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Om CIBINQO Om CIBINQOVirkningsmekanismeEffektEffektStudieprogram + Hvorfor bruke CIBINQOEffekt av CIBINQO med topikal behandlingEffekt av CIBINQO uten topikal behandlingHead-2-head: CIBINQO vs dupilumabEffekt hos ungdom (12-<18)Reduksjon i risiko for oppblussLangtids effektresultaterHvem kan bruke CIBINQOSkår i CIBINQO-studierSikkerhetSikkerhetSikkerhetsprofilUtvalgte bivirkningerUnormale laboratorieverdier Dosering & monitoreringDosering &
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Reduksjon i risiko for oppbluss

JADE REGIMEN var en responderberiket, randomisert, dobbeltblind, placebokontrollert fase 3-studie for å evaluere effekt og sikkerhet av Cibinqo hos 1233 voksne og ungdom med moderat til alvorlig AD som fikk CIBINQO 200 mg som monoterapi i en innledende 12-ukers åpen induksjonsperiode (OL), og responderne* (n=798) ble randomisert til CIBINQO 200 mg, CIBINQO 100 mg eller placebo i løpet av en 40-ukers vedlikeholdsperiode for å evaluere tap av respons eller protokolldefinert oppblussing† som krevde tillegsbehandling.1

Kontinuerlig Dosering
200 mg OL → 200 mg Double-Blinded

Dosereduksjon
200 mg OL → 100 mg Double-Blinded

Se studiedesign >

CIBINQO har vist seg å redusere risikoen for oppblussing betydelig† med begge dosene1

Hos pasienter som responderte* på 12-ukers behandling med åpen behandling med Cibinqo 200 mg:

Uansett om pasientene fortsatte med Cibinqo 200 mg eller dosen ble redusert til Cibinqo 100 mg, viste begge behandlingsarmene en signifikant lavere risiko for oppblussing† sammenlignet med placebo (seponert behandling) gjennom uke 521,2‡

†Protokolldefinert oppblussing som krever tilleggsbehandling: Et tap på minst 50 % av EASI-responsen oppnådd ved uke 12 (åpen induksjonsperiode) pluss en ny IGA-score på 2 eller høyere. 

Data limitations
Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus an IGA score of ≥2).

Responder criteria at week 12 were defined as achieving an IGA 0/1 with a reduction from baseline of ≥2 points and reaching EASI-75.JADE REGIMEN included a 12-week open-label induction period with CIBINQO 200 mg monotherapy, followed by a 40-week randomised maintenance period with CIBINQO 200 mg (continuing dose), CIBINQO 100 mg (reducing dose), or placebo (treatment withdrawn).AD=atopic dermatitis; OL=open label; QD=once a day; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment.CIBINQO 200 mg + TCS ble vist å raskt gjenvinne effekt når den ble brukt som tilleggsbehandling1§

IIProtokolldefinert oppblussing som krever tilleggsbehandling: Et tap på minst 50 % av EASI-responsen oppnådd ved uke 12 (åpen induksjonsperiode) pluss en ny IGA-score på 2 eller høyere.

Data limitations
During the rescue period, there was no control arm and all patients received CIBINQO 200 mg + TCS open label (patients knew they received active treatment).

Rescue treatment was CIBINQO 200 mg QD + any potency topical corticosteroids, topical calcineurin inhibitors, or phosphodiesterase-4 inhibitor, used per investigator’s usual practice.Recapture was defined as at least 75% improvement from rescue baseline (severity of AD at the moment of protocol-defined flare) in EASI score (EASI-75). JADE REGIMEN Studiedesign

Primary endpoint:

  • Loss of response or protocol-defined flare requiring rescue treatment 
Key secondary endpoint:
  • Loss of IGA 0/1 response
Biases
  • The induction period was open label; all subjects knew they were taking CIBINQO 200 mg
  • Patients may exhibit greater aggregate efficacy responses in open-label treatment periods than in double-blind, placebo-controlled studies
Data limitations
  • Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus IGA score of ≥2)
  • There is no consensus on a standardised definition of flare in a clinical and research setting
Eligible subjects had the option to enter JADE EXTEND, a long-term extension study. Patients who did not meet the responder criteria at the end of the induction period, as well as eligible patients who completed the maintenance period or the rescue period, had the option to enter JADE EXTEND.1,3TCS in the rescue period of JADE REGIMEN included any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, used per investigator’s usual practice in JADE REGIMEN.1EASI-75 response is defined as at least 75% improvement in EASI score from baseline.Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoadingVedvarende effektrespons opp til ~1 år4 Se resultaterLoadingReferences:Blauvelt A, Silverberg JI, Lynde CW, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112.CIBINQO SPCClinicalTrials.gov. Study to investigate efficacy and safety of PF-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects. ClinicalTrials.gov identifier: NCT03627767. Updated 20 January 2021. Accessed 9 May 2023. https://www.clinicaltrials.gov/ct2/show/NCT03627767Reich K, Silverberg JI, Papp K, et al. Long-term management of moderate-to-severe atopic dermatitis with abrocitinib: a phase 3 extension study (JADE EXTEND); British journal of dermatology, 2021, 185(3), e141‐e142

