JADE COMPARE | Cibinqo®▼ (abrocitinib)

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How Cibinqo works

Introducing Cibinqo

MOA Overview

Atopic Dermatitis

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Information on how to access Cibinqo®▼ (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page.
Updated Safety Recommendation - Abrocitinib should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older, patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), patients with malignancy risk factors (e.g. current malignancy or history of malignancy). (Cibinqo Summary of Product Characteristics)

JADE COMPARE

Cibinqo efficacy in combination with medicated topical therapy vs placebo and vs dupilumab^1,2

This pivotal Phase III clinical trial evaluated the efficacy and safety of Cibinqo in combination with medicated topical therapy vs placebo in 838 patients with moderate-to-severe atopic dermatitis, with a direct head-to-head comparison with dupilumab as an active comparator for itch relief at Week 2 (secondary endpoint). Patients used non-medicated emollient twice daily, at least 7 days before randomisation and continued throughout the trial. They used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.^1,2

STUDY DESIGN^1,2

Co-primary endpoints²:

EASI-75 response at Week 12 vs placebo (defined as a 75% improvement in EASI score from baseline)
IGA 0/1 response with ≥2-point improvement at Week 12 vs placebo

Key secondary endpoints²:

•   PP-NRS4 response of either dose of Cibinqo vs dupilumab and vs placebo at Week 2
(deﬁned as an improvement of ≥4 points from baseline in the severity of PP-NRS)

•   IGA 0/1 response with ≥2-point improvement at Week 16 vs placebo

•   EASI-75 response at Week 16 vs placebo

The primary analysis of efficacy was performed in the modified intention-to-treat-population, which included all the patients who had undergone randomisation and received at least 1 dose of a trial drug or placebo.

Baseline characteristics^*2

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	Cibinqo 200 mg, OD (N=226)	Cibinqo 100 mg, OD (N=238)	Dupilumab 300 mg, every other week (N=242)	Placebo (N=131)
Age, years	38.8 ±14.5	37.3 ±14.8	37.1 ±14.6	37.1 ±15.2
Female sex, n (%)	122 (54.0)	118 (49.6)	134 (55.4)	54 (41.2)
Race, n (%)^† • White • Black • Asian • Other	• 161 (71.2) • 9 (4.0) • 53 (23.5) • 3 (1.3)	• 182 (76.5) • 6 (2.5) • 48 (20.2) • 2 (0.8)	• 176 (72.7) • 14 (5.8) • 46 (19.0) • 6 (2.5)	• 87 (66.4) • 6 (4.6) • 31 (23.7) • 7 (5.3)
Duration of AD, years	23.4 ±15.6	22.7 ±16.3	22.8 ±14.8	21.4 ±14.4
IGA score, n (%) • 0, clear • 1, almost clear • 2, mild • 3, moderate • 4, severe	• 0 • 0 • 0 • 138 (61.1) • 88 (38.9)	• 0 • 0 • 0 • 153 (64.3) • 85 (35.7)	• 0 • 0 • 0 • 162 (66.9) • 80 (33.1)	• 0 • 0 • 0 • 88 (67.2) • 43 (32.8)
EASI score	32.1 ±13.1	30.3 ±13.5	30.4 ±12.0	31.0 ±12.6
BSA involvement, %	50.8 ±23.0	48.1 ±23.1	46.5 ±22.1	48.9 ±24.9
PP-NRS score	7.6 ±1.5	7.1 ±1.7	7.3 ±1.7	7.1 ±1.8
SCORAD score	69.3 ±12.7	66.8 ±13.8	67.9 ±11.4	67.9 ±12.0
POEM score	21.5 ±5.3	20.9 ±5.3	21.2 ±5.5	20.4 ±6.1
DLQI score	16.3 ±6.6	15.5 ±6.4	15.6 ±6.7	15.2 ±6.9
**Coexisting medical conditions • Asthma • Allergic conjunctivitis • Food allergy	• 82 (36.3) • 18 (8.0) • 39 (17.3)	• 79 (33.2) • 21 (8.8) • 36 (15.1)	• 75 (31.0) • 26 (10.7) • 36 (14.9)	• 48 (36.6) • 14 (10.7) • 14 (10.7)

*Plus-minus values are means ±SD. Percentages may not total 100 due to rounding.
^†Race was reported by the patients.

