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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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Langtids effektresultater

JADE EXTEND er en pågående langtids forlengelsesstudie med en 92-ukers primær behandlingsperiode etterfulgt av en åpen behandlingsperiode med variabel varighet for å evaluere sikkerhet og effekt av CIBINQO, med eller uten TCS, hos voksne og ungdom med moderat til alvorlig AD som tidligere har deltatt i en annen kvalifiserende JADE-studie.1

Vedvarende effektdata

Post-dupilumab responsrater

Se studiedesign >

Fra en interim-effektanalyse av langtids forlengelsesstudie

Vedvarende responsrater opp til 96 uker med begge doser av  CIBINQO1,2*

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, background medicated topicals, and/or patients who discontinued not being included in the efficacy analyses (as observed data).

Biases
This is a parallel treatment assignment study of CIBINQO 200 mg QD and CIBINQO 100 mg QD with no placebo control, revealing the certainty of receiving treatment. The lack of placebo control limits the estimate of treatment effect. Due to subjects having to complete a qualifying parent study and remaining eligible to receive CIBINQO, there may be an enrichment in response based on the patient population.

As observed data.+/- TCS includes any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician’s usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies, or biologics)
were prohibited during JADE EXTEND.1,2
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.
Visit on CIBINQO was based on windowing considering day 1 as the first day of receiving CIBINQO. 
AD=atopic dermatitis; EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day. JADE EXTEND Studiedesign  Tilpasset av Pfizer1 
  • JADE EXTEND is currently ongoing²
    • Results up to week 48 is available9,10
  • Qualifying parent studies that transition to the long-term extension trial include: JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE DARE,† JADE TEEN, and JADE REGIMEN1-4§
  • Patients studied in JADE EXTEND were allowed to use nonmedicated and medicated topical therapies as needed²

Primary endpoint5:

  • Long-term safety
Secondary endpoints5:
  • EASI-75 at all scheduled time points
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at all scheduled time points
  • PP-NRS4 at all scheduled time points
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 any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician’s usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies, or biologics) were prohibited during JADE EXTEND.1,2
All subjects enrolling from JADE DARE received CIBINQO 200 mg open-label in JADE EXTEND, including all patients from the dupilumab arm.1Subjects continue to receive CIBINQO in the long-term extension trial until availability of commercial CIBINQO or until the study is terminated in their respective country.3,6Subjects enrolling from the open-label period of JADE REGIMEN who were nonresponders continued receiving CIBINQO 200 mg open label in JADE EXTEND.5 IGA=Investigator's Global Assessment.Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoadingPost-dupilumab responsrater7,8  Se resultaterLoadingReferences:CIBINQO SPCReich 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‐e142Blauvelt A, Silverberg JI, Lynde CW, et al. Supplementary appendix to: 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. 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.ClinicalTrials.gov identifier: NCT03422822. Study to evaluate efficacy and safety of PF-04965842 with or without topical medications in subjects aged 12 years and older with moderate to severe atopic dermatitis (JADE EXTEND). Updated 22 February 2023. Accessed 9 March 2023. https://www.clinicaltrials.gov/ct2/show/NCT03422822Blauvelt 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.Shi V, Bhutani T, Deleuran M, et al. Abrocitinib in the treatment of moderate-to-severe atopic dermatitis refractory to dupilumab treatment: an analysis of JADE-EXTEND, a phase 3 long-term extension study. British journal of dermatology, 2021, 185(3), e138‐Shi VY, Bhutani T, Fonacier L, et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). Journal of the American Academy of Dermatology, 2022 issue 06, https://doi.org/10.1016/j.jaad.2022.04.009

Reich K, Silverberg JI, Papp K, et al. Abrocitinib efficacy and safety in patients with moderate-to-severe atopic dermatitis: Results from phase 3 studies, including the long-term extension JADE EXTEND study. Journal of the American Academy of Dermatology, 2023 Volume 37, issue10, Pages 2056-2066, https://doi.org/10.1111/jdv.19280

Reich K, Silverberg JI, Papp K, et al. Abrocitinib effect on patient-reported outcomes in patients with moderate-to-severe atopic dermatitis: Results from phase 3 studies, including the long-term extension JADE EXTEND study. Journal of the American Academy of Dermatology, 2023 Volume 37, issue10, Pages 2047-2055, https://doi.org/10.1111/jdv.19254

