Long-Term Safety of Omalizumab in Children with Asthma and/or Chronic Spontaneous Urticaria: A 4-Year Prospective Study in Real Life

Background: Insufficient data are available on the long-term “real-life” safety profile of omalizumab in children. This study evaluated a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). Methods: A monocentric, prospective patients aged 6–18 years. Each patient completed standardized MedDRA questionnaire to identify adverse events (AEs). Results: In total, 23 patients, median age 15 (14–18) years, affected by (60.8%) CSU (39.2%), treated for 2 (1–4) years were enrolled. The most common AEs belong system organ class (SOC) general disorders and administration-site conditions (37.17%). Skin subcutaneous tissue problems represent second frequently reported (24.35%). Central nervous musculoskeletal quite frequent (15.38% 8.97%, respectively). Other tachycardia (5.12%), vertigo abdominal pain (2.60% 3.86%, respectively), dry eye (1.3%). Only one herpes virus infection during treatment No cases anaphylaxis, hemopathies, uronephropathies, respiratory, psychiatric, hepatobiliary, oncological pathologies reported. Conclusions: Long-term children appears well tolerated. Its efficacy makes an excellent alternative