Inclusion/exclusion criteria^2,3

INCLUSION CRITERIA²

≥18 years of age
Clinically diagnosed with chronic AD for ≥1 year and current status of moderate-to-severe disease, confirmed by Hanfin and Rajka criteria of AD at the screening and baseline visits. Criteria for AD include ≥3 of the basic features of pruritus: typical morphology and distribution, including flexural lichenification or linearity in adults and facial and extensor involvement in infants and children; chronic or chronically relapsing dermatitis; and personal or family history of atopy (asthma, allergic rhinitis, AD); along with ≥3 of 23 minor features specified in the criteria
Have a documented history (within 6 months before the screening visit) 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 CRITERIA^2,3

Active forms of other inflammatory skin diseases
Prior treatment with any systemic JAK inhibitors
Prior treatment with dupilumab and/or a history of hypersensitivity, intolerance, AE, or allergic reaction associated with prior exposure to the excipients of dupilumab
Vaccination with, or exposure to, a live or attenuated vaccine within 6 weeks prior to the first dose
Participation in other clinical studies involving investigational drug(s) within 8 weeks prior to study entry
Uncontrolled, clinically significant laboratory abnormality that could affect study interpretation
Any major psychiatric condition
Unwillingness to discontinue current AD medications prior to the study
Requiring treatment with prohibited medications during the study
Medical history of thrombocytopenia, coagulopathy or platelet dysfunction, or Q wave interval abnormalities
Presence or history of certain infections, cancers, 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 – SKIN CLEARANCE

Significantly more patients achieved skin clearance (EASI-75) with Cibinqo vs placebo^1,2

In 12 weeks, 70.3% of patients treated with Cibinqo 200 mg achieved EASI-75 vs 27.1% with placebo (P<0.001).^1,2

Proportion of patients achieving EASI-75 (in combination with medicated topical therapy)²

Adapted from Bieber T, et al. N Eng J Med 2021;384:1101–1112.

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EASI-75 at Week 12	no./Total no. (%, 95% CI)
Cibinqo 200 mg	154/219 (70.3%; 64.3–76.4)
Cibinqo 100 mg	138/235 (58.7%; 52.4–65.0)
Dupilumab 300 mg	140/241 (58.1%; 51.9–64.3)
Placebo	35/129 (27.1%; 19.5–34.8)

EASI-75 response is defined as a 75% improvement in EASI score from baseline.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab²

Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.² For most patients, particularly those with severe disease, the recommended starting dose is 200 mg. A starting dose of 100 mg once daily is recommended for patients ≥65 years and adolescents (12–17 years old).¹

Significantly more patients achieved skin clearance (IGA 0/1) with Cibinqo vs placebo^1,2

In 12 weeks, 48.4% of patients treated with Cibinqo 200 mg achieved IGA 0/1 vs 14.0% with placebo (P<0.001).^1,2

Proportion of patients achieving IGA 0/1 (in combination with medicated topical therapy)^1,2

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Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.²

IGA response is defined as an IGA score of 0 or 1 and a ≥2-point improvement from baseline.

Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab²

KEY SECONDARY ENDPOINT – ITCH REDUCTION

Rapid itch relief with Cibinqo 200 mg vs dupilumab at Week 2^1,2

Cibinqo 200 mg was superior to dupilumab at Week 2 in the proportion of patients achieving PP-NRS4, with significantly higher itch response* seen as early as Day 4 after the first dose.^1,2

49.1% (111/226) of patients achieved PP-NRS4 with Cibinqo 200 mg at Week 2

Proportion of patients achieving PP-NRS4 (in combination with medicated topical therapy)^1–3

Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.²

*PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS. Cibinqo 200 mg was compared with dupilumab in the key secondary head-to-head endpoint, PP-NRS4 at Week 2. This endpoint was further analysed as prespecified multiplicity-controlled analysis and showed superiority to dupilumab down to
Day 4.^2,3

SECONDARY ENDPOINT – SKIN CLEARANCE

Higher proportion of patients achieved skin clearance (EASI-90) with Cibinqo vs placebo at Week 12 in combination with medicated topical therapy^1,3

Proportion of patients achieving EASI-90 (in combination with medicated topical therapy)^1,3,4

Scroll left to view table

Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.²

EASI-90 is defined as a 90% improvement in EASI score from baseline.

