Efficacy and predictors of rapid response to omalizumab therapy in patients with seasonal allergic rhinitis: a cohort study

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Abstract

BACKGROUND: The availability of anti-IgE therapy for allergic rhinitis has actualized the need to develop variants of this treatment according to predictors of rapid response and techniques of treatment initiation.

AIM: To study the efficacy and predictors of response to omalizumab in patients with seasonal allergic rhinitis.

MATERIALS AND METHODS: Patients with moderate or severe seasonal allergic rhinitis in which traditional treatment for at least 3 months was not effective in the previous pollen season or in the current season were included. The decision to prescribe omalizumab was made based on the visual analog scale (VAS) in the previous or current season. The dosage and frequency of administration (every 2 or 4 weeks) were determined according to the table of values provided in the instructions. The patients were observed for 2 months. At follow-up visits (1 and 2 months later), allergic rhinitis symptom control was assessed using VAS and total nasal symptoms score (TNSS). Therapy was considered effective when the VAS remained <30 or decreased ≥30 after 4 and 8 weeks from the start of therapy, depending on the initiation period.

RESULTS: The study enrolled 30 patients with allergic rhinitis history of 14 years, sensitization to ≥2 groups of allergens in 19 (63.3%) cases and bronchial asthma in 18 (60%). Omalizumab was initiated before the pollen season in 6 (20%) patients and during the season in 24 (80%) patients. After 4 weeks, allergic rhinitis manifestations were controlled in 23 (77%) patients, and by week 8, 100% of the patients with allergic rhinitis had fully responded to therapy. By 4 weeks of follow-up, the severity of allergic rhinitis symptoms on the VAS and TNSS scales decreased by 2.7 and 4.7 times, respectively. The proportion of patients with a slow response by week 4 of therapy was 23%. Body mass index (lower in the “slow” response group) and history of bronchial asthma (2.6 times longer in the “slow” responders) were associated with the achievement of this outcome. No adverse events were recorded.

CONCLUSIONS: In patients with seasonal allergic rhinitis, omalizumab allows the control of disease manifestations after 4 weeks of therapy with its maintenance in the follow-up. Predictors of rapid response have been revealed; however, their clinical significance requires further study.

About the authors

Daria S. Fomina

The First Sechenov Moscow State Medical University

Author for correspondence.
Email: daria_fomina@mail.ru
ORCID iD: 0000-0002-5083-6637

