Long-term Effectiveness and Safety of Upadacitinib for Atopic Dermatitis in a Real-world Setting: An Interim Analysis Through 48 Weeks of Observation.

Autor: Chiricozzi A; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy. chiricozziandrea@gmail.com.; UOC di Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. chiricozziandrea@gmail.com., Ortoncelli M; Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy., Schena D; Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy., Gori N; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.; UOC di Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Ferrucci SM; Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Babino G; Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy., Napolitano M; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy., Fargnoli MC; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.; Dermatology Unit, Ospedale San Salvatore, L'Aquila, Italy., Stingeni L; Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy., Rossi M; Dermatology Department, University of Brescia, Brescia, Italy., Romanelli M; Department of Dermatology, University of Pisa, Pisa, Italy., Balestri R; Division of Dermatology, Santa Chiara Hospital, Trento, Italy., Pellegrino M; Dermatology Unit, Misericordia Hospital, Grosseto, Italy., Parodi A; Department of Health and Science (Dissal), Section of Dermatology, University of Genoa, Polyclinic Hospital San Martino, IRCCS, Genoa, Italy., Bertoldi AM; Department of Dermatology, Hospital SS. Giovanni e Paolo, Venice, Italy., Palazzo G; Dermatology, Ospedale distrettuale 'A. Lo Dico', Matera, Italy., Antonelli F; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.; UOC di Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Pitino A; Institute of Clinical Physiology (IFC-CNR), Section of Rome, 00185, Rome, Italy., Tripepi G; Institute of Clinical Physiology (IFC-CNR), Section of Reggio Calabria, 89124, Reggio Calabria, Italy., Fabbrocini G; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy., Balato A; Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy., Marzano AV; Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy., Girolomoni G; Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy., Ribero S; Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy., Peris K; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.; UOC di Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Jazyk: angličtina
Zdroj: American journal of clinical dermatology [Am J Clin Dermatol] 2023 Nov; Vol. 24 (6), pp. 953-961. Date of Electronic Publication: 2023 Jun 15.
DOI: 10.1007/s40257-023-00798-0
Abstrakt: Background: Janus kinase (JAK) inhibitors, including upadacitinib, have been recently approved for the treatment of moderate-severe atopic dermatitis (AD) and real-world data on upadacitinib effectiveness and safety are limited. This interim analysis aimed to assess effectiveness and safety of upadacitinib throughout 48 weeks of observation in a real-world adult AD population.
Methods: This prospective study collected data on adult patients affected by moderate-to-severe AD and treated with upadacitinib at the dosage of either 15 mg or 30 mg daily based on the physician decision. Upadacitinib was prescribed in the context of a national compassionate use programme. In this interim analysis, within patient comparisons of continuous scores of different scales (namely Eczema Area and Severity Index [EASI], body surface area [BSA], Dermatology Life Quality Index [DLQI], Patient Oriented Eczema Measure [POEM], Numeric Rating Scale [NRS] subtests) were performed. The percentage of patients achieving EASI 75, EASI 90 and EASI 100 at Week 16, 32 and 48 was also evaluated.
Results: One hundred and forty-six patients were included in the analysis. Upadacitinib 15 mg or 30 mg daily was prescribed as monotherapy in most cases (127/146, 87.0%). Upadacitinib was initially prescribed at the dosage of 30 mg daily in 118 of 146 (80.8%) patients and 15 mg daily in 28/146 (19.2%) patients. A significant improvement in the clinical signs and symptoms of AD was detected by Week 16 and throughout the study period. EASI 75, EASI 90 and EASI 100 responses were achieved by 87.6%, 69.1% and 44.3% at Week 48, associated with a sustained reduction in the mean values of all physician-reported (EASI and BSA) and patient-reported (Itch- Sleep- and Pain-NRS, DLQI, and POEM) disease severity outcomes, up to 48 weeks of treatment. Treatment response observed in 15 mg upadacitinib-treated patients was comparable with that detected in 30 mg upadacitinib-treated patients, revealing no statistical difference between the two patient sub-cohorts. Through the observation period, dose reduction or escalation was observed in 38/146 (26%) of treated cases. Overall, 26 of 146 (17.8%) patients experienced at least one adverse event (AE) during the treatment period. In total, 29 AEs were recorded and most of them were evaluated as mild to moderate, while in 4 cases the occurrence of AE led to drug discontinuation, for a total of 7/146 (4.8%) dropouts.
Conclusion: This study provides strong evidence of a sustained response obtained by upadacitinib in AD patients, who had failed to respond to conventional or biological systemic agents, through 48 weeks of observation. Upadacitinib was also demonstrated to be advantageous in terms of flexibility in dose reduction or escalation as upadacitinib dose was shaped on clinical needs that, in a real-world setting, might frequently change.
(© 2023. The Author(s).)
Databáze: MEDLINE
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