{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T22:49:44Z","timestamp":1787870984747,"version":"build-2784847793"},"reference-count":38,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T00:00:00Z","timestamp":1738886400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JPM"],"abstract":"<jats:p>Background: Chronic spontaneous urticaria (CSU) and moderate-to-severe atopic dermatitis (AD) are significant challenges in pediatric populations, negatively impacting quality of life (QoL). Biologic therapies, including omalizumab and dupilumab, showed considerable promise for patients unresponsive to conventional treatments. This study evaluated the real-life efficacy and safety of these biologics in pediatric CSU and AD patients. Methods: A retrospective, monocentric study was conducted enrolling pediatric patients (aged 6\u201318 years) followed at the \u201cG. Martino\u201d Hospital, University of Messina. This study included patients with CSU unresponsive to antihistamines and those with moderate-to-severe AD refractory to topical therapies. Disease severity and treatment efficacy were evaluated using the Urticaria Activity Score 7 (UAS7) for CSU, the Eczema Area and Severity Index (EASI) for AD, and QoL metrics, including the Dermatology Life Quality Index (DLQI) and numerical rating scales, for pruritus (p-NRS) and sleep (s-NRS), at baseline, 16 weeks, and 52 weeks. Safety was assessed through the monitoring of reported adverse events (AEs). Results: Omalizumab significantly reduced UAS7 scores by 71.9% at 16 weeks and 75.3% at 52 weeks (p &lt; 0.001), with concurrent improvements in c-DLQI. Dupilumab reduced the EASI score by 75.3%, p-NRS by 40%, and s-NRS by 52.9% over 52 weeks, with c-DLQI improving by 72.6%. No severe AEs were observed; mild reactions included injection-site erythema and respiratory symptoms. Conclusions: Omalizumab and dupilumab demonstrated significant efficacy in reducing disease severity and improving QoL in pediatric patients with CSU and AD. Moreover, their safety profile underscores their potential as essential treatments for these conditions.<\/jats:p>","DOI":"10.3390\/jpm15020064","type":"journal-article","created":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T10:07:56Z","timestamp":1738922876000},"page":"64","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and Safety of Omalizumab and Dupilumab in Pediatric Patients with Skin Diseases: An Observational Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4166-2030","authenticated-orcid":false,"given":"Francesca","family":"Galletta","sequence":"first","affiliation":[{"name":"Pediatric Unit, Department of Human Pathology in Adult and Developmental Age \u201cGaetano Barresi\u201d, University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludovica","family":"Rizzuti","sequence":"additional","affiliation":[{"name":"Pediatric Unit, Department of Human Pathology in Adult and Developmental Age \u201cGaetano Barresi\u201d, University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4369-7798","authenticated-orcid":false,"given":"Stefano","family":"Passanisi","sequence":"additional","affiliation":[{"name":"Pediatric Unit, Department of Human Pathology in Adult and Developmental Age \u201cGaetano Barresi\u201d, University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuela","family":"Rosa","sequence":"additional","affiliation":[{"name":"Pediatric Unit, Department of Human Pathology in Adult and Developmental Age \u201cGaetano Barresi\u201d, University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucia","family":"Caminiti","sequence":"additional","affiliation":[{"name":"Pediatric Unit, Department of Human Pathology in Adult and Developmental Age \u201cGaetano Barresi\u201d, University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5420-8411","authenticated-orcid":false,"given":"Sara","family":"Manti","sequence":"additional","affiliation":[{"name":"Pediatric Unit, Department of Human Pathology in Adult and Developmental Age \u201cGaetano Barresi\u201d, University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,2,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"3659","DOI":"10.1111\/all.15089","article-title":"Advances and highlights in biomarkers of allergic diseases","volume":"76","author":"Ogulur","year":"2021","journal-title":"Allergy"},{"key":"ref_2","first-page":"140","article-title":"Biologics in Children with Allergic Diseases","volume":"16","author":"Licari","year":"2020","journal-title":"Curr. Pediatr. Rev."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1111\/all.14037","article-title":"Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis","volume":"75","author":"Fricke","year":"2020","journal-title":"Allergy"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"adv00160","DOI":"10.2340\/00015555-3510","article-title":"Prevalence and Incidence of Atopic Dermatitis: A Systematic Review","volume":"100","author":"Bylund","year":"2020","journal-title":"Acta Derm.