Efficacy of omalizumab in the management of moderate-to-severe asthma in paediatric patients: a clinical evaluation

Authors

  • Chukka Yamini Department of Pediatrics, Osmania Medical College, Hyderabad, Telangana, India
  • Harshini Malisetty Government Medical College, Mahbubnagar, Telangana, India
  • Sriramoju Vidyadhari Mamata Academy of Medical Sciences, Bachupally, Hyderabad, Telangana, India
  • Naveen Kudikala Department of Pediatrics, Gandhi Medical College, Secunderabad, Telangana, India
  • Sindhuja Kathuroju Government Medical College, Mahbubnagar, Telangana, India
  • Rishika Ammika Government Medical College, Mahbubnagar, Telangana, India

DOI:

https://doi.org/10.18203/2320-6012.ijrms20260230

Keywords:

Omalizumab, Allergic asthma, Chronic sinusitis, Pediatric allergy, Quality of life, Biologic therapy

Abstract

Background: Children diagnosed to have mild-to-intense allergic asthma (AA) often present with comorbid chronic sinusitis (CS), which complicates the management of their condition and adversely affects their quality of life (QoL). Omalizumab (OM), a monoclonal antibody (MCA) targeting IgE, has demonstrated potential in the management of both conditions; however, the availability of real-world data in pediatric populations is still restricted.

Methods: This study involved children having mild-to-intense AA and chronic rhinosinusitis, recruited from the Pediatric Allergy and Pulmonology Clinic at Indira Gandhi Institute of Child Health, Bengaluru, India. Omalizumab was administered from January 2021 to May 2023, subcutaneously every 2-4 weeks at doses of 150-600 mg based on body mass index and baseline IgE levels. Asthma control was gauged using the Childhood Asthma Control Test (C-ACT), Asthma Control Test (ACT), fractional exhaled nitric oxide (FeNO), and lung function (LF) indices.

Results: Omalizumab treatment significantly improved asthma control, shown by increased C-ACT/ACT scores (p<0.05) and a notable drop in FeNO levels (p<0.05). LF indices associated with small airway function (PEF%pred, FEF75%, FEF50%, FEF25–75%) demonstrated noteworthy improvement (p<0.05), whereas changes in FEV1%pred and FEV1/FVC were not statistically significant. VAS scores for CS symptoms significantly decreased (p<0.05).

Conclusions: Omalizumab effectively treats children having mild-to-intense AA and CS, enhancing asthma control, small airway function, and alleviating sinusitis symptoms. These findings endorse omalizumab as an additional therapy for this difficult pediatric group.

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References

Yan M, Meiling J. Research progress of anti-IgE monoclonal antibody omalizumab in the treatment of asthma. Shanghai Med Pharm J. 2014;35:12-5.

Xiang L, Zhao J, Zheng Y, Liu H, Hong J, Bao Y, et al. Uncontrolled asthma and its risk factors in Chinese children: a cross-sectional observational study. J Asthma. 2016;53(7):699-706. DOI: https://doi.org/10.3109/02770903.2016.1144199

Huang E, Ong PY. Severe atopic dermatitis in children. Curr Allergy Asthma Rep. 2018;18(6):35. DOI: https://doi.org/10.1007/s11882-018-0788-4

Tsabouri S, Tseretopoulou X, Priftis K, Ntzani EE. Omalizumab for the treatment of inadequately controlled allergic rhinitis: a systematic review and meta-analysis of randomized clinical trials. J Allergy Clin Immunol Pract. 2014;2(3):332-40.e1. DOI: https://doi.org/10.1016/j.jaip.2014.02.001

Davidson WF, Leung D, Beck LA, Berin CM, Boguniewicz M, Busse WW, et al. Report from the national institute of allergy and infectious diseases workshop on “atopic dermatitis and the atopic march: mechanisms and interventions”. J Allergy Clin Immunol. 2019;143(3):894-913. DOI: https://doi.org/10.1016/j.jaci.2019.01.003

Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, et al. The EAACI/GA(2) LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69(7):868-87. DOI: https://doi.org/10.1111/all.12313

China National Clinical Research Center for Respiratory Diseases, Cooperative Group of Asthma, The Subspecialty Group of Respiratory, The Society of Pediatrics, Chinese Medical Association, China Medicine Education Association Committee on Pediatrics. Expert consensus on the clinical application of omalizumab in children with allergic asthma. Chin J Appl Clin Pediatr. 2021;36:881-90.

Licari A, Marseglia G, Castagnoli R, Marseglia A, Ciprandi G. The discovery and development of omalizumab for the treatment of asthma. Expert Opin Drug Discov. 2015;10(9):1033-42. DOI: https://doi.org/10.1517/17460441.2015.1048220

Henriksen DP, Bodtger U, Sidenius K, Maltbaek N, Pedersen L, Madsen H, et al. Efficacy of omalizumab in children, adolescents, and adults with intense allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of intense asthma. Allergy Asthma Clin Immunol. 2020;16(1):49. DOI: https://doi.org/10.1186/s13223-020-00442-0

Hongyu J, Juan L, Wenfeng H, Jinhua G, Lin Z, Haibo Z. Systematic evaluation of efficacy and safety of omalizumab in the treatment of moderate to intense allergic asthma in children. Eval Anal Drug Use Hosp China. 2021;21:1091-6.

Yaqin W, Pengli F, Pin L, Boya C, Kun L, Peizhi M. Systematic evaluation of omalizumab in the treatment of allergic asthma in children and adolescents. Chin J Drug Eval. 2021;38:111-4.

Just J, Thonnelier C, Bourgoin-Heck M, Mala L, Molimard M, Humbert M. Omalizumab effectiveness in intense allergic asthma with multiple allergic comorbidities: a post-hoc analysis of the STELLAIR study. J Asthma Allergy. 2021;14:1129-38. DOI: https://doi.org/10.2147/JAA.S310888

Kim J, Kim BE, Lee J, Han Y, Jun HY, Kim H, et al. Epidermal thymic stromal lymphopoietin predicts the development of atopic dermatitis during infancy. J Allergy Clin Immunol. 2016;137(4):1282-1285.e4. DOI: https://doi.org/10.1016/j.jaci.2015.12.1306

Humbert M, Bousquet J, Bachert C, Palomares O, Pfister P, Kottakis I, et al. IgE-mediated multimorbidities in allergic asthma and the potential for omalizumab therapy. J Allergy Clin Immunol Pract. 2019;7(5):1418-29. DOI: https://doi.org/10.1016/j.jaip.2019.02.030

Gur CP, Sahiner UM. Childhood atopic dermatitis: current developments, treatment approaches, and future expectations. Turk J Med Sci. 2019;49(4):963-84. DOI: https://doi.org/10.3906/sag-1810-105

Kopp MV. Omalizumab: anti-IgE therapy in allergy. Curr Allergy Asthma Rep. 2011;11(2):101-6. DOI: https://doi.org/10.1007/s11882-010-0173-4

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Published

2026-01-30

How to Cite

Yamini, C., Malisetty, H., Vidyadhari, S., Kudikala, N., Kathuroju, S., & Ammika, R. (2026). Efficacy of omalizumab in the management of moderate-to-severe asthma in paediatric patients: a clinical evaluation. International Journal of Research in Medical Sciences, 14(2), 483–487. https://doi.org/10.18203/2320-6012.ijrms20260230

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Original Research Articles