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. 2025 Jan 17:12:1524962.
doi: 10.3389/fped.2024.1524962. eCollection 2024.

Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study

Yanhua Chen #  1 , Jiang Ni #  2 , Ming Li  3 , Yuan Hong  1 , Kouzhu Zhu  1 , Rong Hong  1 , Li Deng  1 , Zhijie Li  4 , Jie Pu  4 , Ting Yang  4 , Yan Wang  1
Affiliations

Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study

Yanhua Chen et al. Front Pediatr. .

Abstract

Objective: This study analyzes the occurrence and characteristics of adverse drug reactions (ADRs) of dupilumab in children in a real-world setting. It aims to enhance clinical practice and minimize medication safety risks in pediatric patients.

Methods: This prospective study included children receiving dupilumab in the hospital between January 2022 and December 2023. Information on ADRs was collected and univariate and multivariate analyses were employed to identify high-risk factors for the occurrence of adverse effects in dupilumab treatment.

Results: A total of 65 ADRs occurred in 1,103 treatments in 127 patients, with an incidence of 27.56% (35/127). A total of 62 patients aged 6 or below participated in this study, accounting for 48.82%. Univariate analysis showed that gender, age, duration of medication, frequency of dupilumab use were risk factors for the occurrence of adverse effects (P < 0.05). Multivariate logistic regression analysis showed that age [odds ratio [OR]: 0.071, 95% confidence interval [CI]: 0.012-0.433; P = 0.004] and frequency of dupilumab use (OR: 3.306, 95% CI: 1.078-10.135; P = 0.036) were risk factors for adverse effects. The outcomes of ADRs were improved in 10 cases (15.38%) and completely recovered in 55 cases (84.62%).

Conclusion: Dupilumab has a good safety profile in Chinese children aged 6 months to 18 years for up to 2 years of treatment, with most adverse reactions being mild to moderate, and no serious ocular adverse reactions were reported. Age and frequency of dupilumab use were risk factors for adverse effects. Younger age and higher frequency of dupilumab use were associated with higher odds of ADRs.

Keywords: adverse drug reactions; children; dupilumab; real world; safety.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Distribution of time to occurrence of ADRs.
Figure 2
Figure 2
Distribution of time to occurrence of serious ADRs.
See this image and copyright information in PMC

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References

    1. Macdonald LE, Karow M, Stevens S, Auerbach W, Poueymirou WT, Yasenchak J. Precise and in situ genetic humanization of 6 mb of mouse immunoglobulin genes. Proc Natl Acad Sci U S A. (2014) 111:5147–52. 10.1073/pnas.1323896111 - DOI - PMC - PubMed
    1. Murphy AJ, Macdonald LE, Stevens S, Karow M, Dore AT, Pobursky K. Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice. Proc Natl Acad Sci U S A. (2014) 111:5153–8. 10.1073/pnas.1324022111 - DOI - PMC - PubMed
    1. Le Floc'h A, Allinne J, Nagashima K, Scott G, Birchard D, Asrat S. Dual blockade of IL-4 and IL-13 with dupilumab, an IL-4Rα antibody, is required to broadly inhibit type 2 inflammation. Allergy. (2020) 75(5):1188–204. 10.1111/all.14151 - DOI - PMC - PubMed
    1. Napolitano M, Maffei M, Patruno C, Leone CA, Di Guida A, Potestio L. Dupilumab effectiveness for the treatment of patients with concomitant atopic dermatitis and chronic rhinosinusitis with nasal polyposis. Dermatol Ther. (2021) 34(6):e15120. 10.1111/dth.15120 - DOI - PubMed
    1. Patruno C, Napolitano M, Argenziano G, Peris K, Ortoncelli M, Girolomoni G. Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study. J Eur Acad Dermatol Venereol. (2021) 35(4):958–64. 10.1111/jdv.17094 - DOI - PubMed

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