Se studiedesign >

Post hoc-analyse fra en interim-effektanalyse av langtids forlengelsesstudien (JADE Extend) 

Pasienter oppnådde hudforbedring med CIBINQO etter tidligere behandling med dupilumab1-4

Data limitations
EASI-75 response post-switch from dupilumab was a post hoc analysis. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons 
can be made. 
Prior response or nonresponse to dupilumab was not considered in the inclusion criteria for enrollment in JADE EXTEND. 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.

Biases
Response to CIBINQO 100 mg QD and CIBINQO 200 mg QD after previous treatment with dupilumab was a post hoc analysis. 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 subjects having to complete a qualifying parent study and remaining eligible to receive CIBINQO, there may be an enrichment in response based on the patient population.

EASI-75 response is defined as at least 75% improvement in EASI score from baseline.
+/- TCS includes any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician's usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies or biologics) were prohibited during JADE EXTEND.1,5Dupilumab nonresponders are those patients who did not achieve EASI-75 response at week 16.Dupilumab responders are those patients who achieved EASI-75 response at week 16.AD=atopic dermatitis; EASI=Eczema Area and Severity Index; QD=once a day. 
JADE EXTEND Studiedesign Long-term extension study design1,5 Tilpasset av Pfizer1 
  • JADE EXTEND is currently ongoing5
  • Qualifying parent studies that transition to the long-term extension trial include: JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE DARE,† JADE TEEN, and JADE REGIMEN1,5-7
  • Patients studied in JADE EXTEND were allowed to use nonmedicated and medicated topical therapies as needed5

Primary endpoint8:

  • Long-term safety
Secondary endpoints8:
  • EASI-75 at all scheduled time points
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at all scheduled time points
  • PP-NRS4 at all scheduled time points
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 any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician’s usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies, or biologics) were prohibited during JADE EXTEND.1,5All subjects enrolling from JADE DARE received CIBINQO 200 mg open-label in JADE EXTEND, including all patients from the dupilumab arm.1Subjects continue to receive CIBINQO in the long-term extension trial until availability of commercial CIBINQO or until the study is terminated in their respective country.6,9Subjects enrolling from the open-label period of JADE REGIMEN who were nonresponders continued receiving CIBINQO 200 mg open label in JADE EXTEND.8 IGA=Investigator's Global Assessment; PP-NRS=Peak Pruritus Numerical Rating Scale.Finn ut mer Har du spørsmål om effekt?
​​​​​​​ Be om en eRep-samtaleLoading Enkelheten med et oralt alternativ en gang daglig1,10Gå til Dosering LoadingReferences:CIBINQO SPCShi V, Bhutani T, Deleuran M, et al. Abrocitinib in the treatment of moderate-to-severe atopic dermatitis refractory to dupilumab treatment: an analysis of JADE-EXTEND, a phase 3 long-term extension study. British journal of dermatology, 2021, 185(3), e138‐Shi VY, Bhutani T, Fonacier L, et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). Journal of the American Academy of Dermatology, 2022 issue 06, https://doi.org/10.1016/j.jaad.2022.04.009Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Reich 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‐e142Blauvelt A, Silverberg JI, Lynde CW, et al. Supplementary appendix to: 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.Eichenfield LF, Flohr C, Sidbury R, et al. Efficacy and safety of abrocitinib in combination with topical therapy in adolescent patients 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.ClinicalTrials.gov identifier: NCT03422822. Study to evaluate efficacy and safety of PF-04965842 with or without topical medications in subjects aged 12 years and older with moderate to severe atopic dermatitis (JADE EXTEND). Updated 22 February 2023. Accessed 9 March 2023. https://www.clinicaltrials.gov/ct2/show/NCT03422822Blauvelt 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.Boeri M, Sutphin J, Hauber B, Cappelleri JC, Romero W, Di Bonaventura M. Quantifying patient preferences for systemic atopic dermatitis treatments using a discrete-choice experiment. J Dermatolog Treat. 2020;1-10. doi:10.1080/09546634.2020.1832185
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