Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial
Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial
Background: Differences in atopic dermatitis (AD) disease course and manifestation with age may extend to treatment response. Objective: To evaluate response maintenance with continuous-/reduced-dose abrocitinib or withdrawal and response to treatment reintroduction after flare in adolescent and adult participants in JADE REGIMEN (NCT03627767). Methods: Adolescents (12–17 years) and adults with moderate-to-severe AD responding to abrocitinib 200-mg induction were randomly assigned to 40-week maintenance with abrocitinib (200 mg/100 mg) or placebo. Patients who experienced flare during maintenance received rescue treatment. Results: Of 246 adolescents and 981 adults, 145/246 (58.9%) and 655/981 (66.8%), respectively, responded to induction. Similar proportions of adolescents and adults experienced flare during maintenance with abrocitinib 200 mg (14.9%/16.9%), 100 mg (42.9%/38.9%), and placebo (75.5%/78.0%). From the abrocitinib 200-mg, 100-mg, and placebo arms, respectively, Eczema Area and Severity Index response was recaptured by 28.6%, 25.0%, and 52.9% of adolescents and 34.3%, 33.7%, and 58.0% of adults; Investigator’s Global Assessment response, by 42.9%, 50.0%, and 73.5% of adolescents and 34.3%, 50.6%, and 74.1% of adults. Abrocitinib had a similar safety profile regardless of age; nausea incidence was higher in adolescents. Limitations: Adolescents represented 20% of the trial population. Conclusion: Abrocitinib was effective in preventing flare in adolescents and adults.Clinicaltrials.gov listing: NCT03627767.
adolescent, adult, dermatitis, atopic/drug therapy, double-blind method, humans, Janus Kinase 1, severity of Illness Index, treatment outcome, adolescents, JADE REGIMEN, atopic dermatitis, Abrocitinib
Flohr, Carsten
3f23e285-22a5-4c8a-9848-e98dab555531
Cork, Michael J.
071e6a09-2869-45a5-a0b4-e47474610850
Ardern-Jones, Michael R.
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Eichenfield, Lawrence F.
d9e2cee4-4f31-4172-80ce-d32adbd33b45
Barbarot, Sébastien
6ba30461-1ad1-4df5-ae7d-22b573f90d9e
Feeney, Claire
6fc6ead5-617e-45be-9db4-b81da0321c4c
Rojo, Ricardo
64707c47-48e0-4412-9520-372903e5523a
Lazariciu, Irina
a85671dc-b7fd-43d5-a9e4-eba453c23719
Nesnas, John
1371cac0-6296-45c3-8bf0-2e879ecfdba0
27 April 2023
Flohr, Carsten
3f23e285-22a5-4c8a-9848-e98dab555531
Cork, Michael J.
071e6a09-2869-45a5-a0b4-e47474610850
Ardern-Jones, Michael R.
7ac43c24-94ab-4d19-ba69-afaa546bec90
Eichenfield, Lawrence F.
d9e2cee4-4f31-4172-80ce-d32adbd33b45
Barbarot, Sébastien
6ba30461-1ad1-4df5-ae7d-22b573f90d9e
Feeney, Claire
6fc6ead5-617e-45be-9db4-b81da0321c4c
Rojo, Ricardo
64707c47-48e0-4412-9520-372903e5523a
Lazariciu, Irina
a85671dc-b7fd-43d5-a9e4-eba453c23719
Nesnas, John
1371cac0-6296-45c3-8bf0-2e879ecfdba0
Flohr, Carsten, Cork, Michael J., Ardern-Jones, Michael R., Eichenfield, Lawrence F., Barbarot, Sébastien, Feeney, Claire, Rojo, Ricardo, Lazariciu, Irina and Nesnas, John
(2023)
Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial.
Journal of Dermatological Treatment, 34 (1), [2200866].
(doi:10.1080/09546634.2023.2200866).
Abstract
Background: Differences in atopic dermatitis (AD) disease course and manifestation with age may extend to treatment response. Objective: To evaluate response maintenance with continuous-/reduced-dose abrocitinib or withdrawal and response to treatment reintroduction after flare in adolescent and adult participants in JADE REGIMEN (NCT03627767). Methods: Adolescents (12–17 years) and adults with moderate-to-severe AD responding to abrocitinib 200-mg induction were randomly assigned to 40-week maintenance with abrocitinib (200 mg/100 mg) or placebo. Patients who experienced flare during maintenance received rescue treatment. Results: Of 246 adolescents and 981 adults, 145/246 (58.9%) and 655/981 (66.8%), respectively, responded to induction. Similar proportions of adolescents and adults experienced flare during maintenance with abrocitinib 200 mg (14.9%/16.9%), 100 mg (42.9%/38.9%), and placebo (75.5%/78.0%). From the abrocitinib 200-mg, 100-mg, and placebo arms, respectively, Eczema Area and Severity Index response was recaptured by 28.6%, 25.0%, and 52.9% of adolescents and 34.3%, 33.7%, and 58.0% of adults; Investigator’s Global Assessment response, by 42.9%, 50.0%, and 73.5% of adolescents and 34.3%, 50.6%, and 74.1% of adults. Abrocitinib had a similar safety profile regardless of age; nausea incidence was higher in adolescents. Limitations: Adolescents represented 20% of the trial population. Conclusion: Abrocitinib was effective in preventing flare in adolescents and adults.Clinicaltrials.gov listing: NCT03627767.
Text
Efficacy and safety of abrocitinib monotherapy in adolescents and adults a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and
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Accepted/In Press date: 1 March 2023
e-pub ahead of print date: 27 April 2023
Published date: 27 April 2023
Additional Information:
Funding Information:
Editorial/medical writing support under the guidance of the authors was provided by Megan K. Elder, PhD, at ApotheCom, San Francisco, CA, USA, and was funded by Pfizer Inc., New York, NY, USA, in accordance with Good Publication Practice (GPP 2022) guidelines (Ann Intern Med. 2022;10.7326/M22-1460).
Publisher Copyright:
© 2023 Pfizer Ltd. Published with license by Taylor & Francis Group, LLC.
Keywords:
adolescent, adult, dermatitis, atopic/drug therapy, double-blind method, humans, Janus Kinase 1, severity of Illness Index, treatment outcome, adolescents, JADE REGIMEN, atopic dermatitis, Abrocitinib
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Local EPrints ID: 477530
URI: http://eprints.soton.ac.uk/id/eprint/477530
ISSN: 0954-6634
PURE UUID: 71b0365c-7e15-4176-a256-eb9e25cc87e2
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Date deposited: 07 Jun 2023 17:14
Last modified: 17 Mar 2024 03:10
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Author:
Carsten Flohr
Author:
Michael J. Cork
Author:
Lawrence F. Eichenfield
Author:
Sébastien Barbarot
Author:
Claire Feeney
Author:
Ricardo Rojo
Author:
Irina Lazariciu
Author:
John Nesnas
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