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Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study

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Abstract

Objective

The objective of this study was to assess the effectiveness and safety of dupilumab in treating elderly patients with atopic dermatitis from baseline to 52 weeks.

Methods

A retrospective observational real-life study was conducted in a group of elderly patients with severe atopic dermatitis treated with dupilumab for 52 weeks. Inclusion criteria were: age ≥ 65 years; diagnosis of atopic dermatitis made by an expert dermatologist; Eczema Area and Severity Index ≥ 24; and a contraindication, side effects, or failure to respond to cyclosporine. The primary outcome was the mean percentage reduction in the Eczema Area and Severity Index score from baseline to week 52. Secondary measures included the mean percentage reduction in the Pruritus and Sleep Numerical Rating Scales and the Dermatology Life Quality Index, and the types and rates of adverse events from baseline to week 52.

Results

One hundred and five patients were eligible for the study. Flexural dermatitis was the most frequent clinical phenotype (63.8%). The coexistence of more than one clinical phenotype was found in 70/105 (66.6%) patients. We observed a reduction in all disease severity scores from baseline to week 52 (p < 0.001). Adverse events were recorded in 30/105 (28.6%) patients, with conjunctivitis and injection-site reaction the most frequent.

Conclusions

In this study, dupilumab is an effective and safe treatment for the long-term management of atopic dermatitis in patients aged over 65 years.

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References

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Acknowledgements

DADE Study Group Collaborators: Angileri L, Bianchelli T, Borghi A, Calabrese G, Chello C, Dal Bello G, Dastoli S, Ferrillo M, Galluzzo M, Gori N, Hansel K, Macchia L, Piras V, Provenzano E, Ribero S, Romanelli M, Romita P.

Author information

Authors and Affiliations

  1. Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy

    Cataldo Patruno

  2. Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy

    Gabriella Fabbrocini

  3. Department of Physics, University of Naples Federico II, Naples, Italy

    Giuseppe Longo & Michele Delli Veneri

  4. Dermatology Unit, University of Campania, Naples, Italy

    Giuseppe Argenziano

  5. Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano, Italy

    Silvia Mariel Ferrucci

  6. Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy

    Luca Stingeni

  7. Dermatology, University of the Sacred Heart, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy

    Ketty Peris

  8. Dermatology Clinic, University of Turin, Turin, Italy

    Michela Ortoncelli

  9. Dermatology Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, Italy

    Annamaria Offidani

  10. UOC Dermatologia, AO Cosenza, Cosenza, Italy

    Giuseppe Fabrizio Amoruso

  11. Dermatology Unit, Policlinico Tor Vergata, Department of Systemic Medicine, Tor Vergata University of Rome, Rome, Italy

    Marina Talamonti

  12. Section of Dermatology, Department of Medicine, University of Verona, Verona, Italy

    Giampiero Girolomoni

  13. Dermatology Unit, Sapienza University of Rome, Rome, Italy

    Teresa Grieco

  14. Department of Dermatology, University of Pisa, Pisa, Italy

    Michela Iannone

  15. Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari Aldo Moro, Bari, Italy

    Eustachio Nettis

  16. Department of Biomedical Sciences and Human Oncology, University of Bari Aldo Moro, Bari, Italy

    Caterina Foti

  17. Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy

    Franco Rongioletti

  18. Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy

    Monica Corazza

  19. Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Via Francesco De Santis, snc., 86100, Campobasso, Italy

    Maddalena Napolitano

Authors
  1. Cataldo Patruno
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  2. Gabriella Fabbrocini
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  3. Giuseppe Longo
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  4. Giuseppe Argenziano
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  5. Silvia Mariel Ferrucci
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  6. Luca Stingeni
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  7. Ketty Peris
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  8. Michela Ortoncelli
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  9. Annamaria Offidani
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  10. Giuseppe Fabrizio Amoruso
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  11. Marina Talamonti
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  12. Giampiero Girolomoni
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  13. Teresa Grieco
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  14. Michela Iannone
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  15. Eustachio Nettis
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  16. Caterina Foti
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  17. Franco Rongioletti
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  18. Monica Corazza
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  19. Michele Delli Veneri
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  20. Maddalena Napolitano
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Consortia

