Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Mar-Apr;42(2):251-258.
doi: 10.1111/pde.15781. Epub 2024 Nov 11.

Low Infection Rates With Long-Term Dupilumab Treatment in Patients Aged 6 Months to 5 Years: An Open-Label Extension Study

Amy S Paller  1   2 , Michele Ramien  3   4 , Michael J Cork  5   6 , Eric L Simpson  7 , Lara Wine Lee  8 , Lawrence F Eichenfield  9   10 , Faisal A Khokhar  11 , Anna Coleman  12 , Guy Gherardi  13 , Zhen Chen  11 , Annie Zhang  14 , Sonya L Cyr  11
Affiliations
Clinical Trial

Low Infection Rates With Long-Term Dupilumab Treatment in Patients Aged 6 Months to 5 Years: An Open-Label Extension Study

Amy S Paller et al. Pediatr Dermatol. 2025 Mar-Apr.

Abstract

Objective: To evaluate long-term infection rates in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (AD) treated with dupilumab.

Methods: This was a post hoc analysis of an ongoing open-label extension (OLE) study of dupilumab. Pediatric patients aged 6 months to 5 years with moderate-to-severe AD who had previously taken part in the LIBERTY AD PRESCHOOL phase 2 and 3 clinical trials received weight-based subcutaneous dupilumab every 2 or 4 weeks. Exposure-adjusted infection rates after a median dupilumab exposure of 52 weeks are compared with data from the earlier randomized, placebo-controlled, 16-week LIBERTY AD PRESCHOOL phase 3 trial.

Results: Infection rates were overall lower in the OLE study compared with the dupilumab and placebo groups in the earlier 16-week trial, including total infections (101.0 patients/100 patient-years [PY]), nonherpetic skin infections (22.7 patients/100PY), herpetic infections (7.3 patients/100PY), and nonskin infections (92.9 patients/100PY). The frequency of severe and serious infections was low (3.1 patients/100PY), compared with 17.1 placebo-treated patients/100PY and 0 dupilumab-treated patients in the earlier 16-week trial, and no infections leading to treatment discontinuation were observed. Systemic anti-infective medication use (58.9 patients/100PY) was lower in the OLE study compared with both the dupilumab and placebo groups in the 16-week trial.

Conclusion: Overall, reduced infection rates are observed in infants and young children with moderate-to-severe AD treated with dupilumab long-term, supporting the known safety profile of dupilumab.

Keywords: atopic dermatitis; dupilumab; eczema; infections; pediatric dermatology.

PubMed Disclaimer

Conflict of interest statement

Dr. Paller reported serving as an investigator, consultant, and/or data and safety monitoring board member for AbbVie, Abeona Therapeutics, Amryt Pharma, Azitra, BioCryst, BMS, Boehringer Ingelheim, Castle Creek Biosciences, Catawba Research, Dermavant, Eli Lilly, Galderma, Incyte, InMed Pharmaceuticals, Janssen, Krystal Biotech, LEO Pharma, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWi Biotechnology, and UCB. Dr. Ramien reported serving as a consultant, speaker, and/or investigator for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. Dr. Cork reported serving as an investigator and/or consultant for AbbVie, Astellas Pharma, Boots, Dermavant, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, LEO Pharma, L'Oréal, Menlo Therapeutics, Novartis, Oxagen, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals Inc., and Sanofi. Dr. Simpson has received personal fees from AbbVie, Advances in Cosmetic and Medical Dermatology Hawaii, Amgen, AOBiome, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharmaceuticals, BMS, Boehringer Ingelheim, Boston Consulting Group, Collective Acumen, CorEvitas, Dermira, Eli Lilly, Evelo Biosciences, Evidera, Excerpta Medica, Forté Biosciences, Fraunhofer, Galderma, GSK, Incyte, Janssen, Johnson & Johnson, Kyowa Kirin, LEO Pharma, Maui Derm, Medscape, Merck, MJH Life Sciences, MLG Operating, Pfizer, Physicians World, PRImE, Regeneron Pharmaceuticals Inc., Revolutionizing Atopic Dermatitis, Roivant Sciences, Sanofi, Trevi Therapeutics, Valeant, Vindico Medical Education, and WebMD; and received grants from (or undertook a principal investigator role with) AbbVie, Amgen, Arcutis Biotherapeutics, Aslan Pharmaceuticals, Castle Creek Biosciences, CorEvitas, Dermavant, Dermira, Eli Lilly, Incyte, Kymab, Kyowa Kirin, National Jewish Health, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and Target RWE. Dr. Wine Lee has acted as an advisory board member consultant, investigator, data and safety monitoring board member, and/or speaker for AbbVie, Amgen, Amryt Pharma, Arcutis Biotherapeutics, BMS, Castle Creek Biosciences, Celgene, Eli Lilly, Galderma, Incyte, Kimberly‐Clark, Krystal Biotech, Mayne Pharma, Novartis, Pfizer, Pyramid Biosciences, Regeneron Pharmaceuticals Inc., Sanofi, Target Pharma, Trevi Therapeutics, and UCB. Dr. Eichenfield reported receiving honoraria for consulting services and/or research support from AbbVie, Amgen, Arcutis, Aslan Pharmaceuticals, Bausch, BMS, Castle Biosciences, Dermavant, Eli Lilly, Forté Pharma, Galderma, Incyte, Novartis, Otsuka, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and UCB. Drs Khokhar, Chen, and Cyr are employees and shareholders of Regeneron Pharmaceuticals Inc. Drs Coleman, Gherardi, and Zhang are employees of and may hold stock and/or stock options in Sanofi.