-Venereol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1016\/j.jaci.2004.11.053","article-title":"The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation","volume":"115","author":"Holgate","year":"2005","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_6","unstructured":"(2025, January 02). Xolair (Omalizumab) Prescribing Information. Available online: https:\/\/www.gene.com\/download\/pdf\/xolair_prescribing.pdf."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1186\/s13052-019-0695-x","article-title":"Management of chronic urticaria in children: A clinical guideline","volume":"45","author":"Caffarelli","year":"2019","journal-title":"Ital. J. Pediatr."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1111\/cea.13491","article-title":"Mechanisms of Dupilumab","volume":"50","author":"Harb","year":"2020","journal-title":"Clin. Exp. Allergy"},{"key":"ref_9","unstructured":"(2025, January 02). Dupixent (Dupilumab) Prescribing Information. Available online: https:\/\/ec.europa.eu\/health\/documents\/community-register\/2021\/20210111150156\/anx_150156_it.pdf."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"e43","DOI":"10.1016\/j.jaad.2023.08.102","article-title":"Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies","volume":"90","author":"Davis","year":"2024","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1183\/20734735.001918","article-title":"How to obtain informed consent for research","volume":"14","author":"Manti","year":"2018","journal-title":"Breathe"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1185","DOI":"10.1016\/j.jaip.2017.10.001","article-title":"The Urticaria Activity Score-Validity, Reliability, and Responsiveness","volume":"6","author":"Hawro","year":"2018","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1034\/j.1600-0625.2001.100102.x","article-title":"The eczema area and severity index (EASI): Assessment of reliability in atopic dermatitis. EASI Evaluator Group","volume":"10","author":"Hanifin","year":"2001","journal-title":"Exp. Dermatol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1111\/bjd.20783","article-title":"Psychometric validation and responder definition of the sleep disturbance numerical rating scale in moderate-to-severe atopic dermatitis","volume":"186","author":"Puelles","year":"2022","journal-title":"Br. J. Dermatol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1186\/s41687-020-00265-y","article-title":"Content validity of a sleep numerical rating scale and a sleep diary in adults and adolescents with moderate-to-severe atopic dermatitis","volume":"4","author":"Matos","year":"2020","journal-title":"J. Patient-Rep. Outcomes"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1046\/j.1365-2133.2003.05157.x","article-title":"The Children\u2019s Dermatology Life Quality Index: Validation of the cartoon version","volume":"148","author":"Holme","year":"2003","journal-title":"Br. J. Dermatol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1111\/all.14547","article-title":"Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines","volume":"76","author":"Agache","year":"2021","journal-title":"Allergy"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"8202476","DOI":"10.1155\/2024\/8202476","article-title":"Temporal, Drug Dose, and Sample Size Trends in the Efficacy of Omalizumab for Chronic Spontaneous Urticaria: A Cumulative Meta-Analysis","volume":"2024","author":"Qin","year":"2024","journal-title":"J. Clin. Pharm. Ther."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1001\/jamadermatol.2018.3447","article-title":"Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients with Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of \u201cReal-world\u201d Evidence","volume":"155","author":"Tharp","year":"2019","journal-title":"JAMA Dermatol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/j.jdermsci.2017.03.009","article-title":"Efficacy and safety of omal- izumab in Japanese and Korean patients with refractory chronic spontaneous urticaria","volume":"87","author":"Hide","year":"2017","journal-title":"J. Dermatol. Sci."},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Caminiti, L., Galletta, F., Foti Randazzese, S., Barraco, P., Passanisi, S., Gambadauro, A., Crisafulli, G., Valenzise, M., and Manti, S. (2024). Early Assessment of Efficacy and Safety of Biologics in Pediatric Allergic Diseases: Preliminary Results from a Prospective Real-World Study. Children, 11.","DOI":"10.3390\/children11020170"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"e13489","DOI":"10.1111\/dth.13489","article-title":"Omalizumab in children and adolescents with chronic spontaneous urticaria: Case series and review of the literature","volume":"33","author":"Passanisi","year":"2020","journal-title":"Dermatol. Ther."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"2487","DOI":"10.1016\/j.jaip.2019.04.020","article-title":"Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU)","volume":"7","author":"Casale","year":"2019","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"36","DOI":"10.2174\/1573398X13666170426094536","article-title":"Omalizumab in Childhood Asthma Italian Study Group. Omalizumab in Children with Severe Allergic Asthma: The Italian Real-Life Experience","volume":"13","author":"Licari","year":"2017","journal-title":"Curr. Respir. Med. Rev."