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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.
Long-term efficacy
Post-dupilumab response rates
From an interim efficacy analysis of the long-term extension study
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.
Primary endpoint:5
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
▼ 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.
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.
Safety data from JADE EXTEND in patients who received dupilumab in JADE COMPARE1
CIBINQO has shown skin improvement and itch relief in patients regardless of prior dupilumab treatment response in a post hoc analysis1
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
▼ 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.
Discover the efficacy of CIBINQO
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PP-UNP-IRL-0176. January 2023