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Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
JADE COMPARE was a randomised, double-blind, double-dummy, placebo-controlled pivotal phase 3 clinical trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo + TCS in 837 adult patients with moderate-to-severe AD, with a direct head-to-head comparison vs dupilumab for itch relief, as measured by PP-NRS4, at week 2.1
Skin Clearance
Itch Relief
Patient-reported Outcomes
Data limitations
EASI-75 response for CIBINQO vs placebo at week 12 was a prespecified, multiplicity-controlled primary endpoint and at week 16 was a prespecified multiplicity-controlled key secondary 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. This study was not designed to evaluate CIBINQO vs dupilumab with respect to EASI-75 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.
Data limitations
IGA 0/1 response for CIBINQO vs placebo at week 12 was a prespecified, multiplicity-controlled primary endpoint and at week 16 was a prespecified, multiplicity-controlled key secondary 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. This study was not designed to evaluate CIBINQO vs dupilumab with respect to IGA 0/1 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.
A nominal difference was seen as early as week 2 vs placebo2
Data limitations
EASI-90 response was a prespecified secondary endpoint not controlled for multiplicity. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons can be made. The study was not designed to evaluate CIBINQO vs dupilumab with respect to EASI-90 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.
Skin clearance you can see1,2
Results seen by week 2 and sustained through week 16, with CIBINQO + TCS
Images of patients with moderate-to-severe AD from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary.
SEX: Male | CLINICAL TRIAL: JADE COMPARE |
AGE: 21 | IGA AT BASELINE: Severe |
DOSAGE: 200 mg QD | IGA AT WEEK 2: Moderate |
USE OF MEDICATED TOPICALS: Yes | IGA AT WEEK 12: Clear |
IGA AT WEEK 16: Clear |
Coprimary endpoints:
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
Data limitations4,5
PP-NRS4 response for CIBINQO vs dupilumab and vs placebo at week 2 was a prespecified key secondary endpoint controlled for multiplicity. The onset of pruritus relief was assessed through a step-down approach, day by day, from week 2 to earlier time points once statistical significance was demonstrated at week 2, at the 5% level of significance. Any hypotheses made after the last day for which the comparison was significant was not considered statistically significant. P values at day 4 and day 9 are controlled for multiplicity for the family of PP-NRS4 comparisons.
Coprimary endpoints:
Key secondary endpoints:
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
In a post hoc analysis,
POEM is a patient-reported outcome used to evaluate AD severity by measuring frequency of symptoms in AD over a week’s duration, including itch, sleep disturbance, bleeding skin, weeping/oozing skin, cracked skin, flaking skin, and dry/rough skin, from the patient’s perspective.3
At baseline, the mean value for POEM total score was 21.1 for all groups, which represents severe AD symptoms. The graph above represents percentage of patients who achieved clear or almost-clear AD symptoms.1,4
Data limitations
POEM total score 0-2 (clear/almost-clear response) was a post hoc analysis and the P values are nominal. The study was not designed to evaluate CIBINQO vs dupilumab with respect to POEM. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.
In a post hoc analysis,
DLQI is designed to measure the health-related quality of life in patients with dermatologic conditions. An improvement of ≥4-point reduction in DLQI score is considered clinically meaningful.1,6
Data limitations
DLQI improvement ≥4 points was a post hoc analysis and the P values are nominal.
The study was not designed to evaluate CIBINQO vs dupilumab with respect to DLQI. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.
In a post hoc analysis,
SCORAD is a clinical tool used to assess the extent and severity of AD. This tool takes into account body area, AD intensity, and subjective symptoms, such as itch and sleep, for the past 3 nights. SCORAD VAS sleep loss is one domain of the composite SCORAD.1,8
Data limitations
SCORAD VAS sleep loss <2 response was a post hoc analysis and the P values are nominal.
The study was not designed to evaluate CIBINQO vs dupilumab with respect to SCORAD VAS sleep loss subscale. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.
Coprimary 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