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1111\/j.1398-9995.2004.00533.x","article-title":"Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma","volume":"59","author":"Ayres","year":"2004","journal-title":"Allergy"},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Galletta, F., Caminiti, L., Lugar\u00e0, C., Foti Randazzese, S., Barraco, P., D\u2019Amico, F., Irrera, P., Crisafulli, G., and Manti, S. (2023). Long-Term Safety of Omalizumab in Children with Asthma and\/or Chronic Spontaneous Urticaria: A 4-Year Prospective Study in Real Life. J. Pers. Med., 13.","DOI":"10.3390\/jpm13071068"},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Calzari, P., Chiei Gallo, A., Barei, F., Bono, E., Cugno, M., Marzano, A.V., and Ferrucci, S.M. (2024). Omalizumab for the Treatment of Chronic Spontaneous Urticaria in Adults and Adolescents: An Eight-Year Real-Life Experience. J. Clin. Med., 13.","DOI":"10.3390\/jcm13185610"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1007\/s40257-022-00683-2","article-title":"Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE)","volume":"23","author":"Blauvelt","year":"2022","journal-title":"Am. J. Clin. Dermatol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1282","DOI":"10.1016\/j.jaad.2020.06.054","article-title":"Efficacy and Safety of Dupilumab with Concomitant Topical Corticosteroids in Children 6 to 11 Years Old with Severe Atopic Dermatitis: A Randomized, Double-Blinded, Placebo-Controlled Phase 3 Trial","volume":"83","author":"Paller","year":"2020","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"2378","DOI":"10.1016\/j.jaip.2022.06.014","article-title":"Dupilumab Improves Clinical Scores in Children and Adolescents with Moderate to Severe Atopic Dermatitis: A Real-World, Single-Center Study","volume":"10","author":"Pagan","year":"2022","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"578","DOI":"10.1093\/ced\/llae013","article-title":"Real-World Outcomes of Children Treated with Dupilumab for Moderate-to-Severe Atopic Dermatitis: A Single-Center Retrospective Observational UK Study","volume":"49","author":"Clayton","year":"2024","journal-title":"Clin. Exp. Dermatol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"2246602","DOI":"10.1080\/09546634.2023.2246602","article-title":"A 52-Week Multicenter Retrospective Real-World Study on Effectiveness and Safety of Dupilumab in Children with Atopic Dermatitis Aged 6 to 11 Years","volume":"34","author":"Patruno","year":"2023","journal-title":"J. Dermatol. Treat."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1007\/s40272-022-00531-0","article-title":"Dupilumab Treatment in Children Aged 6\u201311 Years with Atopic Dermatitis: A Multicentre, Real-Life Study","volume":"24","author":"Napolitano","year":"2022","journal-title":"Paediatr. Drugs"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2335","DOI":"10.1056\/NEJMoa1610020","article-title":"Two phase 3 trials of dupilumab versus placebo in atopic dermatitis","volume":"375","author":"Simpson","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1001\/jamadermatol.2019.3336","article-title":"Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: A phase 3 randomized clinical trial","volume":"156","author":"Simpson","year":"2019","journal-title":"JAMA Dermatol."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/j.jaad.2019.07.074","article-title":"Dupilumab shows long-term safety and efficacy in moderate-to-severe atopic dermatitis patients enrolled in a phase 3 open- label extension study","volume":"82","author":"Deleuran","year":"2019","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"e15415","DOI":"10.1111\/dth.15415","article-title":"Long-term real-world experience of the side effects of dupilumab in 128 patients with atopic dermatitis and related conditions aged 6 years and above: Retrospective chart analysis from a single tertiary care center","volume":"35","author":"Parmar","year":"2022","journal-title":"Dermatol. Ther."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"908","DOI":"10.1016\/S0140-6736(22)01539-2","article-title":"Dupilumab in Children Aged 6 Months to Younger than 6 Years with Uncontrolled Atopic Dermatitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial","volume":"400","author":"Paller","year":"2022","journal-title":"Lancet"}],"container-title":["Journal of Personalized Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4426\/15\/2\/64\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:28:53Z","timestamp":1760027333000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4426\/15\/2\/64"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,7]]},"references-count":38,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2025,2]]}},"alternative-id":["jpm15020064"],"URL":"https:\/\/doi.org\/10.3390\/jpm15020064","relation":{},"ISSN":["2075-4426"],"issn-type":[{"value":"2075-4426","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,7]]}}}