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Pivotal Trial Results
Post-Hoc Analysis Results
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Post Hoc Analysis Overview
Post Hoc Analysis Results
Example
JADE EXTEND is a phase 3, long-term extension safety study for eligible subjects receiving CIBINQO who have completed a qualifying JADE parent study. The primary endpoints in JADE EXTEND are the incidence of safety events and clinical abnormalities. Efficacy analyses were descriptive in nature. No patients received placebo in JADE EXTEND.1 See the JADE EXTEND study design.
This post hoc analysis evaluated adults ≥18 years of age who previously received dupilumab in JADE COMPARE and subsequently entered JADE EXTEND. Patients had a history of inadequate response to topical therapies or required systemic therapy.1
Data limitations
Responses were not controlled for multiplicity and were descriptive in nature with no formal hypothesis testing. No conclusions regarding treatment differences should be made.1
Biases
Efficacy improvements seen in this study may be partially due to awareness of receiving active treatment.1
See the JADE COMPARE EASI-75 Data.
This analysis evaluates patients based on their response to dupilumab + TCS in JADE COMPARE, defined as:
Prior response or non-response to dupilumab was not considered in the inclusion criteria for enrollment in JADE EXTEND. Not all patients who completed the pivotal studies continued into the long-term extension study.1,3
JADE EXTEND is a phase 3, long-term extension safety study for eligible subjects receiving CIBINQO who have completed a qualifying JADE parent study. The primary endpoints in JADE EXTEND are the incidence of safety events and clinical abnormalities. Efficacy analyses were descriptive in nature. No patients received placebo in JADE EXTEND.1 See the JADE EXTEND study design.
This post hoc analysis evaluated adults ≥18 years of age who previously received dupilumab in JADE COMPARE and subsequently entered JADE EXTEND. Patients had a history of inadequate response to topical therapies or required systemic therapy.1
Data limitations
Responses were not controlled for multiplicity and were descriptive in nature with no formal hypothesis testing. No conclusions regarding treatment differences should be made.1
Biases
Efficacy improvements seen in this study may be partially due to awareness of receiving active treatment.1
See the JADE COMPARE EASI-75 Data.
RECOMMENDED DOSE: CIBINQO 100 mg
If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
Take a look at the safety information for CIBINQO
See visible improvements in patients
Learn more about identifying patients appropriate for CIBINQO
Learn more about identifying patients appropriate for CIBINQO
Resources such as the discussion guide and patient brochure can help
A product representative is available to help you learn more about CIBINQO
To report an adverse event, please call 1-800-438-1985
Pfizer for Professionals 1-800-505-4426
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