Efficacy
Rapid and superior itch relief at week 21,2
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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.
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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.
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​​​​​​​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
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PP-NRS4 CIBINQO 200 mg or 100 mg versus dupilumab and placebo, with Rx topicals
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  • 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
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PP-NRS4=≥4-Point Reduction in Peak Pruritus Numerical Rating Scale.
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CIBINQO 200 mg was superior to dupilumab for itch relief at week 2, with significance seen as early as day 4
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​​​​​​​JADE MONO-1 & MONO-2 Study Design
Two identically designed phase 3 monotherapy studies that evaluated efficacy and safety of CIBINQO
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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.

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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.
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As early as week 2, CIBINQO alone demonstrated rapid and significant itch relief across both doses with continued response out to week 12
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Similar results were observed in the MONO-1 study.
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As early as week 2, CIBINQO alone demonstrated rapid and significant itch relief across both doses with continued response out to week 12
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​​​​​​​MONO-2 Results:
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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.
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JADE MONO-1 and MONO-2 included adolescent patients. CIBINQO is approved for patients aged ≥18 years.
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PP-NRS=Peak Pruritus Numerical Rating Scale.
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References: 1. CIBINQO™ (abrocitinib) Full Prescribing Information. April 2021. 2. Data on file. Pfizer Inc; New York, NY.

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​​​​​​​Safety
Take a look at the safety profile.
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