Rapid and superior itch relief at week 21,2
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 Itch Relief Results
CIBINQO 200 mg was superior to dupilumab for itch relief at week 2 with significance seen as early as day 4
PP-NRS4 CIBINQO 200 mg or 100 mg versus dupilumab and placebo, with Rx topicals
CIBINQO 200 mg was compared to dupilumab in a key secondary head-to-head endpoint at week 2. This endpoint was further analyzed as prespecified multiplicity-controlled analysis with sequential gatekeeping procedure and showed superiority to dupilumab down to day 4
CIBINQO 100 mg was also compared to dupilumab in a key secondary head‑to‑head endpoint at week 2 and was numerically higher but showed no statistically significant difference
Week 12 was a prespecified secondary endpoint not controlled for multiplicity
PP-NRS4=≥4-Point Reduction in Peak Pruritus Numerical Rating Scale.
CIBINQO 200 mg was superior to dupilumab for itch relief at week 2, with significance seen as early as day 4
JADE MONO-1 & MONO-2 Study Design
Two identically designed phase 3 monotherapy studies that evaluated efficacy and safety of CIBINQO
Coprimary endpoints:
EASI-75 response at week 12
IGA 0/1 response with ≥2-point improvement at week 12
Key secondary endpoints:
PP-NRS4 response at weeks 2, 4, and 12
PSAAD response at week 12
*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.
JADE MONO-1 and MONO-2 Itch Relief 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.
As early as week 2, CIBINQO alone demonstrated rapid and significant itch relief across both doses with continued response out to week 12
Similar results were observed in the MONO-1 study.
As early as week 2, CIBINQO alone demonstrated rapid and significant itch relief across both doses with continued response out to week 12 MONO-2 Results:
Percentage of patients achieving ≥4-point reduction in PP-NRS
A higher proportion of patients taking CIBINQO 200 mg achieved itch relief in as early as 2 days after the first dose compared to placebo. JADE MONO-1 and MONO-2 included adolescent patients. CIBINQO is approved for patients aged ≥18 years.
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