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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.
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 AD, with a direct head-to-head comparison with dupilumab as an active comparator for itch relief at Week 2.1,2
*Patients used non-medicated emollient twice daily, starting at least 7 days before randomisation and continued throughout the trial.
†Patients used medicated topical therapy (once daily) such as low- or medium-potency topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors, starting on Day 1 and as per protocol guidance, to treat active lesions during the study.
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 ±14.6 |
| 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) |
• 161 (71.2) • 9 (4.0) • 53 (23.5) • 3 (1.3) |
• 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 • 138 (61.1) • 88 (38.9) |
• 0 • 0 • 0 • 138 (61.1) • 88 (38.9) |
• 0 • 0 • 0 • 138 (61.1) • 88 (38.9) |
| EASI score | 32.1 ±13.1 | 30.3 ±13.5 | 30.4 ±12.0 | 31.0 ±12.6 |
| BSA involvement, % | 50.8 ±23.0 | 50.8 ±23.0 | 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 | 20.9 ±5.3 | 20.4 ±6.1 |
| DLQI score | 16.3 ±6.6 | 15.5 ±6.4 | 15.5 ±6.4 | 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
| 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 | 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 dupilumab
For most patients, particularly those with severe disease, the recommended starting dose is 200 mg.
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
| IGA 0/1 at Week 12 | no./Total no. (%, 95% CI) |
|---|---|
| Cibinqo 200 mg | 106/219 (48.8%; 41.8–55.0 |
| Cibinqo 100 mg | 86/235 (36.6%; 30.4–42.8) |
| Dupilumab 300 mg | 88/241 (36.5%; 30.4–42.6) |
| Placebo | 18/129 (14.0%; 8.0–19.9) |
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
*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.
46.1% (101/219) of patients achieved EASI-90 with Cibinqo 200 mg.
| PP-NRS4 at Week 12 | no./Total no. (%, 95% CI) |
|---|---|
| Cibinqo 200 mg | 101/219 (46.1%; 39.5–52.7) |
| Cibinqo 100 mg | 86/235 (36.6%; 30.4–42.8) |
| Dupilumab 300 mg |
84/241 (34.9%; 28.8–40.9) |
| Placebo | 13/129 (10.1%; 4.9–15.3) |
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.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.
7.5 point greater improvement in POEM scores reported with Cibinqo 200 mg vs placebo at Week 12 (nominal P<0.0001).
Data limitations: Change from baseline in POEM is a prespecified secondary endpoint not controlled for multiplicity; therefore treatment differences could represent chance findings.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.
86.4% (190/220) of patients reported at least a 4-point improvement in DLQI score with Cibinqo 200 mg at Week 12.
Data limitations: Change from baseline in DLQI is a prespecified secondary endpoint not controlled for multiplicity; therefore treatment differences could represent chance findings.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.
62.4% greater improvement in reported SCORAD sleep loss subscale with Cibinqo 200 mg vs placebo at Week 12 (nominal P≤0.0001).
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.
Analyses shown are between Cibinqo and placebo. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between Cibinqo and dupilumab.
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.
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; PDE4=Type 4 cyclic nucleotide phosphodiesterase; 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. Patients treated with Cibinqo should be given the Patient Card.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard 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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PP-PFE-GBR-3863. November 2021