Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.
Fargnoli, M. C., Esposito, M., Ferrucci, S., Girolomoni, G., Offidani, A., Patrizi, A., Peris, K., Costanzo, R. M. A., Malara, G., Pellacani, G., Romanelli, M., Amerio, P., Cristaudo, A., Flori, M. L., Motolese, A., Betto, P., Patruno, C., Pigatto, P., Sirna, R., Stinco, G., Zalaudek, I., Bianchi, L., Boccaletti, V., Cannavo, S. P., Cusano, F., Lembo, S., Mozzillo, R., Gallo, R., Potenza, C., Rongioletti, F., Tiberio, R., Grieco, T., Micali, G., Persechino, S., Pettinato, M., Pucci, S., Savi, E., Stingeni, L., Romano, A., Argenziano, G., Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis, <<THE JOURNAL OF DERMATOLOGICAL TREATMENT>>, 2021; 32 (5): 507-513. [doi:10.1080/09546634.2019.1682503] [http://hdl.handle.net/10807/206146]
Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis
Fargnoli, Maria Concetta;Peris, Ketty;Costanzo, Rosa Maria Alba;Romanelli, Margherita;Zalaudek, Iris;Gallo, Rosanna;
2021
Abstract
Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.
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