Real-World Study of Ragweed Sublingual Immunotherapy in Hungary
Main Article Content
Keywords
allergic rhinitis, immunotherapy safety, ragweed, real-life study, respiratory allergies, sublingual immunotherapy
Abstract
Background: Ragweed (Ambrosia elatior) has become invasive in Europe, causing significant respiratory issues. Subcutaneous allergen immunotherapy (SCIT) has long been used to manage pollen allergies, but sublingual immunotherapy (SLIT) has gained interest.
Objective: This study aimed to evaluate the clinical benefits of ragweed SLIT under real-world in a cohort of Hungarian patients allergic to ragweed pollen.
Methods: We retrospectively reviewed the clinical records of 57 patients during the 2015 and 2016 ragweed pollen seasons. Patients were divided into two groups: Group 1 (n = 29), who had not received immunotherapy, and Group 2 (n = 28), who had previously undergone immunotherapy with another sublingual preparation. All patients were treated with Oraltek® ragweed for 4–6 months, initiating 2–4 months before the pollen season and rest of the period was 2 months of the 2016 pollen season. Symptom score (SS), medication score (MS), and combined symptom and medication score (CSMS) were evaluated intra- and intergroup.
Results: Pollen counts were consistent between 2015 and 2016. All patients showed significant improvement in SS, MS, and CSMS, with a large effect size (>0.8). Group 2 had significantly lower SS and CSMS in 2015 because of prior immunotherapy. By 2016, both groups exhibited marked improvements, with Group 1 showing a 75% improvement in CSMS. No local or systemic reactions were recorded, indicating a high safety profile.
Conclusions: Ragweed SLIT significantly improved symptoms and reduced use of medication in patients allergic to ragweed pollen. The treatment was effective even in patients with previous immunotherapy, with a high benefit–risk ratio demonstrated by the absence of adverse reactions. These findings support the use of Oraltek SLIT for managing ragweed pollen allergy.
References
2. Oswalt ML, Marshall GD. Ragweed as an example of worldwide allergen expansion. Allergy Asthma Clin Immunol. 2008;4(3):130. https://doi.org.10.1186/1710-1492-4-3-130
3. Bousquet PJ, Burbach G, Heinzerling LM, Edenharter G, Bachert C, Bindslev-Jensen C, et al. GA2LEN skin test study III: Minimum battery of test inhalent allergens needed in epidemiological studies in patients. Allergy. 2009;64(11):1656–62. https://doi.org/10.1111/j.1398-9995.2009.02169.x
4. Ruëff F, Przybilla B, Walker A, Gmeiner J, Kramer M, Sabanés-Bové D, et al. Sensitization to common ragweed in Southern Bavaria: Clinical and geographical risk factors in atopic patients. Int Arch Allergy Immunol. 2012;159(1):65–74. https://doi.org/10.1159/000335192
5. Makra L, Matyasovszky I. Assessment of the daily ragweed pollen concentration with previous-day meteorological variables using regression and quantile regression analysis for Szeged, Hungary. Aerobiologia. 2011;27(3):247–59.
6. Clowes GHA. A preliminary communication on the treatment of autumnal hay fever by vaccination with an aqueous extract of the pollen of ragweed. Proc Soc Exp Biol Med. 1913;10(3):70–2. https://doi.org/10.3181/00379727-10-49
7. Canonica GW, Passalacqua G. Noninjection routes for immunotherapy. J Allergy Clin Immunol. 2003;111(3):437–48; quiz 449. https://doi.org/10.1067/mai.2003.129
8. Pfaar O, Klimek L, Gerth van Wijk R. Clinically relevant outcome measures for new pharmacotherapy, allergen avoidance and immunotherapy trials in allergic rhinoconjunctivitis. Curr Opin Allergy Clin Immunol. 2015;15(3):197–203. https://doi.org/10.1097/ACI.0000000000000164
9. Emberlin J. The effects of patterns in climate and pollen abundance on allergy. Allergy. 1994;49(18 Suppl):15–20. https://doi.org/10.1111/j.1398-9995.1994.tb04233.x
10. Banken R, Comtois P. Concentration of ragweed pollen and prevalence of allergic rhinitis in 2 municipalities in the Laurentides. Allergy Immunol (Paris). 1992;24(3):91–4.
11. Cohen J. Statistical power analysis for the behavioral sciences, 2nd ed. London: Academic Press; 1977.
12. Robbins T, Lim Choi Keung SN, Sankar S, Randeva H, Arvanitis TN. Application of standardised effect sizes to hospital discharge outcomes for people with diabetes. BMC Med Inform Decis Mak. 2020;20(1):150. https://doi.org/10.1186/s12911-020-01169-z
13. Sullivan GM, Feinn R. Using effect size-or why the P value is not enough. J Grad Med Edu. 2012;4(3):279–82. https://doi.org/10.4300/JGME-D-12-00156.1
14. Kim H, Waserman S, Hébert J, Blaiss M, Nelson H, Creticos P, et al. Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2014;10(1):55–55. https://doi.org/10.1186/1710-1492-10-55
15. Nolte H, Hébert J, Berman G, Gawchik S, White M, Kaur A, et al. Randomized controlled trial of ragweed allergy immunotherapy tablet efficacy and safety in North American adults. Ann Allergy Asthma Immunol. 2013;110(6):450–6.e4. https://doi.org/10.1016/j.anai.2013.03.013
16. Creticos PS, Maloney J, Bernstein DI, Casale T, Kaur A, Fisher R, et al. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013;131(5):1342–9.e6. https://doi.org/10.1016/j.jaci.2013.03.019
17. Skoner D, Gentile D, Bush R, Fasano MB, McLaughlin A, Esch RE. Sublingual immunotherapy in patients with allergic rhinoconjunctivitis caused by ragweed pollen. J Allergy Clin Immunol. 2010;125(3):660–6, 666.e1–e4. https://doi.org/10.1016/j.jaci.2009.12.931