This pivotal phase 3 clinical trial evaluated the efficacy and safety of CIBINQO in combination with Rx topical therapy versus placebo in 838 patients with moderate-to-severe AD, with a direct head-to-head comparison with dupilumab for itch relief at week 2.
Coprimary endpoints:
EASI-75 response at week 12 vs placebo
IGA 0/1 response with ≥2-point improvement at week 12 vs placebo
Key secondary endpoints:
PP-NRS4 response of either dose of CIBINQO vs dupilumab and placebo at week 2
IGA 0/1 response with ≥2-point improvement and EASI-75 response at week 16 vs placebo
*Subjects used non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors, or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study.
†After completing the 16-week treatment period, patients were observed for an additional 4 weeks.
‡At week 20, eligible subjects entered the long-term extension study (JADE EXTEND); ineligible subjects entered the 4-week off-treatment follow-up period. AD=atopic dermatitis; BID=twice daily; EASI=Eczema Area and Severity Index; PDE=phosphodiesterase enzymes; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once-daily.
JADE COMPARE efficacy results
Data Limitations
Primary endpoint was at week 12. All other time points are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
In only 12 weeks, significantly more patients treated with CIBINQO achieved at least 75% skin improvement (EASI -75) in lesion extent and severity versus placebo
JADE COMPARE: EASI-75 for CIBINQO 200 mg or 100 mg versus placebo, with Rx topicals
Analyses shown are between CIBINQO and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between CIBINQO and dupilumab.
EASI-75 responders were patients with ≥75% improvement in EASI from baseline. EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment.
Patients achieving EASI-90 skin clearance
Data Limitations
All time points for EASI-90 are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
Results observed at the higher threshold of EASI-90 JADE COMPARE: EASI-90 for CIBINQO 200 mg or 100 mg versus placebo, with Rx topicals
Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between CIBINQO and dupilumab.
EASI-90 responders were patients with ≥90% improvement in EASI from baseline.
In only 12 weeks, patients experienced fast and significant skin clearance across both doses versus placebo
Data Limitations
Primary endpoint was at week 12. All other time points are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
IGA (0/1) for CIBINQO 200 mg or 100 mg versus placebo, with topical therapy
Analyses shown are between CIBINQO and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between CIBINQO and dupilumab.
See monotherapy study results below
In only 12 weeks, CIBINQO met both coprimary endpoints for skin clearance
EASI-75 responders were patients with ≥75% improvement in EASI from baseline.
IGA=Investigator's Global Assessment.
Two identically designed double-blind pivotal phase 3 monotherapy studies evaluated the efficacy and safety of CIBINQO in 778 patients.
Coprimary endpoints:
IGA 0/1 response with ≥2-point improvement at week 12
EASI-75 response at week 12
Key secondary endpoints:
PP-NRS4 response at weeks 2, 4, and 12
PSAAD response at week 12
JADE MONO-1 and MONO-2 included adolescent patients. CIBINQO is approved for patients aged ≥18 years.
*At week 12, eligible subjects entered the long-term extension study (JADE EXTEND).
AD=atopic dermatitis; IGA=Investigator's Global Assessment; EASI=Eczema Area and Severity Index; PP-NRS4=≥4-Point Reduction in Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessed for Atopic Dermatitis.
Primary endpoint was at week 12. All other time points are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
In only 12 weeks, CIBINQO alone across both doses achieved significantly clearer skin versus placebo JADE MONO-2: EASI-75 for CIBINQO 200 mg or 100 mg versus placebo, without Rx topicals*
Similar results were observed in the MONO-1 study.
*Patients were permitted to use non-medicated emollients during the study.
Results seen by week 12, with or without Rx topicals
Images of patients from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary.
Results seen by week 12, with or without Rx topicals
Images of patients from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary.
Results seen by week 12, with or without Rx topicals
Images of patients from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary.
References: 1. CIBINQO™ (abrocitinib) Full Prescribing Information. April 2021. 2. Data on file. Pfizer Inc; New York, NY.
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