Safety and efficacy of Cibinqo evaluated in an ongoing long term extension study
A long-term extension study evaluating the safety and efficacy of Cibinqo, with or without medicated topical therapy, in adults and adolescent patients with moderate-to-severe AD.1,2
Patients who completed Week 92 and remained eligible could enroll in an open-label treatment period with variable length.†
*For patients in JADE REGIMEN, patients must have completed the full open-label run-in period of JADE REGIMEN and failed to meet the protocol-defined response criteria at Week 12.
†Patients could continue to receive Cibinqo in the long-term extension trial until availability of commercial Cibinqo or until the study was terminated in their respective country.
- Incidence of TEAE (treatment-emergent adverse events)
- Incidence of SAE (serious adverse events) and AEs leading to discontinuation
- Incidence of clinical abnormalities and change from baseline in clinical laboratory values, ECG measures and vital signs
- Long term efficacy including IGA and EASI responses, PP-NRS4
inclusion/exclusion criteria2
INCLUSION CRITERIA2
• ≥12 years of age
• Body weight ≥40 kg if applicable from qualifying parent study
• Completed the full treatment or full rescue treatment of a qualifying Phase III study, or completed the full open-label run-in of REGIMEN but did not meet response criteria
EXCLUSION CRITERIA2
• Active forms of other inflammatory skin diseases
• Presence of other medical or psychiatric conditions that would make the patient inappropriate for entry into the study
• Pregnant or breastfeeding women
• Women of childbearing potential who are unwilling to use contraception
• Discontinued from treatment (or rescue treatment) early in a qualifying Phase III study
• Ongoing adverse event in qualifying study
POST HOC ANALYSIS – SKIN CLEARANCE & ITCH RELIEF
Maintenance of response up to 48 weeks of cumulative treatment with either dose of Cibinqo with or without medicated topical therapy1
Among patients who achieved response after 12 weeks of treatment and entered JADE EXTEND, the majority of patients maintained their response at Week 48.
Skin clearance and itch relief over 48 weeks1
Included patients who had received Cibinqo in MONO-1, MONO-2, COMPARE and subsequently enrolled in EXTEND, the long-term extension study. If a patient withdrew from the study, then this patient was counted as non-responder after withdrawal.
Data limitations: Not all patients who completed the pivotal studies continued into the long-term extension study. Efficacy improvements seen in this study may be partially due to awareness of receiving active treatment and background medicated topical therapy.
Biases: JADE EXTEND is a parallel treatment assignment study of Cibinqo 200 mg and 100 mg with no placebo control, revealing the certainty of receiving treatment. The lack of placebo control limits the estimate of treatment effect. Due to patients 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.
POST HOC ANALYSIS – SKIN CLEARANCE
Skin clearance with Cibinqo in patients previously treated with dupilumab1,3
Patients who received dupilumab in COMPARE and then enrolled in EXTEND were randomised to either Cibinqo 200 mg or 100 mg, once daily.1,3
Proportion of patients achieving EASI-75 and IGA 0/1, 12 weeks post switch to Cibinqo3
EASI-75, dupilumab non-responders* IGA 0/1 dupilumab non-responders†
*Dupilumab non-responders are those patients who did not achieve EASI-75 response at Week 16 in JADE COMPARE.
†Dupilumab non-responders are those patients who did not achieve IGA 0/1 response at Week 16 in JADE COMPARE.
Data limitations: Not all patients who completed the pivotal studies continued into the long-term extension study. Efficacy improvements seen in this study may be partially due to awareness of receiving active treatment and background medicated topical therapy. Response to Cibinqo 100 mg and 200 mg after previous treatment with dupilumab was assessed as a post-hoc analysis in the subset of patients who received dupilumab in JADE COMPARE and completed the study before entering into JADE EXTEND.
Biases: JADE EXTEND is a parallel treatment assignment study of Cibinqo 200 mg and 100 mg with no placebo control, revealing the certainty of receiving treatment. The lack of placebo control limits the estimate of treatment effect. Due to patients 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.
Safety
3,128 patients were treated with Cibinqo in clinical studies in AD representing 2,089 patient-years of exposure.
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
AD=atopic dermatitis; AE=adverse event; CI=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; LTE=long term extension; PP-NRS=Peak Pruritus Numerical Rating Scale.
Prescribing information:
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. ClinicalTrials.gov. NCT03422822. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03422822. 3. Shi V, et al. Abstract presented at SDDS, 2021.
PP-CIB-GBR-0066. October 2021
