Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry.
atopic dermatitis
hand eczema
quality of life
treatment
upadacitinib
Journal
Contact dermatitis
ISSN: 1600-0536
Titre abrégé: Contact Dermatitis
Pays: England
ID NLM: 7604950
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
revised:
12
12
2022
received:
23
09
2022
accepted:
05
01
2023
medline:
5
4
2023
pubmed:
10
1
2023
entrez:
9
1
2023
Statut:
ppublish
Résumé
Real-world data on the effectiveness of upadacitinib on atopic dermatitis (AD), hand eczema (HE) and HE in the context of AD are limited. To evaluate the effectiveness and safety of upadacitinib on AD and on HE in patients with AD. This prospective observational cohort study includes clinical outcomes: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Hand Eczema Severity Index (HECSI), Photographic guide; and PROMs: average pruritus and pain Numeric Rating Scale (NRS) score of the past week, Patient-Oriented Eczema Measure (POEM), Patient-Oriented Eczema, Dermatology Life Quality Index (DLQI), Atopic Dermatitis Control Tool (ADCT), Patient Global Assessment of Disease (PGAD), Quality Of Life Hand Eczema Questionnaire (QOLHEQ) at baseline, Week 4, and Week 16 of upadacitinib-treated patients. Adverse events were monitored during each visit. Thirty-eight patients were included, of which 32 patients had HE. At Week 16, EASI-75 was achieved by 50.0%. Absolute cutoff score NRS-pruritus ≤4 was reached by 62.5%, POEM ≤7 by 37.5%, DLQI ≤5 by 59.4%, ADCT <7 by 68.8%, and PGAD rating of at least 'good' by 53.1%. HECSI-75 was achieved by 59.3% and (almost) clear on the Photographic guide by 74.1%. The minimally important change in QOLHEQ was achieved by 57.9%. Sub-analysis in patients with concomitant irritant contact dermatitis showed no differences. Safety analysis showed no new findings compared to clinical trials. Upadacitinib can be an effective treatment for patients with AD and concomitant HE in daily practice. Future studies should focus on the effectiveness of upadacitinib on chronic HE, especially on the different etiological subtypes of HE, including HE in non-atopic individuals.
Sections du résumé
BACKGROUND
BACKGROUND
Real-world data on the effectiveness of upadacitinib on atopic dermatitis (AD), hand eczema (HE) and HE in the context of AD are limited.
OBJECTIVES
OBJECTIVE
To evaluate the effectiveness and safety of upadacitinib on AD and on HE in patients with AD.
METHODS
METHODS
This prospective observational cohort study includes clinical outcomes: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Hand Eczema Severity Index (HECSI), Photographic guide; and PROMs: average pruritus and pain Numeric Rating Scale (NRS) score of the past week, Patient-Oriented Eczema Measure (POEM), Patient-Oriented Eczema, Dermatology Life Quality Index (DLQI), Atopic Dermatitis Control Tool (ADCT), Patient Global Assessment of Disease (PGAD), Quality Of Life Hand Eczema Questionnaire (QOLHEQ) at baseline, Week 4, and Week 16 of upadacitinib-treated patients. Adverse events were monitored during each visit.
RESULTS
RESULTS
Thirty-eight patients were included, of which 32 patients had HE. At Week 16, EASI-75 was achieved by 50.0%. Absolute cutoff score NRS-pruritus ≤4 was reached by 62.5%, POEM ≤7 by 37.5%, DLQI ≤5 by 59.4%, ADCT <7 by 68.8%, and PGAD rating of at least 'good' by 53.1%. HECSI-75 was achieved by 59.3% and (almost) clear on the Photographic guide by 74.1%. The minimally important change in QOLHEQ was achieved by 57.9%. Sub-analysis in patients with concomitant irritant contact dermatitis showed no differences. Safety analysis showed no new findings compared to clinical trials.
CONCLUSIONS
CONCLUSIONS
Upadacitinib can be an effective treatment for patients with AD and concomitant HE in daily practice. Future studies should focus on the effectiveness of upadacitinib on chronic HE, especially on the different etiological subtypes of HE, including HE in non-atopic individuals.
Substances chimiques
upadacitinib
4RA0KN46E0
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
351-362Subventions
Organisme : Pfizer
Organisme : Sanofi
Informations de copyright
© 2023 The Authors. Contact Dermatitis published by John Wiley & Sons Ltd.
Références
Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: results from an international survey. Allergy. 2018;73(6):1284-1293.
Quaade AS, Simonsen AB, Halling AS, Thyssen JP, Johansen JD. Prevalence, incidence, and severity of hand eczema in the general population - a systematic review and meta-analysis. Contact Dermatitis. 2021;84(6):361-374.
Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and severity of hand eczema in the Dutch general population: a cross-sectional, questionnaire study within the lifelines cohort study. Acta Derm Venereol. 2022;102:adv00626.
