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About CIBINQOEfficacyEfficacyOverviewEfficacy of CIBINQO + Medicated TopicalsEfficacy of CIBINQO Without Medicated TopicalsReduction in Risk of FlaresLong-term Efficacy ResultsBefore and After PhotosGlossarySafetySafetySafety ProfileSafety ConsiderationsLab AbnormalitiesDosing & MonitoringDosing &
MonitoringDosingLab Monitoring

Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
Long-term Efficacy Results

JADE EXTEND is an ongoing long-term extension trial with a 92-week primary treatment period followed by an open-label, variable duration treatment period to evaluate the safety and efficacy of CIBINQO, with or without TCS, in patients with moderate-to-severe AD who have previously participated in a qualifying parent clinical trial.1

Although this clinical trial included adolescents, please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

See full trial design >

Long-term efficacy

Post-dupilumab response rates

From an interim efficacy analysis of the long-term extension study 

Durable response rates up to ~1 year with both doses of CIBINQO1,2*

Data limitations

Not all patients who completed the pivotal studies continued into the long-term extension study. Efficacy improvements seen in this study may be partially due to awareness of receiving active treatment, background medicated topicals, and/or patients who discontinued not being included in the efficacy analyses (as observed data).

Biases

This is a parallel treatment assignment study of CIBINQO 200 mg QD and CIBINQO 100 mg QD with no placebo control, revealing the certainty of receiving treatment. The lack of placebo control limits the estimate of treatment effect. Due to subjects having to complete a qualifying parent study and remaining eligible to receive CIBINQO, there may be an enrichment in response based on the patient population.

*As observed data

+/- TCS includes any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician’s usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies, or biologics) were prohibited during JADE EXTEND.1,2 
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.
PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.
Visit on CIBINQO was based on windowing considering day 1 as the first day of receiving CIBINQO. 
AD=atopic dermatitis; EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day. JADE EXTEND Study Design 
  • JADE EXTEND is currently ongoing.
  • Qualifying parent studies that transition to the long-term extension trial include: JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE DARE,† JADE TEEN, and JADE REGIMEN1-4§ 
  • Patients studied in JADE EXTEND were allowed to use nonmedicated and medicated topical therapies as needed²

Primary endpoint:5

  • Long-term safety
Secondary endpoint:5
  • EASI-75 at all scheduled time points
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at all scheduled time points
  • PP-NRS4 at all scheduled time points
EASI-75 response is defined as at least 75% improvement in EASI score from baseline. ​​​​​​​PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.+/- TCS includes any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician’s usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies, or biologics) were prohibited during JADE EXTEND.1,2
All subjects enrolling from JADE DARE received CIBINQO 200 mg open-label in JADE EXTEND, including all patients from the dupilumab arm.1Subjects continue to receive CIBINQO in the long-term extension trial until availability of commercial CIBINQO or until the study is terminated in their respective country.6Subjects enrolling from the open-label period of JADE REGIMEN who were nonresponders continued receiving CIBINQO 200 mg open label in JADE EXTEND.5 IGA=Investigator's Global Assessment.Explore moreAbout CIBINQO About CIBINQOLoadingPost-dupilumab Response Rates
  See Results Loading

Prescribing information

Please see the CIBINQO Summary of Product Characteristics for more information.

References:Data on file. Pfizer Inc.; New York, NY.CIBINQO Summary of Product CharacteristicsBlauvelt A, Silverberg JI, Lynde CW, et al. Supplementary appendix to: 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):104-112. Eichenfield LF, Flohr C, Sidbury R, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial. JAMA Dermatol. 2021;157(10):1165-1173.ClinicalTrials.gov identifier: NCT03422822. Study to evaluate efficacy and safety of PF-04965842 with or without topical medications in subjects aged 12 years and older with moderate to severe atopic dermatitis (JADE EXTEND). Updated 22 February 2023. Accessed 2 May 2023. https://www.clinicaltrials.gov/ct2/show/NCT03422822Blauvelt A, Silverberg JI, Lynde CW, 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):104-112.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

See full trial design >

Dupilumab nonresponders  
A post hoc analysis from the long-term extension study 

CIBINQO showed skin clearance and itch relief in patients who did not respond to dupilumab1

Dupilumab responders  
A post hoc analysis from the long-term extension study

CIBINQO showed skin clearance and itch relief in patients who previously responded to dupilumab1

Data limitations

EASI-75, EASI-90, and PP-NRS4 response post-switch from dupilumab were post hoc analyses and a a limited patient population was evaluated. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons can be made. 

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. 

EASI-75 response is defined as at least 75% improvement in EASI score from baseline.1
EASI-90 response is defined as at least 90% improvement in EASI score from baseline.1
PP-NRS4 is defined as an improvement of ≥4 points from baseline in the PP-NRS scale.1
+/- TCS includes topical corticosteroids and other medicated topicals used as needed.1,2EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale.

Safety data from JADE EXTEND in patients who received dupilumab in JADE COMPARE1

  • Serious adverse events were reported in 1.4% (n=1) of patients who received CIBINQO 200 mg and 2.3% (n=3) of patients who received CIBINQO 100 mg 
    •  A groin infection was reported while taking 200 mg 
    •  Vertigo, pancreatitis, and eczema herpeticum were reported while taking 100 mg 
  • 1 patient taking CIBINQO 200 mg and 1 patient taking CIBINQO 100 mg had an adverse event that led to discontinuation in JADE EXTEND

CIBINQO has shown skin improvement and itch relief in patients regardless of prior dupilumab treatment response in a post hoc analysis1

JADE EXTEND analysis overview Analysis overview1-3 Reprinted from J Am Acad Dermatol, S0190-9622(22), Shi VY, et al, Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND), p00608, Copyright 2022, with permission form Elsevier. JADE COMPARE evaluated 4 treatment arms: CIBINQO 200 mg QD, CIBINQO 100 mg QD, placebo, and dupilumab 300 mg Q2W.1Patients randomised to dupilumab received a loading dose of 600 mg.1TCS includes low- to medium-potency topical corticosteroids and other medicated topicals, which were required per study protocol,1+/- TCS includes topical corticosteroids and other medicated topicals, which were used as needed per usual practice.1,3Dupilumab or its matching placebo was administered for 16 weeks, with the final injection planned for week 14 to facilitate washout of dupilumab prior to eligible patients entering the long-term extension study. AD=atopic dermatitis; Q2W=every 2 weeks; SC=subcutaneous; QD=once a day.Explore moreAbout CIBINQO About CIBINQOLoadingLearn more about flexible dosing in patients on CIBINQO Go to Dosing Loading

Prescribing information

Please see the CIBINQO Summary of Product Characteristics for more information.

References:Data on file. Pfizer Inc.; New York, NY.Shi V, Bhutani T, Fonacier L, et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol 2022;87(2):351-358.Bhutani T, Deleuran M, Fonacier L, et al. Effective maintenance of response in atopic dermatitis patients after switching from dupilumab to abrocitinib (JADE EXTEND). Poster presented at: American Academy of Allergy Asthma & Immunology 2020 Annual Scientific Meeting—Virtual Experience; 13-15 November 2020.


▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Efficacy
Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

 See Efficacy OverviewLoading

Legal Category: S1A
Further information is available upon request

PP-CIB-IRL-0087 June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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