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.

Original languageEnglish
JournalJournal of Dermatological Treatment
DOIs
Publication statusAccepted/In press - Jan 1 2019

Fingerprint

Atopic Dermatitis
Safety
Eczema
Sleep
Quality of Life
Dermatology
Conjunctivitis
Pruritus
Interleukin-4
SAR231893
Monoclonal Antibodies
Therapeutics

Keywords

  • Atopic dermatitis
  • dupilumab
  • real-life

ASJC Scopus subject areas

  • Dermatology

Cite this

Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis. / On behalf of the Dupilumab Italian National Access Program (Dup-INAP group).

In: Journal of Dermatological Treatment, 01.01.2019.

Research output: Contribution to journalArticle

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title = "Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis",
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.",
keywords = "Atopic dermatitis, dupilumab, real-life",
author = "{On behalf of the Dupilumab Italian National Access Program (Dup-INAP group)} and Fargnoli, {M. C.} and M. Esposito and S. Ferrucci and G. Girolomoni and A. Offidani and A. Patrizi and K. Peris and A. Costanzo and G. Malara and G. Pellacani and M. Romanelli and P. Amerio and A. Cristaudo and Flori, {M. L.} and A. Motolese and P. Betto and C. Patruno and P. Pigatto and R. Sirna and G. Stinco and I. Zalaudek and L. Bianchi and V. Boccaletti and Cannav{\`o}, {S. P.} and F. Cusano and S. Lembo and R. Mozzillo and R. Gallo and C. Potenza and F. Rongioletti and R. Tiberio and T. Grieco and G. Micali and S. Persechino and M. Pettinato and S. Pucci and E. Savi and L. Stingeni and A. Romano and G. Argenziano",
year = "2019",
month = "1",
day = "1",
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language = "English",
journal = "Journal of Dermatological Treatment",
issn = "0954-6634",
publisher = "Informa Healthcare",

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T1 - Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis

AU - On behalf of the Dupilumab Italian National Access Program (Dup-INAP group)

AU - Fargnoli, M. C.

AU - Esposito, M.

AU - Ferrucci, S.

AU - Girolomoni, G.

AU - Offidani, A.

AU - Patrizi, A.

AU - Peris, K.

AU - Costanzo, A.

AU - Malara, G.

AU - Pellacani, G.

AU - Romanelli, M.

AU - Amerio, P.

AU - Cristaudo, A.

AU - Flori, M. L.

AU - Motolese, A.

AU - Betto, P.

AU - Patruno, C.

AU - Pigatto, P.

AU - Sirna, R.

AU - Stinco, G.

AU - Zalaudek, I.

AU - Bianchi, L.

AU - Boccaletti, V.

AU - Cannavò, S. P.

AU - Cusano, F.

AU - Lembo, S.

AU - Mozzillo, R.

AU - Gallo, R.

AU - Potenza, C.

AU - Rongioletti, F.

AU - Tiberio, R.

AU - Grieco, T.

AU - Micali, G.

AU - Persechino, S.

AU - Pettinato, M.

AU - Pucci, S.

AU - Savi, E.

AU - Stingeni, L.

AU - Romano, A.

AU - Argenziano, G.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - Atopic dermatitis

KW - dupilumab

KW - real-life

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DO - 10.1080/09546634.2019.1682503

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