Simpson EL, Thompson MM, Hanifin JM. Prevalence and morphology of hand eczema in patients with atopic dermatitis. Dermatitis. 2006;17(3):123-127.
Ruff SMD, Engebretsen KA, Zachariae C, et al. The association between atopic dermatitis and hand eczema: a systematic review and meta-analysis. Br J Dermatol. 2018;178(4):879-888.
Agner T, Aalto-Korte K, Andersen KE, et al. Classification of hand eczema. J Eur Acad Dermatol Venereol. 2015;29(12):2417-2422.
Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
Moberg C, Alderling M, Meding B. Hand eczema and quality of life: a population-based study. Br J Dermatol. 2009;161(2):397-403.
Voorberg AN, Romeijn GLE, de Bruin-Weller MS, Schuttelaar MLA. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis-52 week results from the Dutch BioDay Registry. Contact Dermatitis. 2022;87:185-191.
Pereyra-Rodriguez JJ, Herranz P, Figueras-Nart I, et al. Treatment of severe atopic dermatitis with upadacitinib in real clinical practice. Short-term efficacy and safety results. J Investig Allergol Clin Immunol. 2023;33(3). Online ahead of print.
Feraru G, Nevet MJ, Samuelov L, et al. Real-life experience of upadacitinib for the treatment of adult patients with moderate-to-severe atopic dermatitis - a case series. J Eur Acad Dermatol Venereol. 2022;36:e832-e833.
Dal Bello G, Schena D, Girolomoni G. Upadacitinib in patients with resistant atopic dermatitis: a retrospective case-series. J Eur Acad Dermatol Venereol. 2022;36:1499-1500.
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(6):e165-e166.
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. 2022;36(2):e150-e152.
Kozera E, Flora A, Stewart T, et al. Dupilumab-associated head and neck dermatitis resolves temporarily with itraconazole therapy and rapidly with transition to upadacitinib, with Malassezia-specific immunoglobulin E levels mirroring clinical response. J Am Acad Dermatol. 2022;88:255-257.
Hayama K, Fujita H. Improvement of dupilumab-associated conjunctivitis after switching to upadacitinib in a patient with atopic dermatitis. Dermatol Ther. 2022;35(7):e15575.
Napolitano M, Fabbrocini G, Genco L, Martora F, Potestio L, Patruno C. Rapid improvement in pruritus in atopic dermatitis patients treated with upadacitinib: a real-life experience. J Eur Acad Dermatol Venereol. 2022;36:1497-1498.
Cantelli M, Martora F, Patruno C, Nappa P, Fabbrocini G, Napolitano M. Upadacitinib improved alopecia areata in a patient with atopic dermatitis: a case report. Dermatol Ther. 2022;35(4):e15346.
Nguyen J, Chen JK, Honari G, Pol-Rodriguez M, Ko JM, Chiou AS. Bridging to a selective Janus kinase 1 inhibitor in severe atopic dermatitis: an instructive case with upadacitinib. JAAD Case Rep. 2021;7:65-67.
Kiely L, Bowe S, O'Connor C, Bennett M, Bourke J, Murphy M. Novel agents for atopic dermatitis in patients over 50 years of age: a case series. Dermatol Ther. 2021;34(2):e14890.
Chiricozzi A, Gori N, Narcisi A, et al. Effectiveness and safety of upadacitinib in the treatment of moderate-severe atopic dermatitis: a multicentric, prospective, real-world, cohort study. Drugs R D. 2022;22:245-252.
Gambardella A, Licata G, Calabrese G, De Rosa A, Alfano R, Argenziano G. Dual efficacy of upadacitinib in 2 patients with concomitant severe atopic dermatitis and alopecia areata. Dermatitis. 2021;32(1 S):e85-e86.
Hagino T, Saeki H, Kanda N. The efficacy and safety of upadacitinib treatment for moderate to severe atopic dermatitis in real-world practice in Japan. J Dermatol. 2022;49(11):1158-1167.
Domeingroep Allergie en eczeem, domeingroep Kinderdermatologie, VMCE. Upadacitinib (standpunt). Available from: Standpunten en leidraden (nvdv.nl). Assessed July 2022.
Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001;10(1):11-18.
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.
Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502-507.
Silverberg JI. Validity and reliability of a novel numeric rating scale to measure skin-pain in adults with atopic dermatitis. Arch Dermatol Res. 2021;313(10):855-861.
Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004;140(12):1513-1519.
Finlay AY, Khan GK. Dermatology life quality index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.
Pariser DM, Simpson EL, Gadkari A, et al. Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the atopic dermatitis control tool (ADCT). Curr Med Res Opin. 2020;36(3):367-376.
Griffiths C, de Bruin-Weller M, Deleuran M, et al. Dupilumab in adults with moderate-to-severe atopic dermatitis and prior use of systemic non-steroidal immunosuppressants: analysis of four phase 3 trials. Dermatol Ther (Heidelb). 2021;11(4):1357-1372.
