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

• DOI: 10.1007/s40257-023-00798-0
• Publication Date: 2023-06-15T18:01:51Z
• Authors: Andrea Chiricozzi; Michela Ortoncelli; Donatella Schena; Niccolò Gori; Silvia Mariel Fer...; Graziella Babino; Maddalena Napolitano; Maria Concetta Fa...; Luca Stingeni; Mariateresa Rossi; Marco Romanelli; Riccardo Balestri; Michele Pellegrino; Aurora Parodi; Alberto Maria Ber...; Giovanni Palazzo; Flaminia Antonelli; Annalisa Pitino; Giovanni Tripepi; Gabriella Fabbrocini; Anna Balato; Angelo Valerio Ma...; Giampiero Girolomoni; Simone Ribero; Ketty Peris
• Keywords: Interim analysis; Body surface area

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 safety are limited. This interim analysis aimed to assess throughout 48 weeks observation in a adult AD population. prospective study collected patients affected by moderate-to-severe treated with at dosage either 15 mg or 30 daily based physician decision. Upadacitinib was prescribed context national compassionate use programme. In this analysis, within patient comparisons continuous scores different scales (namely Eczema Area Severity Index [EASI], body surface area [BSA], Dermatology Life Quality [DLQI], Patient Oriented Measure [POEM], Numeric Rating Scale [NRS] subtests) were performed. The percentage achieving EASI 75, 90 100 Week 16, 32 also evaluated. One hundred forty-six included analysis. as monotherapy most cases (127/146, 87.0%). initially 118 146 (80.8%) 28/146 (19.2%) patients. A significant improvement clinical signs symptoms detected 16 period. responses achieved 87.6%, 69.1% 44.3% 48, associated sustained reduction mean values all physician-reported (EASI BSA) patient-reported (Itch- Sleep- Pain-NRS, DLQI, POEM) disease severity outcomes, up treatment. Treatment response observed upadacitinib-treated comparable that patients, revealing no statistical difference between two sub-cohorts. Through period, dose escalation 38/146 (26%) cases. Overall, 26 (17.8%) experienced least one adverse event (AE) during total, 29 AEs recorded them evaluated mild moderate, while 4 occurrence AE led drug discontinuation, total 7/146 (4.8%) dropouts. provides strong evidence obtained who had failed respond conventional biological systemic agents, through observation. demonstrated be advantageous terms flexibility shaped needs that, setting, might frequently change.