Efficacy
Risk of flare1,2
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JADE REGIMEN Study Design​​​​​​​
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A phase 3 trial that assessed maintenance of treatment effective with continuous dose, dose reduction,​​​​​​​ withdrawl, and an option for rescue tratement in flaring patients
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  • A responder-enriched, double-blind, placebo-controlled, randomized, withdrawal trial in which 1233 patients with moderate-to-severe AD were enrolled in an initial 12-week open-label run-in period from which responders* continued onto a randomized, 40-week, double-blind, monotherapy, maintenance treatment period on CIBINQO 100 mg QD or 200 mg QD or placebo, followed by a 4-week untreated follow-up safety period.
  • Subjects who met the protocol definition of flare† during the blinded treatment entered an open-label rescue treatment period during which they received another 12-week course of CIBINQO 200 mg with topical therapy.​​​​​​​
  •  
​​​​​​​Primary endpoints:
  • Protocol-defined flare requiring rescue treatment. Defined as a loss of at least 50% of the EASI response at week 12 and IGA score of 2 or higher. Measured for each subject using the "Time to protocol-defined flare requiring rescue treatmenT.
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Key secondary endpoint:
  • Loss of response defined as an IGA ≥2​​​​​​​
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Biases
  • Study 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 randomized withdrawal studies are enriched with responders.
  • The run-in phase was open label; all subjects knew they were taking CIBINQO 200 mg.
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Data limitations
  • Use of a different outcome measure for the protocol-defined flare or for the rescue treatment decision than what was used for the primary endpoint (IGA 0/1 with a ≥2-point reduction and an EASI-75 vs loss of 50% EASI response and IGA ≥2).
  • Due to withdrawal design, there was no placebo-control group during the run-in phase.
  • JADE REGIMEN included adolescent patients. CIBINQO is approved for patients aged ≥18 years.​​​​​​​
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*Defined as achieving an IGA of clear (0) or almost clear (1) with a reduction from baseline of ≥2 points and reaching EASI-75.†Defined as a loss of at least 50% of the EASI response at week 12 and an IGA of 2 or higher.
AD=atopic dermatitis; QD=once daily.​​​​​​​
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JADE REGIMEN Results
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In patients who achieved EASI-75 and IGA 0/1 response with CIBINQO 200 mg open-label
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At the end of a 1-year‡ study, patients staying on 200 mg or reducing to CIBINQO 100 mg had a significantly higher probability of being flare§ free versus placebo
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JADE REGIMEN: Probability of not flaring§ at the end of 1 year
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§Flare Definition: A flare requiring rescue treatment of CIBINQO 200 mg + topical therapy was
defined by the protocol as a loss of ≥50% of the EASI response at week 12 and an IGA score of ≥2.


Safety profile from JADE REGIMEN was consistent with pivotal trials. No new safety events 
were observed.


‡The randomized maintenance period was conducted over 40 weeks.This study included a 12-week induction
period.

This study included a 12-week induction period.This study included a 12-week induction period.

EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; OL=open-label.
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JADE REGIMEN rescue phase (open-label)
Percentage of patients recapturing response with CIBINQO 200 mg + topicals after flaring§
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Data Limitations
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    •     This portion of the study was an open-label, non-randomized study. All subjects and investigators knew they were taking CIBINQO 200 mg
    •     Subjects in the open-label rescue period received a 12-week course of CIBINQO 200 mg with topical therapy per local standard of care
    •     All EASI-75 timepoints are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings
    •     No conclusions regarding comparison between these treatment arms can be made
    •     Patients received rescue therapy at different times over the 40-week period relative to when they completed the induction study
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JADE REGIMEN: EASI-75 at 12 weeks of rescue treatment with CIBINQO 200 mg, with Rx topicals
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    •    91.8% of those who were switched to placebo and experienced a flare were able to recapture EASI-75¶ response upon treatment with CIBINQO 200 mg and topical therapy for 12 weeks

    •    74.5% of those who were reduced to CIBINQO 100 mg and experienced a flare were able to recapture EASI-75¶ response after rescue treatment with CIBINQO 200 mg and topical therapy for 12 weeks

    •    55.0% of those who were reduced to CIBINQO 100 mg and experienced a flare were able to recapture EASI-75¶ response after rescue treatment with CIBINQO 200 mg and topical therapy for 12 weeks
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Safety profile from JADE REGIMEN was consistent with pivotal trials. No new safety signals were
observed.

JADE REGIMEN included adolescent patients. CIBINQO is approved for patients aged ≥18 year
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¶Recapture was defined as an improvement of EASI-75 relative to EASI score at the start of rescue
treatment.

References: 1. Data on file. Pfizer Inc; New York, NY. 2. CIBINQO™ (abrocitinib) Full Prescribing
Information. April 2021.

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