Omalizumab in the severe exacerbations of seasonal allergic rhinitis

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Abstract

BACKGROUND: According to the Federal Clinical Guidelines, patients with severe persistent allergic rhinitis and/or severe exacerbation who failed to respond to third-line pharmacotherapy (antihistamines, leukotriene receptor antagonists, nasal corticosteroids) are advised to consider the administration of omalizumab. However, there is a lack of practical recommendations guiding the regimens and duration of the omalizumab therapy in the severe exacerbation of seasonal allergic rhinitis.

AIMS: To assess the efficacy of omalizumab additional therapy in patients with severe exacerbation of allergic rhinitis during the pollen season, and to determine the optimal regimen and duration of treatment.

MATERIALS AND METHODS: This is an open observational uncontrolled prospective single-center study. 10 adult patients with severe exacerbation of seasonal allergic rhinitis due to birch pollen were selected for the study. All of them received the third-line of therapy according to Federal Clinical Guidelines and had absence or incomplete control: Total nasal symptom score ≥2. All of them were treated with omalizumab. The dose and regime were prescribed according to instructions that took into account the overall IgE level, as well as the patient’s weight. Daily symptom diaries and the need for rescue medication levels were evaluated. The primary endpoint had a decrease in the Combined Medical and Symptom Score mean.

RESULTS: The additional omalizumab treatment improved allergic rhinitis control for all patients and also reduced the rescue medication (ΔTNSS 1.8 [95% CI 1.56–2.04]; р <0.001, and ΔCMSS 2.12 [95% CI 1.74–2.5]; р <0.001, by the end of 1 week after the first omalizumab injection; ΔTNSS 2.53 [95% CI 2.05–3.01]; р <0.0001, and ΔCMSS 5.22 [95% CI 4.74–5.7]; р <0.001, by the end of four weeks, respectively). It was noted that the omalizumab effect realization occurs for some time (3–7 days). Due to short-season pollen for birch (1–2 months), the duration of treatment in our study did not exceed one month, so we managed to achieve complete control over the symptoms in all patients by the omalizumab with a small multiplicity of injections (1–2 injections). No adverse events were registered during the study.

CONCLUSION: Omalizumab additional therapy in patients with severe exacerbation of allergic rhinitis allows control of all symptoms. Taking into account the mechanism of its action, omalizumab should be administered at least a week before the expected pollen season in patients with severe exacerbation (according to the previous seasons) who did not complete their allergen-specific immunotherapy on time, and continue therapy till the end of the pollen season.

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About the authors

Ksenia S. Pavlova

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Author for correspondence.
Email: ksenimedical@gmail.com
ORCID iD: 0000-0002-4164-4094
SPIN-code: 7593-0838
Scopus Author ID: 7004658159
ResearcherId: P-9255-2017

MD, Cand. Sci. (Med.)

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

Darya S. Kulichenko

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Email: darya.mdinaradze@yandex.ru
ORCID iD: 0000-0002-7375-1759
SPIN-code: 2036-0430

младший научный сотрудник

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

Oksana M. Kurbacheva

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Email: kurbacheva@gmail.com
ORCID iD: 0000-0003-3250-0694
SPIN-code: 5698-6436

MD, Dr. Sci. (Med.), Professor

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

Miramgul E. Dyneva

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Email: amanturliva.miramgul@mail.ru
ORCID iD: 0000-0003-1965-8446
SPIN-code: 9504-0251
Scopus Author ID: 57214749322
ResearcherId: D-1943-2019

MD, Cand. Sci. (Med.)

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

Natalia I. Ilina

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Email: instimmun@yandex.ru
ORCID iD: 0000-0002-3556-969X
SPIN-code: 6715-5650

MD, Dr. Sci. (Med.), Professor

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

References

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  7. Holgate S, Casale T, Wenzel S, et al. The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol. 2005;115(3):459–465. doi: 10.1016/j.jaci.2004.11.053
  8. Beck LA, Marcotte GV, MacGlashan D, et al. Omalizumab-induced reductions in mast cell Fcepsilon RI expression and function. J Allergy Clin Immunol. 2004;114(3):527–530. doi: 10.1016/j.jaci.2004.06.032
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Supplementary files

Supplementary Files
Action
1. Fig. Change from baseline in Total nasal symptom score (TNSS), Medical score (MS), Combined medical and symptom score (СМSS) due to omalizumab treatment, n=10. Note: * Significantly different from baseline in CMSS due to omalizumab treatment; • ― significantly different from baseline in MS due to omalizumab treatment;  ― significantly different from baseline in TNSS due to omalizumab treatment. TNSS ― Total nasal symptom score; MS ― Medical score; CMSS ― Combined medical and symptom score. Data were described as Me [Q25%; Q75%] and Min–Max. The differences were considered statistically significant at p ≤0.05.

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