PMID- 34943337
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211228
IS  - 2227-9067 (Print)
IS  - 2227-9067 (Electronic)
IS  - 2227-9067 (Linking)
VI  - 8
IP  - 12
DP  - 2021 Dec 6
TI  - Clinical Experience with Anti-IgE Monoclonal Antibody (Omalizumab) in Pediatric 
      Severe Allergic Asthma-A Romanian Perspective.
LID - 10.3390/children8121141 [doi]
LID - 1141
AB  - BACKGROUND: Asthma is the most common chronic disease affecting children, with a 
      negative impact on their quality of life. Asthma is often associated with 
      comorbid allergic diseases, and its severity may be modulated by immunoglobulin E 
      (IgE)-mediated allergen sensitization. Omalizumab is a humanized monoclonal 
      anti-IgE antibody, the first biological therapy approved to treat patients aged 
      >/=6 years with severe allergic asthma. The primary objective of our study was to 
      investigate the efficacy and safety of Omalizumab in Romanian children with 
      severe allergic asthma. METHODS: In this observational real-life study, 12 
      children and adolescents aged 6 to 18 years (mean 12.4 years) with severe 
      allergic asthma received Omalizumab as an add-on treatment. Asthma control, 
      exacerbations, lung function, and adverse events were evaluated at baseline and 
      after the first year of treatment. RESULTS: We observed general improvement in 
      total asthma symptom scores and reduction in the rate of exacerbation of severe 
      asthma. Omalizumab treatment was associated with improvement in the measures of 
      lung function, and no serious adverse reactions were reported. FEV1 improved 
      significantly after one year of treatment with Omalizumab [DeltaFEV1 (% pred.) = 
      18.3], and [similarly, DeltaMEF50 (%) = 25.8]. The mean severe exacerbation rate of 
      asthma decreased from 4.1 +/- 2.8 to 1.15 +/- 0.78 (p < 0.0001) during the year of 
      treatment with Omalizumab. CONCLUSIONS: This study showed that Omalizumab can be 
      an effective and safe therapeutic option for Romanian children and adolescents 
      with severe allergic asthma, providing clinically relevant information on asthma 
      control and exacerbation rate in children and adolescents. The results 
      demonstrated the positive effect of Omalizumab in young patients with asthma, 
      starting from the first year of treatment.
FAU - Berghea, Elena Camelia
AU  - Berghea EC
AUID- ORCID: 0000-0001-9522-8363
AD  - Department of Pediatrics, Carol Davila University of Medicine and Pharmacy, 
      020021 Bucharest, Romania.
AD  - Department of Pediatrics, "Marie S. Curie" Emergency Children's Clinical 
      Hospital, 041451 Bucharest, Romania.
FAU - Balgradean, Mihaela
AU  - Balgradean M
AUID- ORCID: 0000-0003-3188-0330
AD  - Department of Pediatrics, Carol Davila University of Medicine and Pharmacy, 
      020021 Bucharest, Romania.
AD  - Department of Pediatrics, "Marie S. Curie" Emergency Children's Clinical 
      Hospital, 041451 Bucharest, Romania.
FAU - Pavelescu, Carmen
AU  - Pavelescu C
AUID- ORCID: 0000-0003-4547-3023
AD  - Department of Pediatrics, "Marie S. Curie" Emergency Children's Clinical 
      Hospital, 041451 Bucharest, Romania.
FAU - Cirstoveanu, Catalin Gabriel
AU  - Cirstoveanu CG
AUID- ORCID: 0000-0002-7778-0477
AD  - Department of Pediatrics, Carol Davila University of Medicine and Pharmacy, 
      020021 Bucharest, Romania.
AD  - Department of Pediatrics, "Marie S. Curie" Emergency Children's Clinical 
      Hospital, 041451 Bucharest, Romania.
FAU - Toma, Claudia Lucia
AU  - Toma CL
AD  - Department of Pediatrics, Carol Davila University of Medicine and Pharmacy, 
      020021 Bucharest, Romania.
AD  - Pneumology Department, "Marius Nasta" Institute of Pneumology, 050159 Bucharest, 
      Romania.
FAU - Ionescu, Marcela Daniela
AU  - Ionescu MD
AD  - Department of Pediatrics, Carol Davila University of Medicine and Pharmacy, 
      020021 Bucharest, Romania.
AD  - Department of Pediatrics, "Marie S. Curie" Emergency Children's Clinical 
      Hospital, 041451 Bucharest, Romania.
FAU - Bumbacea, Roxana Silvia
AU  - Bumbacea RS
AD  - Department of Pediatrics, Carol Davila University of Medicine and Pharmacy, 
      020021 Bucharest, Romania.
AD  - Allergology Department, "Dr Carol Davila" Nephrology Clinical Hospital, 010731 
      Bucharest, Romania.
LA  - eng
PT  - Journal Article
DEP - 20211206
PL  - Switzerland
TA  - Children (Basel)
JT  - Children (Basel, Switzerland)
JID - 101648936
PMC - PMC8700741
OTO - NOTNLM
OT  - Omalizumab
OT  - allergic asthma
OT  - anti-IgE
OT  - children
OT  - observational study
COIS- The authors E.C.B., M.D.I., and R.S.B. have received lecture and meeting fees 
      from Novartis. E.C.B. has received consultancy/advisory board fees and grants 
      from Novartis. The other authors declare no potential conflict of interest.
EDAT- 2021/12/25 06:00
MHDA- 2021/12/25 06:01
PMCR- 2021/12/06
CRDT- 2021/12/24 01:02
PHST- 2021/10/08 00:00 [received]
PHST- 2021/12/01 00:00 [revised]
PHST- 2021/12/01 00:00 [accepted]
PHST- 2021/12/24 01:02 [entrez]
PHST- 2021/12/25 06:00 [pubmed]
PHST- 2021/12/25 06:01 [medline]
PHST- 2021/12/06 00:00 [pmc-release]
AID - children8121141 [pii]
AID - children-08-01141 [pii]
AID - 10.3390/children8121141 [doi]
PST - epublish
SO  - Children (Basel). 2021 Dec 6;8(12):1141. doi: 10.3390/children8121141.