Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study.
Journal
Drugs in R&D
ISSN: 1179-6901
Titre abrégé: Drugs R D
Pays: New Zealand
ID NLM: 100883647
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
accepted:
18
07
2022
pubmed:
4
8
2022
medline:
9
9
2022
entrez:
3
8
2022
Statut:
ppublish
Résumé
The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab. Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy. Forty-three patients showed rapid and marked response to upadacitinib with significant reduction of all disease severity scores since the first follow-up visit. At week 16, Eczema Area and Severity Index (EASI) 75, EASI 90, and EASI 100 response was observed in 97.5%, 82.1%, and 69.2% of patients, respectively. EASI 90 response reflected the achievement of a clear or almost clear condition (POEM 0-2), self-evaluated by 79.5% of patients. Patients' quality of life improved as suggested by the achievement of DLQI 0/1 by 38.5% of patients at week 4, and by 76.9% at week 16. Elevated effectiveness and favorable safety of upadacitinib were confirmed in patients unresponsive to dupilumab, who were not included in upadacitinib trials.
Sections du résumé
BACKGROUND
BACKGROUND
The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab.
METHODS
METHODS
Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy.
RESULTS
RESULTS
Forty-three patients showed rapid and marked response to upadacitinib with significant reduction of all disease severity scores since the first follow-up visit. At week 16, Eczema Area and Severity Index (EASI) 75, EASI 90, and EASI 100 response was observed in 97.5%, 82.1%, and 69.2% of patients, respectively. EASI 90 response reflected the achievement of a clear or almost clear condition (POEM 0-2), self-evaluated by 79.5% of patients. Patients' quality of life improved as suggested by the achievement of DLQI 0/1 by 38.5% of patients at week 4, and by 76.9% at week 16.
CONCLUSION
CONCLUSIONS
Elevated effectiveness and favorable safety of upadacitinib were confirmed in patients unresponsive to dupilumab, who were not included in upadacitinib trials.
Identifiants
pubmed: 35922713
doi: 10.1007/s40268-022-00396-1
pii: 10.1007/s40268-022-00396-1
pmc: PMC9362214
doi:
Substances chimiques
Heterocyclic Compounds, 3-Ring
0
upadacitinib
4RA0KN46E0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
245-252Investigateurs
Alberto Maria Bertoldi
(AM)
Gabriella Fabbrocini
(G)
Maria Concetta Fargnoli
(MC)
Giampiero Girolomoni
(G)
Aurora Parodi
(A)
Pietro Quaglino
(P)
Informations de copyright
© 2022. The Author(s).
Références
Weidinger S, Beck LA, Bieber T, et al. Atopic dermatitis. Nat Rev Dis Primers. 2018;4:1.
doi: 10.1038/s41572-018-0001-z
Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: results from an international survey. Allergy. 2018;73:1284–93.
doi: 10.1111/all.13401
Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018;32:657–82.
doi: 10.1111/jdv.14891
Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. J Eur Acad Dermatol Venereol. 2018;32:850–78.
doi: 10.1111/jdv.14888
Simpson EL, Bieber T, Guttman-Yassky E, et al. Two Phase 3 trials of dupilumab versus placebo in AD. N Engl J Med. 2016;375:2335–48.
doi: 10.1056/NEJMoa1610020
Thaçi D, Simpson EL, Deleuran M, et al. Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2). J Dermatol Sci. 2019;94:266–75.
doi: 10.1016/j.jdermsci.2019.02.002
De Wijs LEM, Bosma AL, Erler NS, et al. Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. Br J Dermatol. 2020;182:418–26.
doi: 10.1111/bjd.18179
Faiz S, Giovannelli J, Podevin C, et al. Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. J Am Acad Dermatol. 2019;81:143–51.
doi: 10.1016/j.jaad.2019.02.053
Wang C, Kraus CN, Patel KG, et al. Real-world experience of dupilumab treatment for atopic dermatitis in adults: a retrospective analysis of patients’ records. Int J Dermatol. 2020;59:253–6.
doi: 10.1111/ijd.14573
Gori N, Chiricozzi A, Malvaso D, et al. Successful combination of systemic agents for the treatment of atopic dermatitis resistant to dupilumab therapy. Dermatology. 2021;237:535–41.
