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Abstract
Background
Special populations (SPs) involve people who require additional consideration in clinical research. Effectiveness of treatment or occurrence of side effects may be different in SPs with respect to not-SPs.
Objectives
To retrospectively compare the effectiveness and safety of dupilumab in AD treatment of SPs versus not-SPs.
Methods
A 52-weeks retrospective study was performed enrolling patients with a diagnosis of moderate-to-severe AD undergoing treatment with dupilumab at labeled dosage. Patients were divided in Group A (SPs patients) and Group B (not-SPs patients). Disease severity was assessed using Eczema Area Severity Index (EASI), Pruritus–Numerical Rating Scale (P-NRS), and Dermatology Life Quality Index (DLQI) score at baseline and after 4 weeks (W4), W16, W24, and W52.
Results
A total of 263 patients were enrolled and divided in Group A (25) and Group B (238). SPs included history of cancer, severe kidney failure, viral hepatitis, neurological diseases, acquired immunodeficiency syndrome, and transplanted patients. A statistically significant reduction of EASI, DLQI, and P-NRS was assessed in both groups at each follow-up visit (p < .0001), without significant differences between the groups. No differences were recorded for safety.
Conclusions
There are not significant differences between SPs and not-SPs as regards effectiveness and safety of dupilumab in AD management.
Acknowledgements
Patients have given written informed consent for publication of their case details. The article has not been previously published and is not currently submitted elsewhere.
Author contributions
Cataldo Patruno: conceptualization, validation, visualization, writing-original draft preparation, writing—review & editing, supervision. Luca Potestio: data curation, investigation, methodology, visualization, writing-original draft preparation. Massimiliano Scalvenzi: conceptualization, validation, visualization, writing-review & editing, supervision. Teresa Battista: data curation, investigation, methodology, visualization, writing-original draft preparation. Flavia Raia: data curation, investigation, methodology, visualization, writing-original draft preparation. Vincenzo Picone: data curation, investigation, methodology, visualization, writing-original draft preparation. Gabriella Fabbrocini: conceptualization, validation, visualization, writing-review & editing, supervision. Maddalena Napolitano: data curation, investigation, methodology, visualization, writing-original draft preparation, writing-review & editing, supervision.
All authors read and approved the final version of the manuscript.
Disclosure statement
C.P. acted as investigator, speaker, consultant, and advisory board member for AbbVie, Amgen, Eli Lilly, Leo Pharma, Novartis, Pfizer, Pierre Fabre, and Sanofi. G.F. has been principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Almirall, Celgene, Eli-Lilly, Leo Pharma, Novartis, Sanofi, and UCB. M.N. acted as speaker, consultant and advisory board member for Sanofi, Abbvie, Leo Pharma and Novartis, EliLilly. The remaining authors declare no conflict of interest.
Data availability statement
Data that support the findings of this study are available from the corresponding author, MN, upon reasonable request.