Held E, Skoet R, Johansen JD, Agner T. The hand eczema severity index (HECSI): a scoring system for clinical assessment of hand eczema. A study of inter- and intraobserver reliability. Br J Dermatol. 2005;152(2):302-307.
Coenraads PJ, Van Der Walle H, Thestrup-Pedersen K, et al. Construction and validation of a photographic guide for assessing severity of chronic hand dermatitis. Br J Dermatol. 2005;152(2):296-301.
Oosterhaven JAF, Ofenloch RF, Schuttelaar MLA. Validation of the Dutch quality of life in hand eczema questionnaire (QOLHEQ). Br J Dermatol. 2020;183(1):86-95.
Oosterhaven JAF, Ofenloch RF, Schuttelaar MLA. Interpretability of the quality of life in hand eczema questionnaire. J Invest Dermatol. 2020;140(4):785-790.
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin. TRGS 401: Risks Resulting from Skin Contact-Identification, Assessment, Measures [Internet]. 2008. Assessed July 2022. https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/TRGS-401.html
Behroozy A, Keegel TG. Wet-work exposure: a main risk factor for occupational hand dermatitis. Saf Health Work. 2014;5(4):175-180.
Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Available from: Global Initiative for Asthma (GINA) (ginasthma.org). Assessed July 2022.
Bousquet J, Khalteav N, Cruz AA. An introduction of allergic rhinitis and its impact on asthma (ARIA) 2008 update. Allergy. 2008;63(86):8-160.
Freites-Martinez A, Santana N, Arias-Santiago S, Viera A. Using the common terminology criteria for adverse events (CTCAE - version 5.0) to evaluate the severity of adverse events of anticancer therapies. Actas Dermosifiliogr (Engl Ed). 2021;112(1):90-92.
Donders AR, van der Heijden GJ, Stijnen T, Moons KG. Review: a gentle introduction to imputation of missing values. J Clin Epidemiol. 2006;59(10):1087-1091.
Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007;8(3):206-213.
Simpson EL, Rahawi K, Hu X. Effect of Upadacitinib on Hand Eczema in Patients With Moderate-to-Severe Atopic Dermatitis: Results from Two Phase 3 Trials (Measure Up 1 and Measure Up 2). Presented at the 30th European Academy of Dermatology and Venereology Congress, September 29-October 2, 2021, EADV Virtual Congress (e-poster, unpublished).
He H, Guttman-Yassky E. JAK inhibitors for atopic dermatitis: an update. Am J Clin Dermatol. 2019;20(2):181-192.
Cheng J, Facheris P, Ungar B, Guttman-Yassky E. Current emerging and investigational drugs for the treatment of chronic hand eczema. Expert Opin Investig Drugs. 2022;1-11:843-853.
Worm M, Bauer A, Elsner P, Mahler V, Molin S, Nielsen TSS. Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study. Br J Dermatol. 2020;182(5):1103-1110.
Worm M, Thyssen JP, Schliemann S, et al. The pan-JAK inhibitor delgocitinib in a cream formulation demonstrates dose response in chronic hand eczema in a 16-week randomized phase IIb trial. Br J Dermatol. 2022;187(1):42-51.
Business Wire. Asana biosciences announces positive topline results from phase 2b study of oral JAK-SYK inhibitor gusacitinib (ASN002) in patients with chronic hand eczema: rapid and significant improvement demonstrated [press release]. Available from: Asana BioSciences Announces Positive Topline Results from Phase 2b Study of Oral JAK/SYK Inhibitor Gusacitinib (ASN002) in Patients with Chronic Hand Eczema: Rapid and Significant Improvement Demonstrated | Business Wire. Assessed July 2022.
Simpson E, Eckert L, Gadkari A, et al. Validation of the atopic dermatitis control tool (ADCT(c)) using a longitudinal survey of biologic-treated patients with atopic dermatitis. BMC Dermatol. 2019;19(1):15.
Strober B, Mallya EG, Yang M, et al. Treatment outcomes associated with dupilumab use in patients with atopic dermatitis: 1-year results from the RELIEVE-AD study. JAMA Dermatol. 2022;158(2):142-150.
Nikiphorou E, Radner H, Chatzidionysiou K, et al. Patient global assessment in measuring disease activity in rheumatoid arthritis: a review of the literature. Arthritis Res Ther. 2016;18(1):251.
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 (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
Smoking Pack Years. Available from: Home | Smoking Pack Years. Assessed July 2022.
Dittmar D, Ofenloch RF, Schuttelaar MLA. Persistence of contact allergy: a retrospective analysis. Contact Dermatitis. 2018;78(2):143-150.
Oosterhaven JAF, Flach PA, Bultmann U, Schuttelaar MLA. Presenteeism in a Dutch hand eczema population - a cross-sectional survey. Contact Dermatitis. 2018;79(1):10-19.