SAFETY
JADE EXTEND long-term extension safety study1,2
JADE EXTEND Study Design
A long-term extension safety study of adult and adolescent patients with moderate-to-severe AD that also evaluated the efficacy of CIBINQO
Data limitations
This is a double-blind, parallel-treatment assignment study of CIBINQO 100 mg and 200 mg with no placebo control, revealing the certainty of receiving treatment. The lack of placebo control limits the estimate of treatment effect. Due to subjects having to complete a qualified parent study and remaining eligible to receive CIBINQO, there may be an enrichment in response based on the patient population. Response was measured at the specific timepoint, not throughout. These analyses were descriptive in nature, and no formal statistical hypothesis were tested.
- A 92-week, double-blind treatment period followed by an open-label, variable-duration treatment period to evaluate the safety and efficacy of CIBINQO 100 mg QD or 200 mg QD in subjects aged 12 years and older with moderate-to-severe AD
- Subjects must have completed a qualifying parent study and remained eligible to receive CIBINQO, or have completed the full rescue treatment/open-label run-in period of JADE REGIMEN and failed to meet the protocol-defined response criteria at week 12
- Following completion of a qualifying parent study, subjects rolled over to the same dose or were randomized to either arm of this extension study
Patients were allowed to use topical medications as needed.
Primary (safety) endpoint:
• Long-term safety
Secondary (safety) endpoint:
- EASI-75 at week 48
-
PP-NRS at week 48
-
Post hoc response rates for dupilumab responders and nonresponders at 12 weeks post-switch
JADE EXTEND included adolescent patients. CIBINQO is approved for patients aged ≥18 years.
AD=atopic dermatitis; QD=once daily.
Response rates up to ~1 year
Among week 12 responders, the majority of patients treated with CIBINQO maintained durable skin clearance and itch reduction at 48 weeks
Response rates from an LTE study
Response shown with CIBINQO in a subgroup of patients previously treated with dupilumab from a post hoc analysis from an LTE study
Patients who received dupilumab in JADE COMPARE and then enrolled in JADE EXTEND were randomized to either CIBINQO 200 mg or 100 mg once daily
JADE EXTEND: EASI-75 for CIBINQO 12 weeks post switch from dupilumab
*Dupilumab nonresponders are those patients who did not achieve EASI-75 response at week 16.
†Dupilumab responders are those patients who achieved EASI-75 response at week 16.
EASI=Eczema Area and Severity Index; PP-NRS4=≥4-point reduction in Peak Pruritus Numerical Rating Scale; LTE=long-term extension.
References: 1. CIBINQO™ (abrocitinib) Full Prescribing Information. April 2021. 2. Data on file. Pfizer Inc; New York, NY.
