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Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study

Abstract

Introduction

Intra-seasonal start of treatment with the SQ® grass sublingual immunotherapy (SLIT) tablet (GRAZAX®, ALK, Denmark) has been previously demonstrated to be well-tolerated. The objective of our study was to investigate the tolerability of intra-seasonal start of treatment comparing patients treated by allergists and general practitioners experienced in treatment of allergy (GPs).

Methods

In a non-interventional, open-label, observational study, data on intra-seasonal start with the SQ® grass SLIT tablet were recorded in patients treated by allergists and GPs in Germany. Adverse events (AEs) were recorded by the physicians at first administration and during the 1–3-month observation period. The tablets taken and any AEs were recorded by the patients in diaries for the first 14 days.

Results

Treatment with the SQ® grass SLIT tablet was started in 198 patients, and in 179 intra-seasonal (allergists: 140, GPs: 39) and 19 post-seasonal; average treatment period was 47 days. AEs related to intra-seasonal start were reported in 43.6% of patients; no relevant differences between allergists and GPs were observed. In the subgroup of GPs, patients were younger (p = 0.0191), had more frequently asthma (p = 0.0043), more patients used symptomatic medication in the previous pollen season (p = 0.0198) and were more frequently treated for other diseases (p = 0.0467). In the allergists subgroup, more diagnostic allergy tests were applied (p < 0.0001) with less anti-allergic premedication at first administration (p = 0.0026).

Conclusion

The intra-seasonal start of treatment with the SQ® grass SLIT tablet in patients routinely treated by allergists or GPs with experience in treatment of allergy was well-tolerated, although patient characteristics were different with respect to age, frequency of asthma and concomitant allergies, use of symptomatic medication in the previous grass pollen season and concomitant treatment of other diseases. The safety profile from a previous placebo-controlled clinical trial and data from a previous real-life study on intra-seasonal start performed by allergists were confirmed.

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References

  1. 1.

    Bousquet J, Khaltaev N, Cruz AA, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63(86):8–160.

    Article  Google Scholar 

  2. 2.

    Eifan AO, Shamji MH, Durham SR. Long-term clinical and immunological effects of allergen immunotherapy. Curr Opin Allergy Clin Immunol. 2011;11:586–93.

    CAS  Article  Google Scholar 

  3. 3.

    Creticos PS, Bernstein DI, Casale TB, Lockey RF, Maloney J, Nolte H. Coseasonal initiation of allergen immunotherapy: a systematic review. J Allergy Clin Immunol Pract. 2016;4(1194–1204):e4.

    Google Scholar 

  4. 4.

    Malling H-J, Lund L, Ipsen H, Poulsen LK. Safety and immunological changes during specific sublingual immunotherapy with SQ standardized grass allergen tablets. J Investig Allergol Clin Immunol. 2006;16:162–8.

    CAS  PubMed  Google Scholar 

  5. 5.

    Kleine-Tebbe J, Ribel M, Herold DA. Safety of a SQ-standardised grass allergen tablet for sublingual immunotherapy: a randomized, placebo-controlled trial. Allergy. 2006;61:181–4.

    CAS  Article  Google Scholar 

  6. 6.

    Calderon M, Essendrop M. Specific immunotherapy with high dose SQ standardised grass allergen tablets was safe and well tolerated. J Investig Allergol Clin Immunol. 2006;16:338–44.

    CAS  PubMed  Google Scholar 

  7. 7.

    Ibañez MD, Kaiser F, Knecht R, Armentia A, Schöpfer H, Tholstrup B, Bufe A. Safety of specific sublingual immunotherapy with SQ standardized grass allergen tablets in children. Pediatr Allergy Immunol. 2007;18:516–22.

    Article  Google Scholar 

  8. 8.

    Durham SR, Yang WH, Pedersen MR, Johansen N, Rak S. Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006;117:802–9.

    CAS  Article  Google Scholar 

  9. 9.

    Dahl R, Kapp A, Colombo G, de Monchy J, Rak S, Emminger W, Fernández Rivas M, Ribel M, Durham SR. Efficacy and safety of sublingual immunotherapy with grass allergen tablet for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006;118:434–40.

    CAS  Article  Google Scholar 

  10. 10.

    Dahl R, Stender A, Rak S. Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis. Allergy. 2006;61:185–90.

    CAS  Article  Google Scholar 

  11. 11.

    Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weißhaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009;23:167–73.

    Article  Google Scholar 

  12. 12.

    Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Riis B, Grønager PM, Durham SR. Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol. 2008;121:512–8.

    CAS  Article  Google Scholar 

  13. 13.

    Durham SR, Emminger W, Kapp A, Colombo G, de Monchy JGR, Rak S, Scadding GK, Andersen JS, Riis B, Dahl R. Long-term clinical efficacy in grass pollen-induced rhinoconjunctivitis after treatment with SQ-standardized grass allergy immunotherapy tablet. J Allergy Clin Immunol. 2010;125:131–8.

    CAS  Article  Google Scholar 

  14. 14.