Data limitations: EASI-90 at all scheduled points are prespecified secondary endpoints not controlled for multiplicity; treatment differences could represent chance findings.^2,3

Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.^2,3

SECONDARY ENDPOINT – PATIENT REPORTED OUTCOMES

Patients reported a greater improvement in the frequency of atopic dermatitis symptoms, sleep disruption, and anxiety and depression symptoms vs placebo at Week 12, as measured by POEM ^1,3

7.5 point greater improvement in POEM scores reported with Cibinqo 200 mg vs placebo at Week 12 (nominal P<0.0001. Nominal p-values presented here are not multiplicity controlled and treatment differences could represent chance findings. Nominal p-values should not be interpreted as evidence of statistical significance).³

POEM outcomes at Week 12 (in combination with medicated topical therapy)^1,3,5

Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.²

Data limitations: Change from baseline in POEM is a prespecified secondary endpoint not controlled for multiplicity; therefore treatment differences could represent chance findings.^2,3

Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.^2,3

SECONDARY ENDPOINT – PATIENT REPORTED OUTCOMES

Patients reported improvement in health-related quality of life (defined as a 4-point improvement) from Baseline to Week 12 vs placebo^1,3

DLQI outcomes at Week 12 (in combination with medicated topical therapy)^1,3,6

Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.²

Data limitations: Change from baseline in DLQI is a prespecified secondary endpoint not controlled for multiplicity; therefore treatment differences could represent chance findings.^2,3

Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.^2,3

SECONDARY ENDPOINT – PATIENT REPORTED OUTCOMES

Patients reported improvement in sleep disruption, as measured by SCORAD sleep loss subscale vs placebo at Week 12³

SCORAD sleep loss subscale at Week 12 (in combination with medicated topical therapy)^3,7

Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids and other medicated topicals, starting on Day 1, to treat active lesions during the study, as per protocol guidance.²

SCORAD sleep loss subscale is a component of the SCORAD questionnaire.

Data limitations: Change from baseline in SCORAD sleep loss is a prespecified secondary endpoint not controlled for multiplicity; therefore treatment differences could represent chance findings.^2,3

Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.^2,3

Explore more

Safety

Access safety information for abrocitinib.

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; BSA=body surface area; CI=confidence interval; DLQI=Dermatology Life Quality Index; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; LSM=least squares mean; JAK=Janus kinase; OD=once daily; Q2W= once every two weeks; POEM=Patient-Oriented Eczema Measure; PP-NRS=Peak Pruritus Numerical Rating Scale; SCORAD=SCORing Atopic Dermatitis; SD=standard deviation.

Prescribing information:
Cibinqo (abrocitinib) Prescribing Information (Great Britain)

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.

Bieber T, et al. N Eng J Med 2021;384:1101–1112.

Bieber T, et al. N Eng J Med 2021;384:1101–1112 Supplementary appendix.

Data on file: REF-CIB1013, Cibinqo (abrocitinib) JADE COMPARE (Study B7451029), Proportion of Patients Achieving EASI Response ≥90% Improvement from Baseline at Week 12, nominal p-values

Data on File: REF-CIB1014, Cibinqo (abrocitinib) JADE COMPARE (Study B7451029) Least Squares Mean of Change from Baseline in POEM at Week 12, nominal p-values

Data on File: REF-CIB1015, Cibinqo (abrocitinib) JADE COMPARE (Study B7451029) Proportion of Subjects Achieving ≥4 Points Improvement from Baseline in DLQI at Week 12, nominal p-values

Data on File: REF-CIB1016, Cibinqo (abrocitinib) JADE COMPARE (Study B7451029) SCORAD sleep loss subscale, compared with placebo at week 12, nominal p-values

PP-CIB-GBR-1054. July 2023

Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc/product/12874/rmms. Patients treated with Cibinqo should be given the Patient Card.

JADE COMPARE

Study design
Efficacy results: Skin clearance (primary endpoint)
Efficacy results: Itch reduction (key secondary endpoint)
Efficacy results: Skin clearance (secondary endpoint)
Efficacy results: Patient reported outcomes (secondary endpoint)

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