JADE MONO
Cibinqo efficacy as monotherapy, without medicated topical therapy1–3
Co-primary endpoints:
Key secondary endpoints:
*Includes patients that were American Indian or Alaskan Native, Native Hawaiian or Pacific Islander, or multiracial.
†Patients were counted for each main category in an exclusive manner.
‡Topical agents includes corticosteroids and calcineurin inhibitors.
§Systemic agents includes mycophenolate mofetil, methotrexate, azathioprine, corticosteroids, ciclosporin and dupilumab.
¶Data were available for 77 patients in the placebo group, 155 patients in the Cibinqo 100 mg group, and 154 patients in the Cibinqo 200 mg group.
#Data were available for 68 patients in the placebo group, 137 patients in the Cibinqo 100 mg group, and 138 patients in the Cibinqo 200 mg group.
**Assessed in patients aged 18 years; data were available for 60 patients in the placebo group, 121 patients in the Cibinqo 100 mg group, and 119 patients in the Cibinqo 200 mg group.
††Assessed in patients aged <18 years; data were available for 16 patients in the placebo group, 32 patients in the Cibinqo 100 mg group, and 32 patients in the Cibinqo 200 mg group.
‡‡Data were available for 77 patients in the placebo group, 153 patients in the Cibinqo 100 mg group, and 153 patients in the Cibinqo 200 mg group.
*Patients were counted once for each main category in an exclusive manner, with systemic agents, biologics and/or topical agents taking precedence over anti-inflammatory topical agents alone.
INCLUSION CRITERIA2,3
• ≥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. Criteria for AD diagnosis 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, atopic dermatitis); along with ≥3 of 23 minor features specified in the criteria
• Have a documented history of inadequate response to treatment with topical medications, is not medically advisable, 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 CRITERIA2,3
• Active forms of other inflammatory skin diseases
• Prior treatment with any systemic JAK inhibitors
• 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
With Cibinqo, significantly more patients achieved skin clearance vs placebo1–3
Proportion of patients achieving EASI-75, MONO-11,2
EASI-75 at Week 12 |
no./Total no. (%, 95% CI |
---|---|
Cibinqo 200 mg |
96/153 (62.7%; 55.1–70.4) |
Cibinqo 100 mg |
62/156 (39.7%; 32.1–47.4) |
Placebo |
9/76 (11.8%; 4.6–19.1) |
Proportion of patients achieving EASI-75, MONO-21,3,4
EASI-75 at Week 12 |
no./Total no. (%, 95% CI) |
---|---|
Cibinqo 200 mg |
94/154 (61.0%; 53.3–68.7) |
Cibinqo 100 mg |
69/155 (44.5%; 36.7–52.3) |
Placebo |
8/77 (10.4%; 3.6–17.2) |
Proportion of patients achieving IGA 0/1, MONO-11,2
IGA 0/1 at Week 12 |
no./Total no. (%, 95% CI) |
---|---|
Cibinqo 200 mg |
67/153 (43.8%; 35.9–51.7) |
Cibinqo 100 mg |
37/156 (23.7%; 17.0–30.4) |
Placebo |
6/76 (7.9%; 1.8–14.0) |
Proportion of patients achieving IGA 0/1, MONO-21,3,4
IGA 0/1 at Week 12 |
no./Total no. (%; 95% CI) |
---|---|
Cibinqo 200 mg |
59/155 (38.1%; 30.4–45.7) |
Cibinqo 100 mg |
44/155 (28.4%; 21.3–35.5) |
Placebo |
7/77 (9.1%; 2.7–15.5) |
KEY SECONDARY ENDPOINT: ITCH RELIEF
Cibinqo achieved rapid and significant itch relief vs placebo1–3
Proportion of patients achieving PP-NRS4, MONO-11,2
Proportion of patients achieving PP-NRS4, MONO-21,3,4
Explore more
3,128 patients were treated with Cibinqo in clinical studies in AD representing 2,089 patient-years of exposure.1
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.
Learn more about flexible dosing in patients on Cibinqo.
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