    Durham SR, Emminger W, Kapp A, de Monchy JGR, Rak S, Scadding GK, Wurtzen PA, Andersen JS, Tholstrup B, Riis B, Dahl R. SQ-standardized sublingual grass immunotherapy: confirmation of disease modification 2 years after 3 years of treatment in a randomized trial. J Allergy Clin Immunol. 2012;129:717–25.

    Article  Google Scholar 

  15. 15.

    Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol. 2011;127:64–7.

    CAS  Article  Google Scholar 

  16. 16.

    Nelson HS, Nolte H, Creticos P, Maloney J, Wu J, Bernstein DI. Efficacy and safety of timothy grass allergy immunotherapy tablet in North American adults. J Allergy Clin Immunol. 2011;127:72–80.

    CAS  Article  Google Scholar 

  17. 17.

    Maloney J, Bernstein DI, Nelson H, Creticos P, Hébert J, Noonan M, Skoner D, Zhou Y, Kaur A, Nolte H. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014;112:146–53.

    CAS  Article  Google Scholar 

  18. 18.

    Reich K, Gessner C, Kroker A, Schwab JA, Pohl W, Villesen H, Wüstenberg E, Emminger W. Immunologic effects and tolerability profile of in-season initiation of a standardized-quality grass allergy immunotherapy tablet: a phase III, multicenter, randomized, double-blind, placebo-controlled trial in adults with grass pollen-induced rhinoconjunctivitis. Clin Ther. 2011;33:828–40.

    CAS  Article  Google Scholar 

  19. 19.

    Schwab JA, Wolf H, Schnitker J, Wüstenberg E. Safety and tolerability of an intra-seasonal initiation of the SQ-standardised grass allergy immunotherapy tablet: a non-interventional observational study investigating the feasibility during routine administration. Clin Drug Investig. 2013;33:719–26.

    CAS  Article  Google Scholar 

  20. 20.

    Gronke C, Wolf H, Schnitker J, Wüstenberg E. Treatment with the SQ-standardised grass allergy immunotherapy tablet is well tolerated in children, adolescents and adults in real life application—a non-interventional observational study. J Allergy Ther. 2013;4:146. https://doi.org/10.4172/2155-6121.1000146.

    Google Scholar 

  21. 21.

    Vitzthum HG, Wolf H, Schnitker J, Wüstenberg E. Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in adult patients during routine administration—a non-interventional observational study. J Allergy Ther. 2014;5:198. https://doi.org/10.4172/2155-6121.1000198.

    Google Scholar 

  22. 22.

    Horn A, Zeuner H, Wolf H, Schnitker J, Wüstenberg E. Health-related quality of life during routine treatment with the SQ-standardised grass allergy immunotherapy tablet: a non-interventional observational study. Clin Drug Investig. 2016;36:453–62.

    CAS  Article  Google Scholar 

  23. 23.

    Schmitt J, Schwarz K, Stadler E, Wüstenberg EG. Allergy immunotherapy for allergic rhinitis effectively prevents asthma: results from a large retrospective cohort study. J Allergy Clin Immunol. 2015;136:1511–6.

    Article  Google Scholar 

  24. 24.

    GRAZAX® (75,000 SQ-T oral lyophilisate) [summary of product characteristics]. Hamburg, Germany: ALK; 2013.

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Acknowledgements

We would like to thank all physicians and patients who participated in the study.

Funding

ALK sponsored this study and was involved in trial design, data collection, analysis and interpretation, and funded the journal’s article processing charges.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole and have given final approval to the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Disclosures

JA Schwab received remuneration from ALK for the documentation of patient data from his practice. J Schnitker was funded by ALK as Clinical Research Organisation (CRO) in the study. H Wolf is an employee of ALK and holds stock options of ALK. E Wüstenberg is an employee of ALK and holds stock options of ALK. The investigators received remuneration from ALK for the documentation of treatment of their patients. IAS GmbH received as a CRO remuneration from ALK for its services in biometrical planning, data management and statistical analysis of the study.

Compliance with ethical guidelines

The study was approved by the Ethics Committee of the Landesärztekammer Baden-Württemberg (reference no. F-2014-50) and all procedures followed were in accordance with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.

Data availability

The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Previous publication

Data of this article were published in abstract form as: Wolf H, Schnitker J, Wüstenberg E. Intra-seasonal initiation of the SQ-standardised grass sublingual tablet is well tolerated when applied by allergy specialists and allergologically experienced general practitioners. Allergy 2017;72 (Suppl. 103):760–761. (Poster presentation at the 36th EAACI-Congress, 17–21 June 2017, Helsinki, Finland).

Open Access

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Correspondence to Hendrik Wolf.

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Schwab, JA., Wolf, H., Schnitker, J. et al. Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study. Pulm Ther 4, 45–57 (2018). https://doi.org/10.1007/s41030-018-0050-1

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Keywords

  • Allergy immunotherapy tablet
  • GRAZAX®
  • In season
  • Phleum pratense
  • Rhinoconjunctivitis
  • Sublingual immunotherapy
  • Allergy immunotherapy