MD, Cand. Sci. (Med.), associate professor

Russian Federation, Moscow

Olga A. Mukhina

City Clinical Hospital No. 52

Email: mukhina.a.o@gmail.com
ORCID iD: 0000-0002-3794-4991

MD

Russian Federation, Moscow

Elena N. Bobrikova

City Clinical Hospital No. 52

Email: elena.bobrikova.69@mail.ru
ORCID iD: 0000-0002-6534-5902

MD

Russian Federation, Moscow

Marina S. Lebedkina

City Clinical Hospital No. 52

Email: mari-na.ivanova0808@yandex.ru
ORCID iD: 0000-0002-9545-4720

MD

Russian Federation, Moscow

Anton A. Chernov

City Clinical Hospital No. 52

Email: sbornay1med@yandex.ru
ORCID iD: 0000-0001-6209-387X

junior research associate

Russian Federation, Moscow

Mariana A. Lysenko

City Clinical Hospital No. 52

Email: gkb52@zdrav.mos.ru
ORCID iD: 0000-0001-6010-7975

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

Russian Federation, Moscow

References

  1. Ma T, Wang H, Wang X. Effectiveness and response predictors of omalizumab in treating patients with seasonal allergic rhinitis: А real-world study. J Asthma Allergy. 2021;14:59–66. doi: 10.2147/JAA.S288952
  2. Clinical recommendations “Allergic rhinitis” (approved by the Ministry of Health of Russia). 2020. (In Russ). Available from: https://legalacts.ru/doc/klinicheskie-rekomendatsii-allergicheskii-rinit-utv-minzdravom-rossii/. Accessed: 19.05.2022.
  3. Dyneva ME, Kurbacheva OM. Allergic rhinitis-an actual problem of the XXI century. Consilium medicum. 2019;21(3):65–68. (In Russ).
  4. Malone DC, Lawson KA, Smith DH, et al. A cost of illness study of allergic rhinitis in the United States. J Allergy Clin Immunol. 1997; 99(1 Pt 1):22–27. doi: 10.1016/s0091-6749(97)70296-3
  5. Kim SY, Yoon SJ, Jo MW, et al. Economic burden of allergic rhinitis in Korea. Am J Rhinol Allergy. 2010;24(5):e110–113. doi: 10.2500/ajra.2010.24.3513
  6. 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):332–340.e1. doi: 10.1016/j.jaip.2014.02.001
  7. Metz M, Vadasz Z, Kocatürk E, Giménez-Arnau AM. Omalizumab updosing in chronic spontaneous urticaria: An overview of real-world evidence. Clin Rev Allergy Immunol. 2020;59(1):38–45. doi: 10.1007/s12016-020-08794-6
  8. Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020;146(3):595–605. doi: 10.1016/j.jaci.2020.05.032
  9. Yu C, Wang K, Cui X, et al. Clinical efficacy and safety of omalizumab in the treatment of allergic rhinitis: A systematic review and meta-analysis of randomized clinical trials. Am J Rhinol Allergy. 2020;34(2):196–208. doi: 10.1177/1945892419884774
  10. Casale TB, Busse WW, Kline JN, et al. Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. J Allergy Clin Immunol. 2006; 117(2):134–140. doi: 10.1016/j.jaci.2005.09.036
  11. Hirano K, Suzaki I, Uruma S, et al. Impact of omalizumab on pollen-induced seasonal allergic rhinitis: An observational study in clinical practice. Int Forum Allergy Rhinol. 2021;11(11):1588–1591. doi: 10.1002/alr.22827
  12. Instructions for the use of the drug Omalizumab. (In Russ). Available from: https://grls.rosminzdrav.ru/. Accessed: 19.12.2022.
  13. Brożek JL, Bousquet J, Agache I, et al. Allergic rhinitis and its impact on asthma (ARIA) guidelines--2016 revision. J Allergy Clin Immunol. 2017;140(4):950–958. doi: 10.1016/j.jaci.2017.03.050
  14. Tamasauskiene L, Gasiuniene E, Sitkauskiene B. Translation, adaption and validation of the total nasal symptom score (TNSS) for Lithuanian population. Health Qual Life Outcomes. 2021;19(1):54. doi: 10.1186/s12955-020-01659-8
  15. Goryachkina LA, Peredkova EV, Khramtsova EV. Pollinoses. A textbook for doctors. Moscow; 2004. 24 р. (In Russ).
  16. Eschenbacher W, Straesser M, Knoeddler A, et al. Biologics for the treatment of allergic rhinitis, chronic rhinosinusitis, and nasal polyposis. Immunol Allergy Clin North Am. 2020;40(4):539–547. doi: 10.1016/j.iac.2020.06.001
  17. Zhang Y, Xi L, Gao Y, et al. Omalizumab is effective in the preseasonal treatment of seasonal allergic rhinitis. Clin Transl Allergy. 2022;12(1):e12094. doi: 10.1002/clt2.12094
  18. Adelroth E, Rak S, Haahtela T, et al. Recombinant humanized mAb-E25, an anti-IgE mAb, in birch polleninduced seasonal allergic rhinitis. J Allergy Clin Immunol. 2000;106(2):253–259. doi: 10.1067/mai.2000.108310
  19. Nagakura T, Ogino S, Okubo K, et al. Omalizumab is more effective than suplatast tosilate in the treatment of Japanese cedar pollen-induced seasonal allergic rhinitis. Clin Exp Allergy. 2008;38(2):329–337. doi: 10.1111/j.1365-2222.2007.02894.x
  20. Okubo K, Ogino S, Nagakura T, et al. Omalizumab is effective and safe in the treatment of Japanese cedar pollen-induced seasonal allergic rhinitis. Allergol Int. 2006;55(4):379–386. doi: 10.2332/allergolint.55.379
  21. Adachi M, Kozawa M, Yoshisue H, et al. Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: a long-term post-marketing study in Japan. Resp Med. 2018;141: 56–63. doi: 10.1016/j.rmed.2018.06.021
  22. Chervinsky P, Casale T, Townley R, et al. Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2003;91(2):160–167. doi: 10.1016/S1081-1206(10)62171-0
  23. Vignola AM, Humbert M, Bousquet J, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy. 2004;59(7):709–717. doi: 10.1111/j.1398-9995.2004.00550.x
  24. Fomina DS, Mukhina OA, Lebedkina MS, et al. Analysis of predictors of response to anti-IgE therapy in patients with severe atopic bronchial asthma in real clinical practice. Therapeutic Archive. 2022;94(3): 413–419. (In Russ). doi: 10.26442/00403660.2022.03.201437

Supplementary files

Supplementary Files
Action
1. JATS XML
2. Fig. 1. Variants of the combination of types of sensitization in patients with seasonal allergic rhinitis who received anti-IgE therapy with omalizumab.Note: Б ― household sensitization; Э ― epidermal sensitization; Г ― fungal sensitization; П ― pollen sensitization.

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Copyright (c) 2022 Fomina D.S., Mukhina O.A., Bobrikova E.N., Lebedkina M.S., Chernov A.A., Lysenko M.A.

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