Figures

FIGURE 1
FIGURE 1
Exposure‐adjusted numbers of patients with ≥ 1 treatment‐emergent infection events during the study treatment period. aMedian treatment exposure. bSOC infections and infestations. cAdjudicated from the SOC infections and infestations. dHLT under the SOC infections and infestations. ePreferred Terms: Upper respiratory tract infection, pharyngitis streptococcal, viral upper respiratory tract infection, rhinitis, nasopharyngitis, and sinusitis. HLT, MedDRA High‐Level Term; nP/100PY, number of patients per 100 patient‐years; OLE, open‐label extension; q2w, every 2 weeks; q4w, every 4 weeks; SOC, MedDRA System Organ Class; TCS, topical corticosteroids.
FIGURE 2
FIGURE 2
Exposure‐adjusted number of patients using anti‐infective medication during the study treatment period. aMedian treatment exposure. nP/100PY, number of patients per 100 patient‐years; OLE, open‐label extension; q2w, every 2 weeks; q4w, every 4 weeks; TCS, topical corticosteroids.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Fiset P. O., Leung D. Y. M., and Hamid Q., “Immunopathology of Atopic Dermatitis,” Journal of Allergy and Clinical Immunology 118, no. 1 (2006): 287–290, 10.1016/j.jaci.2006.03.046. - DOI - PubMed
    1. Garcovich S., Maurelli M., Gisondi P., Peris K., Yosipovitch G., and Girolomoni G., “Pruritus as a Distinctive Feature of Type 2 Inflammation,” Vaccines 9, no. 3 (2021): 303, 10.3390/vaccines9030303. - DOI - PMC - PubMed
    1. Ellis C. N., Mancini A. J., Paller A. S., Simpson E. L., and Eichenfield L. F., “Understanding and Managing Atopic Dermatitis in Adult Patients,” Seminars in Cutaneous Medicine and Surgery 31, no. 3 Suppl (2012): S18–S22, 10.1016/j.sder.2012.07.006. - DOI - PubMed
    1. Silverberg J. I. and Silverberg N. B., “Childhood Atopic Dermatitis and Warts Are Associated With Increased Risk of Infection: A US Population‐Based Study,” Journal of Allergy and Clinical Immunology 133, no. 4 (2014): 1041–1047, 10.1016/j.jaci.2013.08.012. - DOI - PubMed
    1. Ong P. Y. and Leung D. Y. M., “Bacterial and Viral Infections in Atopic Dermatitis: A Comprehensive Review,” Clinical Reviews in Allergy & Immunology 51, no. 3 (2016): 329–337, 10.1007/s12016-016-8548-5. - DOI - PubMed

Publication types

Substances