PMID- 37511681
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230801
IS  - 2075-4426 (Print)
IS  - 2075-4426 (Electronic)
IS  - 2075-4426 (Linking)
VI  - 13
IP  - 7
DP  - 2023 Jun 29
TI  - Long-Term Safety of Omalizumab in Children with Asthma and/or Chronic Spontaneous 
      Urticaria: A 4-Year Prospective Study in Real Life.
LID - 10.3390/jpm13071068 [doi]
LID - 1068
AB  - 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.
FAU - Galletta, Francesca
AU  - Galletta F
AUID- ORCID: 0000-0002-4166-2030
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - Caminiti, Lucia
AU  - Caminiti L
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - Lugara, Cecilia
AU  - Lugara C
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - Foti Randazzese, Simone
AU  - Foti Randazzese S
AUID- ORCID: 0000-0001-7084-5605
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - Barraco, Paolo
AU  - Barraco P
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - D'Amico, Federica
AU  - D'Amico F
AUID- ORCID: 0009-0007-3802-0102
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - Irrera, Pierangela
AU  - Irrera P
AD  - Department of Clinical and Experimental Medicine, University of Messina, 98124 
      Messina, Italy.
FAU - Crisafulli, Giuseppe
AU  - Crisafulli G
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
FAU - Manti, Sara
AU  - Manti S
AUID- ORCID: 0000-0002-7664-3083
AD  - Pediatric Unit, Department of Human Pathology in Adult and Developmental Age 
      "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
LA  - eng
PT  - Journal Article
DEP - 20230629
PL  - Switzerland
TA  - J Pers Med
JT  - Journal of personalized medicine
JID - 101602269
PMC - PMC10381149
OTO - NOTNLM
OT  - asthma
OT  - children
OT  - chronic spontaneous urticaria
OT  - omalizumab
OT  - real-life study
OT  - safety
COIS- The authors declare no conflict of interest.
EDAT- 2023/07/29 11:47
MHDA- 2023/07/29 11:48
PMCR- 2023/06/29
CRDT- 2023/07/29 01:25
PHST- 2023/06/11 00:00 [received]
PHST- 2023/06/24 00:00 [revised]
PHST- 2023/06/26 00:00 [accepted]
PHST- 2023/07/29 11:48 [medline]
PHST- 2023/07/29 11:47 [pubmed]
PHST- 2023/07/29 01:25 [entrez]
PHST- 2023/06/29 00:00 [pmc-release]
AID - jpm13071068 [pii]
AID - jpm-13-01068 [pii]
AID - 10.3390/jpm13071068 [doi]
PST - epublish
SO  - J Pers Med. 2023 Jun 29;13(7):1068. doi: 10.3390/jpm13071068.