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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)
  

JADE Clinical Trial Programme

CIBINQO was investigated in the JADE clinical trial programme for AD1–4

There were three additional studies in the JADE programme: JADE MONO-1, JADE MONO-2 and JADE TEEN. JADE MONO-1 and MONO-2 were two identical Phase 3, double blind, 12-week studies evaluating CIBINQO 200 mg or 100 mg monotherapy OD vs placebo in patients ≥12 years old.5,6 JADE TEEN was a Phase 3, double-blind, 12-week study evaluating CIBINQO 200 mg + topical therapy or CIBINQO 100 mg + topical therapy OD vs placebo in patients aged 12–17 years.7

JADE DARE Study Design 
Randomised, double-blind, double-dummy, active-controlled, head-to-head Phase 3 trial comparing the efficacy and safety of CIBINQO 200 mg + topical therapy* vs dupilumab + topical therapy* in 727 adult patients with moderate-to-severe AD.

 

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Primary endpoints: PP-NRS4 response at Week 2; EASI-90 response at Week 4
Key secondary endpoint: EASI-90 response at Week 16
Additional analysis: EASI-100 at all scheduled timepoint

*Patients were required to use standardised low- to medium-potency topical medical therapy on active lesions from Day 1 and throughout the study. Patients were also required to apply non-medicated topical emollients at least twice per day to all affected body areas, starting on Day 1 and throughout the remainder of the study. †Patients randomised to dupilumab received a loading dose of 600 mg. ‡Participants with intolerable AD symptoms were eligible to receive rescue therapy after
Week 4, which included high-potency topical therapy for up to 2 weeks at a time or systemic corticosteroids for up to 10 days.
  Read JADE DARE study + outcomes Loading
JADE COMPARE Study Design
Phase 3 trial evaluating the efficacy and safety of CIBINQO + topical therapy* vs placebo + topical therapy*, and vs dupilumab + topical therapy* as an active comparator for itch relief (PP-NRS4) in 838 patients with moderate-to-severe AD.2,8

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*Emollients were used BID, starting ≥7 days before randomisation and continued throughout the trial, and topical medication (applied OD) was started on Day 1 of the treatment period. Topical therapies allowed during the trial included low- or medium potencyTCS, TCI, and topical PDE-4 inhibitors; patients were allowed to use >1 topical agent.2,8
See JADE COMPARE study + outcomes LoadingJADE COMPARE Post hoc Analysis2,10
 Assessments: 
EASI at Weeks 2, 4, 8, 12 and 16 scored by body region; SCORAD at Weeks 2, 4, 8, 12 and 16 scored by body region.
CIBINQO 200mg OD + topical therapy or
CIBINQO 100mg OD + topical therapy vs
placebo + topical therapy vs
dupilumab 300 mg Q2W + topical therapy 
Patients aged ≥18 years with moderate-to-severe AD
N=837

As these results are based on a post hoc analysis, they are not powered to draw meaningful conclusions and should, therefore, be interpreted with caution.10

Statistical comparisons between CIBINQO and dupilumab were not planned for this analysis and direct comparisons between CIBINQO and dupilumab cannot be made based on these findings. Study limitations also include that it only covered a 16-week follow-up, and did not compare the impact of treatment on the scalp, palms, and soles.10

JADE REGIMEN Study design
Responder-enriched trial of 1233 patients with moderate-to-severe AD. After a 12-week open-label run-in, responders* continued onto a double-blind, randomised 40-week maintenance treatment period on monotherapy with CIBINQO 200 mg, 100 mg or placebo (followed by a 4-week untreated follow-up safety period). Patients experiencing a flare during blinding received open-label rescue treatment with CIBINQO 200 mg + topical therapy† for 12 weeks.3

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Biases: patients may exhibit greater aggregate efficacy responses in this type of trial design than the same measures from Phase 3, double-blind, placebo-controlled trials because randomised withdrawal studies are enriched with responders. The induction period was open-label.3

*Open-label induction period responders were defined as achieving an IGA of 0 or 1 with a reduction from baseline of ≥2 points and reaching an EASI-75 from baseline.3 †Topical therapy options included corticosteroids and calcineurin inhibitors, used per investigator’s usual practice.3 ‡Eligible patients had the option to enter JADE EXTEND, a long-term extension study, after completing the initial 12-week treatment, the 12-week rescue treatment, and the 40-week maintenance treatment.3
See JADE REGIMEN study + outcomes LoadingJADE EXTEND Study Design 
Patients from qualifying Phase 2 or Phase 3 JADE studies could enter this LTE study evaluating the safety and efficacy of CIBINQO ± topical therapy* in patients aged ≥12 years with moderate-to-severe AD.4,8
Primary endpoints:4
  • Incidence of TEAEs, SAEs and AEs leading to discontinuation
  • Change from baseline in clinical laboratory values, ECG measurements and vital signs
Secondary endpoints include:4
  • IGA 0/1 and a ≥2 point reduction from baseline
  • EASI-50
  • EASI-75
  • EASI-90
  • PP-NRS3
  • PP-NRS4   

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See JADE EXTEND study + outcomesLoading
Explore morePatient Profiles

Explore patient profiles and effficacy data here

 Cibinqo Patient ProfilesLoading Safety Considerations

Read more about the safety profile of Cibinqo

Safety ConsiderationsLoading Dosing

Learn more about dosing and administration.

 DosingLoading
AD, atopic dermatitis; AE, adverse event; BID, twice daily; BSA, body surface area; CI, confidence interval; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EASI-50/75/90, ≥50%/≥75%/≥90% improvement from baseline in EASI; EASI-75, ≥75% improvement from baseline in EASI; EASI-90/100, ≥90%/100% improvement from baseline in Eczema Area and Severity Index; ECG, electrocardiogram; IGA, Investigator’s Global Assessment; LTE, long-term extension; mITT, modified intention-to-treat (which included all patients who underwent randomisation and received ≥1 dose of trial drug or placebo); N, total study population; n, number of patients in treatment arm; OD, once daily; OLE, open-label extension; PDE, phosphodiesterase; PP-NRS, Peak Pruritus Numerical Rating Scale; PP-NRS3, ≥3-point improvement in baseline from Peak Pruritus Numerical Rating Scale; PP-NRS4, ≥4-point improvement from baseline in Peak Pruritus Numerical Rating Scale; Q2W, every 2 weeks; SAE, serious adverse event; SC, subcutaneous; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids; TEAE, treatment-emergent adverse event.
References:
1. Reich K, et al. Lancet. 2022;400(10348):273–282.
2. Bieber T, et al. N Engl J Med. 2021;384(12):1101–1112.
3. Blauvelt A, et al. JAAD. 2022;86(1):104–112
4. ClinicalTrials.gov. NCT03422822. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03422822. Accessed June 2025.
5. Simpson E, et al. Lancet. 2020;396(10246):255–266.
6. Silverberg J, et al. JAMA Dermatol. 2021;156(8):863–873.
7. Eichenfield LF, et al. JAMA Dermatol. 2021;157(10):1165–1173.
8. CIBINQO Summary of Product Characteristics.
9. Shi V, et al. J Am Acad Dermatol. 2022;87(2):351–358
10. Alexis A, et al. Dermatol Ther (Heidelb). 2022;12:771–785.

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.

PP-CIB-GBR-2046 December 2025

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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