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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)
Cibinqo treatment durability in adults and adolescents ≥12 years:
• Durability of treatment response
• Risk of flaring following change from Cibinqo 200 mg to either 200 mg, 100 mg or placebo
• Studied across induction, maintenance, dose reduction, withdrawal and rescue therapy strategies
Cibinqo in combination with medicated topical therapy in patients 12–17 years
• Evaluated skin clearance and itch at Week 12
• Evaluated safety in adolescent population
Long-term safety and efficacy of Cibinqo in adults and adolescents aged ≥12 years
• Primary objective is to evaluate the long-term safety of Cibinqo
• Secondary objective to estimate the long-term efficacy of Cibinqo, including skin clearance and itch relief
Randomised, double-blind, double-dummy, active-controlled, head-to-head phase III trial that compared the efficacy and safety of Cibinqo 200 mg vs dupilumab in 727 adult patients with moderate-to-severe AD.
Header | Assessment |
Endpoint |
---|---|---|
Eczema Area and Severity Index (EASI)8 |
EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation and lichenification (scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. EASI score: 0 = no symptoms 72 = greatest severity EASI excluded scalp, palms and soles from the assessment/scoring. |
Co-primary endpoints |
Investigator's Global Assessment (IGA)9 |
A 5-point scale (0–4) reflecting a global consideration of the erythema, induration and scaling, giving an overall severity of AD. |
|
Peak Pruritus Numerical Rating Scale (PP-NRS)10 |
Patients keep a daily diary of itch severity, recording their worst itching due to AD over the past 24 hours. 0 = no itch 10 = worst possible itch imaginable |
Key secondary endpoint |
Header | Assessment | Endpoint |
---|---|---|
Patient-Oriented Eczema Measure (POEM)2 |
POEM is a validated 7-item patient-reported outcome measure used to assess the impact of AD recalled over the past week. It is used to evaluate and measure itch, sleep disturbance, bleeding skin, weeping/oozing skin, cracked skin, flaking skin and dry/rough skin, from the patient’s perspective. Scores range from 0–28, with higher scores indicating greater severity. |
Secondary endpoint |
SCORing Atopic Dermatitis (SCORAD)2 | SCORAD is a validated scoring index for AD, which combines extent (taking into account BSA affected by AD), severity, and subjective symptoms based on itch and sleep loss. Scores range from 0–103 with higher scores indicating greater severity. |
Secondary endpoint |
Dermatology Life Quality Index (DLQI)2 | DLQI is a validated general dermatology questionnaire that consists of 10 items to assess subject-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Scores range from 0–30, with higher scores indicating greater impact on quality of life. |
Secondary endpoint |
GENDER: Male
TRIAL: JADE MONO-2
DOSAGE: Cibinqo 100 mg
AGE: 24
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
GENDER: Female
TRIAL: JADE MONO-2
DOSAGE: Cibinqo 200 mg
AGE: 40
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
GENDER: Male
TRIAL: JADE MONO-2
DOSAGE: Cibinqo 200 mg
AGE: 22
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
GENDER: Male
TRIAL: JADE COMPARE
DOSAGE: Cibinqo 200 mg
AGE: 21
MEDICATED TOPICALS: Yes
BASELINE
AT WEEK 12
GENDER: Female
TRIAL: JADE MONO-2
DOSAGE: Cibinqo 100 mg
AGE: 28
MEDICATED TOPICALS: No
BASELINE
AT WEEK 12
Learn more about flexible dosing in patients on Cibinqo.
References:
1. Cibinqo (abrocitinib) Summary of Produce Characteristics.
2. Bieber T, et al. N Eng J Med 2021;384:1101-1112.
3. Simpson E, et al. Lancet 2020;396:P255-266.
4. Silverberg J, et al. JAMA Dermatol 2021;156(8):863-973.
5. Blauvelt A, et al. JAAD 2021; doi.org/10/1016/j.jaad.2021.05.075.
6. Eichenfield L, et al. JAMA dERMATOL 2021; doi:10.1001/jamadermatol.2021.2830.
7. ClinicalTrials.gov. NCT03422822. Available from: https://clinicaltrials.gov/ct2/show/NCT03422822.
8. Hanifin J, et al. Exp Dermatol 2001;10:11-18
9. Simpson E, et al. J Am Acad Dermatol 2020;83:839-846.
10. Yosipovitch G, et al. Br J Dermatol 2019;181:761769.
11. Reich K, et al. Lancet 2022;400:273-282.
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 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