Dupilumab for Atopic Dermatitis of the Elderly (DADE) Study Group

  • L Angileri
  • , T Bianchelli
  • , A Borghi
  • , G Calabrese
  • , C Chello
  • , G Dal Bello
  • , S Dastoli
  • , M Ferrillo
  • , M Galluzzo
  • , N Gori
  • , K Hansel
  • , L Macchia
  • , V Piras
  • , E Provenzano
  • , S Ribero
  • , M Romanelli
  •  & P Romita

Corresponding author

Correspondence to Maddalena Napolitano.

Ethics declarations

Funding

No funding or sponsorship was received for the conduct of this study or the preparation of this article.

Conflict of interest

Cataldo Patruno acted as investigator, speaker, consultant, and advisory board member for AbbVie, Eli Lilly, Novartis, Pfizer, Pierre Fabre, and Sanofi. Gabriella Fabbrocini has been the 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. Silvia Mariel Ferrucci is a speaker for Novartis and Sanofi Genzyme, is a principal investigator for Eli Lilly, AbbVie, and Sanofi Genzyme, and is an advisory member of Sanofi Genzyme. Luca Stingeni acted as a speaker and board member for Sanofi-Genzyme. Ketty Peris reports grants and personal fees from Almirall and AbbVie, and personal fees from Biogen, Lilly, Celgene, Galderma, Leo Pharma, Novartis, Pierre Fabre, Sanofi, Sandoz, Sun Pharma, and Janssen, outside the submitted work; Michela Ortoncelli acted as a speaker for AbbVie, Novartis, and Sanofi. Annamaria Offidani acted as an advisory board member, investigator, and speaker for AbbVie, Celgene, Eli Lilly, Galderma, Janssen, Novartis, Pfizer, Regeneron Pharmaceuticals, and Sanofi Genzyme. Giampiero Girolomoni has been a principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Almirall, Alphasights, Amgen, Biogen, Bristol-Meyers Squibb, Celgene, Celltrion, Eli-Lilly, Genzyme Gerson Lehrman Group, Guidepoint Global, Leo Pharma, Menlo Therapeutics, Novartis, OM Pharma, Pfizer, Regeneron, Samsung, Sandoz, and UCB. Eustachio Nettis in the past 5 years accepted a fee for organizing education for Sanofi. Caterina Foti acted as a speaker for AbbVie, Novartis, and Sanofi. Franco Rongioletti acted as a board advisor member for Sanofi. Maddalena Napolitano acted as a speaker, consultant, and advisory board member for Sanofi, Abbvie, Leo Pharma, and Novartis. Giuseppe Longo, Giuseppe Argenziano, Giuseppe Fabrizio Amoruso, Marina Talamonti, Teresa Grieco, Michela Iannone, Monica Corazza, and Michele Delli Veneri have no conflicts of interest that are directly relevant to the content of this article.

Ethics approval

The Ethics Committee of University of Naples Federico II (Naples, Italy) approved this study (Approval no. CE 116/20).

Consent to participate

Informed consent was obtained from all individual participants involved in the study.

Consent for publication

Consent for publication was obtained from both all individual participants and authors involved in the study.

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author contributions

CP, GF, and MN designed the study; GA, SF, LS, KP, MO, AO, GFA, MT, TG, MI, FR, and MC contributed to implementation of the research; GL and MDV contributed to the analysis of the results; and CP and MN wrote the manuscript in consultation with GF, GG, and EN.

Additional information

The members of DADE Study Group Collaborators are listed in the Acknowledgements section.

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Patruno, C., Fabbrocini, G., Longo, G. et al. Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study. Am J Clin Dermatol 22, 581–586 (2021). https://doi.org/10.1007/s40257-021-00597-5

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  • DOI: https://doi.org/10.1007/s40257-021-00597-5

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