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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 av CIBINQO uten topikal behandling

JADE MONO-1 og MONO-2 var to identisk utformede, randomiserte, dobbeltblinde, placebokontrollerte pivotale fase 3 kliniske studier som evaluerte effekt og sikkerhet av CIBINQO som monoterapi vs. placebo hos 778 voksne og unge pasienter med moderat til alvorlig AD.1,2

Hudforbedring

Kløelindrende effekt

Se studiedesign >

Signifikant hudforbedring, uten bruk av TCS1-3

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. 
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.
AD=atopic dermatitis; EASI=Eczema Area and Severity Index; QD=once a day.JADE MONO Study Design

Study design1,2

 Tilpasset av Pfizer1-2

    •     In JADE MONO-1 and MONO-2, a total of 124 adolescents were studied

Coprimary endpoints:

  • EASI-75 response at week 12 
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 
Key secondary endpoints:
  • PP-NRS4 response at weeks 2, 4, and 12
  • PSAAD change from baseline at week 12
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.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.At week 12, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week, off-treatment, follow-up period.4,5
PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Finn ut merHar du spørsmål om effekt? Be om en eRep-samtaleLoadingRask og sigifikant kløelindrende effekt hos pasienter2,5 Se resultaterLoadingReferences: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.CIBINQO SPCSimpson EL, Sinclair R, Forman S, et al. Supplementary appendix to: 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. Supplementary appendix to: Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.

Se studiedesign >

Rask og signifikant kløelindring gjennom uke 12 uten TCS1-3

Data limitations
Only PP-NRS4 responses at weeks 2, 4, and 12 were prespecified key secondary endpoints controlled for multiplicity.

Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.
PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.
AD=atopic dermatitis; TCS=topical corticosteroids; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day.JADE MONO Study Design

Study design1,2

 Tilpasset av Pfizer1-2

    •     In JADE MONO-1 and MONO-2, a total of 124 adolescents were studied

Coprimary endpoints:

  • EASI-75 response at week 12 
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 

Key secondary endpoints:

  • PP-NRS4 response at weeks 2, 4, and 12
  • PSAAD change from baseline at week 12
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.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. At week 12, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week, off-treatment, follow-up period.3,4PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoading Hudforbedring hos ungdom5 Se resultaterLoadingReferences: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.Silverberg JI, Simpson EL, Thyssen JP, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.Simpson EL, Sinclair R, Forman S, et al. Supplementary appendix to: 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.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.
Effekt

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