Affiliation:
1. Pediatric Unit, Department of Human Pathology in Adult and Developmental Age “Gaetano Barresi”, University of Messina, 98124 Messina, Italy
2. Department of Clinical and Experimental Medicine, University of Messina, 98124 Messina, Italy
Abstract
Background: Insufficient data are available on the long-term “real-life” safety profile of omalizumab in children. This study evaluated the long-term safety of omalizumab in a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). Methods: A monocentric, prospective study evaluated the long-term safety of omalizumab in patients aged 6–18 years. Each patient completed the standardized MedDRA questionnaire to identify adverse events (AEs). Results: In total, 23 patients, median age 15 (14–18) years, affected by severe asthma (60.8%) or CSU (39.2%), treated with omalizumab for 2 (1–4) years were enrolled. The most common AEs belong to the system organ class (SOC) of general disorders and administration-site conditions (37.17%). Skin and subcutaneous tissue problems represent the second most frequently reported AEs (24.35%). Central nervous system and musculoskeletal disorders were quite frequent (15.38% and 8.97%, respectively). Other adverse events were tachycardia (5.12%), vertigo and abdominal pain (2.60% and 3.86%, respectively), and dry eye (1.3%). Only one patient reported herpes virus infection during treatment (1.3%). No cases of anaphylaxis, hemopathies, uronephropathies, respiratory, psychiatric, hepatobiliary, or oncological pathologies were reported. Conclusions: Long-term “real-life” treatment with omalizumab in children appears well tolerated. Its safety and efficacy profile makes omalizumab an excellent alternative in severe asthma and CSU in children.
Reference55 articles.
1. Roles of omalizumab in various allergic diseases;Okayama;Allergol. Int.,2020
2. Genentech Inc (2023, June 01). Xolair: FDA Prescribing Information. Revised December. Available online: https://www.gene.com/download/pdf/xolair_prescribing.pdf.
3. Biologics in food allergy: Up-to-date;Passanisi;Expert Opin. Biol. Ther.,2021
4. (2014, March 31). Food and Drug Administration, Available online: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf.
5. Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: A systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma;Henriksen;Allergy Asthma Clin. Immunol.,2020
Cited by
9 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献