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. 2023 Nov;24(6):953-961.
doi: 10.1007/s40257-023-00798-0. Epub 2023 Jun 15.

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

Andrea Chiricozzi  1   2 , Michela Ortoncelli  3 , Donatella Schena  4 , Niccolò Gori  5   6 , Silvia Mariel Ferrucci  7 , Graziella Babino  8 , Maddalena Napolitano  9 , Maria Concetta Fargnoli  10   11 , Luca Stingeni  12 , Mariateresa Rossi  13 , Marco Romanelli  14 , Riccardo Balestri  15 , Michele Pellegrino  16 , Aurora Parodi  17 , Alberto Maria Bertoldi  18 , Giovanni Palazzo  19 , Flaminia Antonelli  5   6 , Annalisa Pitino  20 , Giovanni Tripepi  21 , Gabriella Fabbrocini #  9 , Anna Balato  8 , Angelo Valerio Marzano  7   22 , Giampiero Girolomoni  4 , Simone Ribero  3 , Ketty Peris  5   6
Affiliations

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

Andrea Chiricozzi et al. Am J Clin Dermatol. 2023 Nov.

Erratum in

Abstract

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.

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Conflict of interest statement

Alberto Maria Bertoldi has received honoraria for lectures for AbbVie and Sanofi. Andrea Chiricozzi has served as advisory board member and consultant and has received fees and speaker's honoraria or has participated in clinical trials for AbbVie, Almirall, Bristol Myers Squibb, Leo Pharma, Lilly, Janssen, Novartis, Pfizer and Sanofi Genzyme. Maria Concetta Fargnoli has served on advisory boards, received honoraria for lectures and/or research grants from AMGEN, Almirall, Abbvie, Boehringer-Ingelheim, BMS, Galderma, Kyowa Kyrin, Leo Pharma, Pierre Fabre, UCB, Lilly, Pfizer, Janssen, MSD, Novartis, Sanofi-Regeneron, Sunpharma. Silvia Ferrucci has been principal investigator in clinical trials for ABBVIE, Almirall, Galderma, Leo Pharma, Sanofi, Amgen, Novartis, Bayer and received honoraria for lectures for Novartis and Menarini. Giampiero Girolomoni has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Leo Pharma, Merck Serono, Novartis, Pfizer, Samsung and Sanofi. Niccolò Gori served as advisory board member and received honoraria for lectures for AbbVie, Sanofi, and Leo-Pharma. Angelo Valerio Marzano reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi and UCB. Michela Ortoncelli has served as advisory board member and/or consultant and has received fees and speaker's honoraria or has participated for clinical studies for AbbVie, Leo Pharma, and Sanofi Genzyme. Ketty Peris has served on advisory board, received honoraria for lectures and/or research grants for Abbvie, Almirall, Lilly, Galderma, Leo Pharma, Pierre Fabre, Novartis, Sanofi, Sun Pharma, Janssen. Simone Ribero has served as advisory board member and/or consultant and has received fees and speaker's honoraria or has participated for clinical studies for AbbVie, Almirall, Leo Pharma, Elli Lilly, Novartis, Pfizer and Sanofi Genzyme. Marco Romanelli has served as advisory board member and consultant and has received fees and speaker's honoraria or has participated in clinical trials for Abbvie Almirall, Bristol Myers Squibb, Leo Pharma, Lilly, Janssen Novartis, Sanofi Genzyme. The other authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Percentages of upadacitinib-treated patients achieving Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90, and EASI 100 responses through 48 weeks of treatment
Fig. 2
Fig. 2
Treatment response was similar between 15 mg versus 30 mg upadacitinib dosage. EASI 75, EASI 90, and EASI 100 responses in patients treated with an initial dose of 15 mg (A) or 30 mg (B) upadacitinib. EASI Eczema Area and Severity Index
See this image and copyright information in PMC

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