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AboutAboutHow Cibinqo worksIntroducing CibinqoMOA OverviewPatient ProfilesPatient Profiles OverviewPatient Profile 1Patient Profile 2Patient Profile 3Patient Profile 4EfficacyEfficacyClinical EfficacyStudy OverviewJADE COMPAREJADE MONOJADE REGIMENJADE TEENJADE EXTENDSafety
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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.

PATIENT PROFILE 2Middle-aged mother with uncontrolled, severe eczematous lesions, resulting in self-consciousness and anxiety​​​​​​​Who is the patient?

This patient profile is fictional and has been produced for the purposes of medical education. Any actual or potential likeness to real individuals is unintentional.​​​​​​​

  • Caucasian female, 50 years old
  • Disease and treatment history: AD diagnosed during childhood, recurred in mid-40s with severe eczematous lesions. 4-year treatment journey including topical corticosteroids and TCI, phototherapy, ciclosporin and dupilumab 300 mg Q2W. Some response to dupilumab, but EASI reduction of 50% not achieved after 16 weeks of therapy
  • Clinical assessment: EASI=30; 50% BSA (including the face, neck, torso and arms)
  • Personal impact: Self-conscious about visible lesions around face and arms, resulting in anxiety
  • Preferences: Uneasy about injections; preference for a simple, non-invasive treatment, ideally without the need to use cream/ointment
    ​​​​​​​
Why consider Cibinqo (abrocitinib)?1.Significantly more patients achieved skin clearance at Week 12 with Cibinqo vs placebo1–4JADE MONO-1 AND MONO-2 (PRIMARY ENDPOINT)Proportion of patients achieving EASI-75, MONO-11,2
Scroll left to view table
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
Scroll left to view table
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)

Statistical significance was also achieved for Cibinqo 200 mg and 100 mg vs placebo for the other co-primary endpoint, IGA 0/1 at Week 12 in both JADE MONO-1 and MONO-2.

2. Significantly more patients achieved itch relief with Cibinqo vs placebo1–4JADE MONO-1 AND MONO-2 (KEY SECONDARY ENDPOINT)Proportion of patients achieving PP-NRS4, MONO-11,2Proportion of patients achieving PP-NRS4, MONO-21,3,43. Cibinqo provides durable skin clearance1,5JADE EXTEND (POST HOC ANALYSIS)EASI-75 at 48 weeks1

Among patients who achieved response after 12 weeks of treatment and entered JADE EXTEND*
Percentage of patients who maintained EASI-75 at Week 48

EASI-75 12 weeks after switching from dupilumab5

Among patients who received dupilumab and did not achieve an EASI-75 response at Week 16 in JADE COMPARE

Data limitations: Not all patients who completed the pivotal studies continued into the long-term extension study. Efficacy improvements seen in this study may be partially due to awareness of receiving active treatment and background medicated topical therapy. Response to Cibinqo 100 mg and 200 mg after previous treatment with dupilumab was assessed as a post-hoc analysis in the sub-set of patients who received dupilumab in JADE COMPARE and completed the study before entering JADE EXTEND.

Biases:​​​​​​​ JADE EXTEND is a parallel treatment assignment study of Cibinqo 200 mg and 100 mg with no placebo control, revealing the certainty of receiving treatment. The lack of placebo control limits the estimate of treatment effect. Due to patients having to complete a qualified parent study and remaining eligible to receive Cibinqo, there may be an enrichment in response based on the patient population.Explore morePatient 3

Young professional female with persistent, uncontrolled itching and lesions that are impacting her work.

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Patient 4

Teenage competitive swimmer suffering with regular disease flares and itching.

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This patient profile is fictional and has been produced for the purposes of medical education. Any actual or potential likeness to real individuals is unintentional.

*This analysis included patients who had received Cibinqo in MONO-1, MONO-2, COMPARE and subsequently enrolled in EXTEND, the long-term extension study. Patient was counted as non-responder after withdrawal.
The patient population included is small and therefore no conclusions can be drawn from these data.

AD=atopic dermatitis; BAS=body surface area; CI​​​​​=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; PP-NRS=Peak Pruritus Numerical Rating Scale; Q2W=once every two weeks; TCI=topical calcineurin inhibitor.

Prescribing information:​​​​​​​​​​​​​​
​​​​​​​
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 200 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 100 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 50 mg film-coated tablets.

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.Simpson E, et al. Lancet 2020;396(10246):255–266.Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873. Silverberg J, et al. JAMA Dermatol  2021; 156(8):863–873. Supplementary appendix. Shi V, et al. Poster #179 presented at: San Diego Dermatology Symposium. 11–13 June 2021.
PP-CIB-GBR-0057. October 2021

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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