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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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Effekt hos ungdom (12-<18)

NB! CIBINQO er kun godkjent for bruk hos voksne (> 18 år) med moderat til alvorlig AD i Norge.¹ 

JADE TEEN var en randomisert, dobbeltblind, placebokontrollert fase 3 klinisk studie som evaluerte effekt og sikkerhet av CIBINQO i kombinasjon med TCS vs placebo + TCS hos 285 unge pasienter med moderat til alvorlig AD.¹ 

Hudforbedring

Kløelindrende effekt

Se studiedesign >

De fleste ungdommer (>68% på 100/200 mg Cibinqo) oppnådde 75 % hudforbedring ved uke 12 med CIBINQO + TCS1,2

Sikkerhetsdata observert i JADE TEEN var i samsvar med sikkerhetsdata observert i pivotale studier.1,3-5

 Sikkerhetsprofil for CIBINQO Loading

Data limitations
EASI-75 response at week 12 was a prespecified, multiplicity-controlled primary endpoint. 
All other time points were prespecified, non–multiplicity-controlled secondary endpoints. Therefore, treatment differences could represent chance findings and no conclusions regarding other comparisons can be made. 

EASI-75 response is defined as at least 75% improvement in EASI score from baseline.
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE TEEN. Nonmedicated topicals were also required.1,6
AD=atopic dermatitis; EASI=Eczema Area and Severity Index; QD=once a day.Nesten 1 av 2 ungdom oppnådde hudforbedring med CIBINQO 200 mg + TCS ved uke 121

Sikkerhetsdata observert i JADE TEEN var i samsvar med sikkerhetsdata observert i pivotale studier.1,3-5

 Sikkerhetsprofil for CIBINQO LoadingTCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance. Nonmedicated topicals were also required.1,6
IGA=Investigator's Global Assessment.JADE TEEN Studiedesign

Study design¹

 Tilpasset av Pfizer1

Primære endepunkt:

  • EASI-75 respons ved uke 12 
  • IGA respons definert med skår av 0 eller 1, med en forbedring av ≥2 pooeng fra baseline ved uke 12
Viktige sekundære endepunkt:
  • PP-NRS4 respons ved uke 2, 4 og 12
  • PSAAD endring fra baseline ved uke 12
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.TCS includes low-to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE TEEN. Nonmedicated topicals were also required.1,6 At week 12, eligible subjects had the option to enter JADE EXTEND, the long-term extension study.​​​​​​​PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoadingRask og signifikant kløelindring hos ungdom¹ Se resultaterLoadingReferences:Eichenfield LF, Flohr C, Sidbury R, et al. Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial. [published correction appears in JAMA Dermatol. 2021 Oct 1;157(10):1246] JAMA Dermatol. 2021;157(10):1165-1173.CIBINQO SPCSimpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Eichenfield LF, Flohr C, Sidbury R, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial. JAMA Dermatol. 2021;157(10):1165-1173.

Se studiedesign >

Rask og signifikant kløelindring av CIBINQO + TCS hos ungdom¹

Sikkerhetsdata observert i JADE TEEN var i samsvar med sikkerhetsdata observert i pivotale studier.1-4

 Sikkerhetsprofil for CIBINQO LoadingTCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE TEEN. Nonmedicated topicals were also required.1,5
CIBINQO 100 mg was not statistically significant compared to placebo at week 4; therefore, all subsequent hypotheses for CIBINQO 100 mg were not considered statistically significant.5
PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.1
AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day.JADE TEEN Studiedesign

Studiedesign1

 Tilpasset av Pfizer1

Primære endepunkt:

  • EASI-75 respons ved uke 12 
  • IGA respons definert med skår av 0 eller 1, med en forbedring av ≥2 pooeng fra baseline ved uke 12 

Viktige sekundære endepunkt:

  • PP-NRS4 respons ved uke 2, 4 og 12
  • PSAAD endring fra baseline ved uke 12
EASI-75 response is defined as at least 75% improvement in EASI score from baseline. PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS. TCS includes low-to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE TEEN. Nonmedicated topicals were also required.1,5 At week 12, eligible subjects had the option to enter JADE EXTEND, the long-term extension study.​​​​​​​ PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoading Reduksjon i risiko for oppbluss6,7 Se resultaterLoadingReferences:Eichenfield LF, Flohr C, Sidbury R, et al. Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial. [published correction appears in JAMA Dermatol. 2021 Oct 1;157(10):1246] JAMA Dermatol. 2021;157(10):1165-1173.Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Eichenfield LF, Flohr C, Sidbury R, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial. JAMA Dermatol. 2021;157(10):1165-1173.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 SPC
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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PP-BCP-NOR-0001 juni 2023

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