Efficacy
Risk of flare1,2
JADE REGIMEN Study Design
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
- 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.
Key secondary endpoint:
- Loss of response defined as an IGA ≥2
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.
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.
*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.
JADE REGIMEN Results
In patients who achieved EASI-75 and IGA 0/1 response with CIBINQO 200 mg open-label
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
JADE REGIMEN: Probability of not flaring§ at the end of 1 year
§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.
JADE REGIMEN rescue phase (open-label)
Percentage of patients recapturing response with CIBINQO 200 mg + topicals after flaring§
Data Limitations
• 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
JADE REGIMEN: EASI-75 at 12 weeks of rescue treatment with CIBINQO 200 mg, with Rx topicals
• 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
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
¶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.