doi: 10.1159/000512890
Chiricozzi A, Gori N, Di Nardo L, et al. Therapeutic impact and management of persistent head and neck atopic dermatitis in dupilumab-treated patients. Dermatology. 2021. https://doi.org/10.1159/000519361 .
doi: 10.1159/000519361
pubmed: 34710866
Olesen CM, Holm JG, Nørreslet LB, et al. Treatment of atopic dermatitis with dupilumab: experience from a tertiary referral centre. J Eur Acad Dermatol Venereol. 2019;33:1562–8.
doi: 10.1111/jdv.15609
Armario-Hita JC, Pereyra-Rodriguez J, Silvestre JF, et al. Treatment of moderate-to-severe atopic dermatitis with dupilumab in real clinical practice: a multicentre, retrospective case series. Br J Dermatol. 2019;181:1072–4.
doi: 10.1111/bjd.18041
Ruiz-Villaverde R, Dominguez-Cruz J, Armario-Hita JC, et al. Fifty-two week follow-up safety and effectiveness results of dupilumab treatment of moderate-to-severe atopic dermatitis from a retrospective, multicentric series. Dermatol Ther. 2019;32: e12931.
doi: 10.1111/dth.12931
Jo CE, Finstad A, Georgakopoulos JR, et al. Facial and neck erythema associated with dupilumab treatment: a systematic review. J Am Acad Dermatol. 2021;84:1339–47.
doi: 10.1016/j.jaad.2021.01.012
He H, Guttman-Yassky E. JAK inhibitors for atopic dermatitis: an update. Am J Clin Dermatol. 2019;20:181–92.
doi: 10.1007/s40257-018-0413-2
Parmentier JM, Voss J, Graff C, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). MC Rheumatol. 2018;2:23.
Guttman-Yassky E, Thaçi D, Pangan AL, et al. Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020;145:877–84.
doi: 10.1016/j.jaci.2019.11.025
De Bruin-Weller M, Biedermann T, Bissonnette R, et al. Treat-to-target in atopic dermatitis: an international consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101(2):adv00402.
doi: 10.2340/00015555-3751
Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397:2151–68.
doi: 10.1016/S0140-6736(21)00588-2
Reich K, Teixeira HD, De Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021;397:2169–81.
doi: 10.1016/S0140-6736(21)00589-4
Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and safety of upadacitinib vs dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2021;157:1047–55.
doi: 10.1001/jamadermatol.2021.3023
Gao DX, Kahn JS, Cohen SR, et al. Results of switching from tofacitinib to upadacitinib in patients with atopic dermatitis: a retrospective medical record review. Dermatitis. 2021;32:e165–6.
doi: 10.1097/DER.0000000000000809
Licata G, Gambardella A, Tancredi V, et al. Face atopic dermatitis resistant to dupilumab: a case series of three patients successfully treated with upadacitinib. J Eur Acad Dermatol Venereol. 2021. https://doi.org/10.1111/jdv.17705 .
doi: 10.1111/jdv.17705
pubmed: 34553800
Nettis E, Ferrucci SM, Ortoncelli M, et al. Use of dupilumab for 543 adult patients with moderate-to-severe atopic dermatitis: a multicenter, retrospective study. J Investig Allergol Clin Immunol. 2020. https://doi.org/10.18176/jiaci.0641 .
doi: 10.18176/jiaci.0641
pubmed: 32856595
Fargnoli MC, Esposito M, Ferrucci S, et al. Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis. J Dermatolog Treat. 2021;32:507–13.
doi: 10.1080/09546634.2019.1682503
Tavecchio S, Angileri L, Giuffrida FP, et al. Efficacy of dupilumab on different phenotypes of atopic dermatitis: one-year experience of 221 patients. J Clin Med. 2020;9:2684.
doi: 10.3390/jcm9092684
Thaçi D, Simpson EL, Beck LA, et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016;387:40–52.
doi: 10.1016/S0140-6736(15)00388-8
Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTYAD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389:2287–303.
doi: 10.1016/S0140-6736(17)31191-1
Silverberg JI, De Bruin-Weller M, Bieber T, et al. Upadacitinib plus topical corticosteroids in atopic dermatitis: week-52 AD Up study results. J Allergy Clin Immunol. 2021;149(3):977-987.e14.
doi: 10.1016/j.jaci.2021.07.036