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Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
JADE MONO-1 and MONO-2 were two identically designed, randomised, double-blind, placebo-controlled pivotal phase 3 clinical trials that evaluated the efficacy and safety of CIBINQO as monotherapy vs placebo in 387 and 391 patients with moderate-to-severe atopic dermatitis (AD).1,2
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.
Skin Clearance
Itch Relief
Data limitations
EASI-75 response at week 12 was a prespecified, multiplicity-controlled primary endpoint. All other time points were prespecified, non–multiplicity-controlled secondary endpoints. Therefore, treatment differences could represent chance findings and no conclusions regarding other comparisons can be made.
Images of patients with moderate-to-severe AD from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary.
SEX: Female | CLINICAL TRIAL: JADE MONO-2 |
AGE: 43 | IGA AT BASELINE: Severe |
DOSAGE: 200 mg QD | IGA AT WEEK 12: Moderate |
USE OF MEDICATED TOPICALS: No |
Study design1,2
• In JADE MONO-1 and MONO-2, a total of 124 adolescents were studied.
Please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
Coprimary endpoints:
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
Data limitations
Only PP-NRS4 responses at weeks 2, 4, and 12 were prespecified key secondary endpoints controlled for multiplicity.
Study design1,2
Coprimary endpoints:
Key secondary endpoints:
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
Discover the efficacy of CIBINQO
▼ 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.
Legal Category: S1A
Further information is available upon request
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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PP-UNP-IRL-0176. January 2023