JADE REGIMEN
Evaluating the durability of Cibinqo response with dose maintenance, reduction or withdrawal, and the potential to recapture efficacy1,2
A responder-enriched trial in which 1,233 patients with moderate-to-severe AD were enrolled in an initial 12-week open-label run-in period from which responders (defined as achieving an IGA of clear (0) or almost clear (1) with a reduction from baseline of ≥2 points and reaching an EASI-75 from baseline) continued onto a randomised, 40-week, double-blind, monotherapy, maintenance treatment period on Cibinqo 200 mg, 100 mg or placebo, followed by a 4-weeks untreated follow-up safety period. Patients who met the protocol definition of flare during the blinded treatment entered an open-label rescue treatment period during which they received another 12-week course of Cibinqo 200 mg with topical therapy and the ability to recapture response was assessed.2
STUDY DESIGN2
*Eligible patients had the option to enter JADE EXTEND, a long-term extension study, after completing the initial 12-week treatment, the 12-week rescue treatment, and the 40-week maintenance treatment.
Primary endpoint:
- Protocol-defined flare requiring rescue treatment
Key secondary endpoint:
- Loss of response defined as an IGA ≥2
Biases:
- Study patients may exhibit greater aggregate efficacy responses in this type of trial design than the same measures from phase III, double-blind, placebo-controlled trials because randomised withdrawal studies are enriched with responders
- The run-in phase was open label; all subjects knew they were taking Cibinqo 200 mg
*Other includes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, and not reported.
†Topical agents include corticosteroids, calcineurin inhibitors, and crisaborole.
‡Systemic agents included corticosteroids, cyclosporin, nonbiologic agents, and biologic agents.
Baseline characterstics2
Inclusion/exclusion criteria2
INCLUSION CRITERIA2
- ≥12 years of age
- Body weight ≥40 kg
- Clinically diagnosed with chronic AD for ≥1 year, confirmed by Hanifin and Rajka criteria of AD at the screening and baseline visits
- Have a documented history of inadequate response to treatment with topical medications or require systemic therapies to control their disease
- Moderate-to-severe AD defined as BSA ≥10%, IGA ≥3, EASI ≥16 and PP-NRS ≥4 at the baseline visit
EXCLUSION CRITERIA2
- Active forms of other inflammatory skin diseases or conditions affecting skin
- Prior treatment with any JAK inhibitors
- Unwillingness to discontinue current AD medications prior to the study
- Requiring treatment with prohibited medications during the study
- Medical history of thrombocytopenia, coagulopathy, platelet dysfunction, or Q wave interval abnormalities
- Presence or history of certain infections, cancer, lymphoproliferative disorders, and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women
- Women of childbearing potential who are unwilling to use contraception
PRIMARY ENDPOINT – FLARE REDUCTION
Help your patients reduce flares* with Cibinqo1,2
Whether continuing on Cibinqo 200 mg or decreasing dose to Cibinqo 100 mg, patients had a significantly higher probability of preventing flares up to Week 52 with Cibinqo vs placebo.1,2
Cumulative probability of patients experiencing a flare (200 mg OL → 200 mg)1,2
Cumulative probability of patients experiencing a flare (200 mg OL → 100 mg)2
KEY SECONDARY ENDPOINT – LOSS OF IGA RESPONSE
Help your patients maintain skin clearance with Cibinqo2
Whether continuing on Cibinqo 200 mg or decreasing dose to Cibinqo 100 mg, patients had a significantly higher probability of maintaining IGA 0/1 response up to Week 52 with Cibinqo vs placebo.2
Cumulative probability of IGA 0/1 response loss, Cibinqo 200 mg2
Cumulative probability of IGA 0/1 response loss, Cibinqo 100 mg2
SECONDARY ENDPOINT – FLARE REDUCTION
Cibinqo 200 mg combined with medicated topical therapy recaptured response to treatment after a flare2
Recapture of EASI-75 response with 12 weeks of rescue treatment (in combination with medicated topical therapy)2
Data limitations: These are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Patients in the open-label rescue period received a 12-week course of Cibinqo 200 mg with medicated topical therapy per local standard of care.
Recapture of EASI-75 response with 12 weeks of rescue treatment (in combination with medicated topical therapy)2
EXPLORE MORE
Safety
3,128 patients were treated with Cibinqo in clinical studies in AD representing 2,089 patient-years of exposure.1
View safety guidance
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.
Dosing
Learn more about flexible dosing in patients on Cibinqo.
Discover oral once-daily dosing
*Protocol-defined flare definition: A loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
†This study included a 12-week induction period.
AD=atopic dermatitis; BSA=body surface area; CI=confidence interval; CDLQI=Children's Dermatology Life Quality Index; DLQI=Dermatology Life Quality Index; EASI=Eczema Area and Severity Index; HR=hazard ratio; IGA=Investigator’s Global Assessment; JAK=Janus kinase; OL=open label; POEM=Patient-Oriented Eczema Measure; PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis; PtGA=Patient Global Assessment; SCORAD=SCORing Atopic Dermatitis.
Prescribing information:
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 200 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 100 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 50 mg film-coated tablets.
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. Blauvelt A, et al. JAAD 2021; doi.org/10/1016/j.jaad.2021.05.075.
PP-CIB-GBR-0064. October 2021
