822). Week 12 Dupilumab non-responder patient outcomes (PP-NRS0/1, PP-NRS4).
6. ClinicalTrials.gov. NCT03422822. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03422822. Accessed May 2025. 
7. Reich K, et al. Lancet. 2022;400(10348):273–282.

PP-CIB-GBR-1901. July 2025

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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