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Adverse event reporting can be found at the bottom of the page
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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 a 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 a history of malignancy). (Cibinqo Summary of Product Characteristics)
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
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.
| 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.
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
Adapted from Bieber T, et al. N Eng J Med 2021;384:1101–1112.
| 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
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
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
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
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
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
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
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
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
Access safety information for abrocitinib.
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.
Learn more about flexible dosing in patients on Cibinqo.
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.
References:
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.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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