Andrew Blauvelt1, Jonathan I Silverberg2, Charles W Lynde3, Thomas Bieber4, Samantha Eisman5, Jacek Zdybski6, Walter Gubelin7, Eric L Simpson8, Fernando Valenzuela9, Paulo Ricardo Criado10, Mark G Lebwohl11, Claire Feeney12, Tahira Khan13, Pinaki Biswas14, Marco DiBonaventura14, Hernan Valdez14, Michael C Cameron14, Ricardo Rojo15. 1. Oregon Medical Research Center, Portland, Oregon. 2. The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia. 3. University of Toronto, Toronto, Ontario, Canada. 4. University Hospital of Bonn, Bonn, Germany. 5. Sinclair Dermatology, East Melbourne, Victoria, Australia. 6. Dermedic Jacek Zdybski, Ostrowiec Świętokrzyski, Poland. 7. Centro Medico Skinmed and Universidad de los Andes, Santiago, Chile. 8. Oregon Health & Science University, Portland, Oregon. 9. Department of Dermatology, University of Chile and Clinica Las Condes, Santiago, Chile. 10. Alergoskin Alergia e Dermatologia and Centro Universitário FMABC, Santo André, Brazil. 11. Icahn School of Medicine at Mount Sinai, New York, New York. 12. Pfizer Inc, Surrey, United Kingdom. 13. Pfizer Inc, Groton, Connecticut. 14. Pfizer Inc, New York, New York. 15. Pfizer Inc, New York, New York. Electronic address: ricardo.rojo@pfizer.com.
Abstract
BACKGROUND: The heterogeneous course of moderate-to-severe atopic dermatitis necessitates treatment flexibility. OBJECTIVE: We evaluated the maintenance of abrocitinib-induced response with continuous abrocitinib treatment, dose reduction or withdrawal, and response to treatment reintroduction following flare (JAK1 Atopic Dermatitis Efficacy and Safety [JADE] REGIMEN: National Clinical Trial 03627767). METHODS: Patients with moderate-to-severe atopic dermatitis responding to open-label abrocitinib 200 mg monotherapy for 12 weeks were randomly assigned in a 1:1:1 ratio to blinded abrocitinib (200 or 100 mg) or placebo for 40 weeks. Patients experiencing flare received rescue treatment (abrocitinib 200 mg plus topical therapy). RESULTS: Of 1233 patients, 798 responders to induction (64.7%) were randomly assigned. The flare probability during maintenance was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Among patients with flare in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo groups, 36.6%, 58.8%, and 81.6% regained investigator global assessment 0/1 response, respectively, and 55.0%, 74.5%, and 91.8% regained eczema area and severity index response, respectively, with rescue treatment. During maintenance, 63.2% and 54.0% of patients receiving abrocitinib 200 and 100 mg, respectively, experienced adverse events. LIMITATIONS: The definition of protocol-defined flare was not established, limiting the generalizability of findings. CONCLUSION: Induction treatment with abrocitinib was effective; most responders continuing abrocitinib did not flare. Rescue treatment with abrocitinib plus topical therapy effectively recaptured response.
BACKGROUND: The heterogeneous course of moderate-to-severe atopic dermatitis necessitates treatment flexibility. OBJECTIVE: We evaluated the maintenance of abrocitinib-induced response with continuous abrocitinib treatment, dose reduction or withdrawal, and response to treatment reintroduction following flare (JAK1 Atopic Dermatitis Efficacy and Safety [JADE] REGIMEN: National Clinical Trial 03627767). METHODS: Patients with moderate-to-severe atopic dermatitis responding to open-label abrocitinib 200 mg monotherapy for 12 weeks were randomly assigned in a 1:1:1 ratio to blinded abrocitinib (200 or 100 mg) or placebo for 40 weeks. Patients experiencing flare received rescue treatment (abrocitinib 200 mg plus topical therapy). RESULTS: Of 1233 patients, 798 responders to induction (64.7%) were randomly assigned. The flare probability during maintenance was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Among patients with flare in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo groups, 36.6%, 58.8%, and 81.6% regained investigator global assessment 0/1 response, respectively, and 55.0%, 74.5%, and 91.8% regained eczema area and severity index response, respectively, with rescue treatment. During maintenance, 63.2% and 54.0% of patients receiving abrocitinib 200 and 100 mg, respectively, experienced adverse events. LIMITATIONS: The definition of protocol-defined flare was not established, limiting the generalizability of findings. CONCLUSION: Induction treatment with abrocitinib was effective; most responders continuing abrocitinib did not flare. Rescue treatment with abrocitinib plus topical therapy effectively recaptured response.
Authors: Ahmed M Shawky; Faisal A Almalki; Ashraf N Abdalla; Ahmed H Abdelazeem; Ahmed M Gouda Journal: Pharmaceutics Date: 2022-05-06 Impact factor: 6.525
Authors: Elena Niculet; Ana Maria Pelin; Alexandru Nechifor; Cristian Onisor; Carmen Bobeica; Ioana Anca Stefanopol; Alin Laurentiu Tatu Journal: Ther Clin Risk Manag Date: 2022-04-13 Impact factor: 2.755
Authors: Muhammad Haisum Maqsood; Brittany N Weber; Rebecca H Haberman; Kristen I Lo Sicco; Sripal Bangalore; Michael S Garshick Journal: ACR Open Rheumatol Date: 2022-07-28