Se studiedesign >

CIBINQO har vist seg å redusere risikoen for oppblussing betydelig† med begge dosene1

Hos pasienter som responderte* på 12-ukers behandling med åpen behandling med Cibinqo 200 mg:

Uansett om pasientene fortsatte med Cibinqo 200 mg eller dosen ble redusert til Cibinqo 100 mg, viste begge behandlingsarmene en signifikant lavere risiko for oppblussing† sammenlignet med placebo (seponert behandling) gjennom uke 521,2‡

JADE REGIMEN viste at de fleste pasientene som initialt responderte på CIBINQO 200 mg OL, opprettholdt adekvat respons med redusert dosering.

†Protokolldefinert oppblussing som krever tilleggsbehandling: Et tap på minst 50 % av EASI-responsen oppnådd ved uke 12 (åpen induksjonsperiode) pluss en ny IGA-score på 2 eller høyere. 

Data limitations
Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus an IGA score of ≥2).

Responder criteria at week 12 were defined as achieving an IGA 0/1 with a reduction from baseline of ≥2 points and reaching EASI-75.JADE REGIMEN included a 12-week open-label induction period with CIBINQO 200 mg monotherapy, followed by a 40-week randomised maintenance period with CIBINQO 200 mg (continuing dose), CIBINQO 100 mg (reducing dose), or placebo (treatment withdrawn). AD=atopic dermatitis; QD=once a day; OL=open label; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment. CIBINQO 200 mg + TCS ble vist å raskt gjenvinne effekt når det ble brukt som tilleggsbehandling1§IIProtokolldefinert oppblussing som krever tilleggsbehandling: Et tap på minst 50 % av EASI-responsen oppnådd ved uke 12 (åpen induksjonsperiode) pluss en ny IGA-score på 2 eller høyere.

Data limitations
During the rescue period, there was no control arm and all patients received CIBINQO 200 mg + TCS open label (patients knew they received active treatment).

Rescue treatment was CIBINQO 200 mg QD + any potency topical corticosteroids, topical calcineurin inhibitors, or phosphodiesterase-4 inhibitor, used per investigator’s usual practice.
Recapture was defined as at least 75% improvement from rescue baseline (severity of AD at the moment of protocol-defined flare) in EASI score (EASI-75). JADE REGIMEN Studiedesign Tilpasset av Pfizer1

Primary endpoint:

  • Loss of response or protocol-defined flare requiring rescue treatment 
Key secondary endpoint:
  • Loss of IGA 0/1 response
Biases
  • The induction period was open label; all subjects knew they were taking CIBINQO 200 mg
  • Patients may exhibit greater aggregate efficacy responses in open-label treatment periods than in double-blind, placebo-controlled studies
Data limitations
  • Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus IGA score of ≥2)
  • There is no consensus on a standardised definition of flare in a clinical and research setting
Eligible subjects had the option to enter JADE EXTEND, a long-term extension study. Patients who did not meet the responder criteria at the end of the induction period, as well as eligible patients who completed the maintenance period or the rescue period, had the option to enter JADE EXTEND.1,4TCS in the rescue period of JADE REGIMEN included any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, used per investigator’s usual practice in JADE REGIMEN.1,3
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.Finn ut mer Har du spørsmål om effekt?
​​​​​​​ Be om en eRep-samtaleLoading Norske anbefalinger
[Endre bilde til et relevant ikon]  Hvem kan bruke CIBINQOLoadingReferences:Blauvelt A, Silverberg JI, Lynde CW, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112.CIBINQO SPCClinicalTrials.gov. Study to investigate efficacy and safety of PF-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects. ClinicalTrials.gov identifier: NCT03627767. Updated 20 January 2021. Accessed 9  May 2023. https://www.clinicaltrials.gov/ct2/show/NCT03627767
Effekt

Cibinqo brukerveiledning

Brosjyre med praktisk informasjon om dosering, dosejustering, overvåking, retningslinjer og sjekklister.​​​​​

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Preparatomtale
PP-CIB-NOR-0064 Mai 2023

Pfizer AS, Org.nr 915 213 596

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Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00


PP-BCP-NOR-0001 juni 2023

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