Optimum treatment strategies for polyallergic patients – analysis of a large observational trial

Abstract

Objectives:

To document the effectiveness and safety of sublingual allergen immunotherapy (SLIT) with a five-grass pollen tablet (Oralair) and compare different treatment options in a broad, non-selected population of patients in a real-world clinical setting.

Research design and methods:

This was a 2 year, open, prospective, multicenter, single-arm, non-interventional study. Patients with a history of clinically relevant allergic symptoms caused by grass pollen, confirmed by skin prick testing, received treatment with the five-grass pollen tablet. Concomitant treatment with symptomatic medication and/or additional SLIT or subcutaneous immunotherapy (SCIT) was permitted. Twelve-month data are presented here. Effectiveness was assessed comparing a combined rhinoconjunctivitis (RC) score derived from the severity of rhinitis and conjunctivitis symptoms under treatment with retrospective data of the previous year.

Results:

A total of 1408 patients participated in the study, of whom 434 were children/adolescents and 962 polyallergic. Compared with the grass pollen season preceding five-grass pollen tablet treatment, a statistically significant reduction of 49.9% was achieved in RC score for the total population (p < 0.001), and an improvement in overall health was perceived by 90.9% of patients. The overall population of polyallergic patients derived similar benefits from treatment with the five-grass pollen tablet as monoallergic patients. The percentage reduction in RC score was larger in polyallergic patients taking no additional therapy (60.2%) than in those taking concomitant symptomatic medication (38.1%) or allergen immunotherapy (AIT) (50.8%). Within the last of these groups, RC score improved by 47.6% among patients receiving additional SCIT, versus 54.8% with additional SLIT. Adverse drug reactions, reported in 15.3% of study participants, were mostly local in nature and mild or moderate in intensity.

Conclusions:

After 1 year of treatment, polyallergic patients responded similarly to the five-grass pollen tablet as monoallergic patients. For polyallergic patients in whom additional treatment was needed, a second SLIT may be more beneficial than a SCIT or symptomatic co-medication.

Keywords: :

• Allergen immunotherapy
• Allergic rhinitis
• Polyallergy
• Polysensitization
• Subcutaneous immunotherapy
• Sublingual immunotherapy

Transparency

Declaration of funding

Stallergenes GmbH, Germany sponsored this study and funded medical writing/language editing support.

Author contributions: RM was the principal investigator of the trial and contributed to the protocol design, EK and MH contributed to the analysis and interpretation of the data. KS performed the statistical analysis. KM wrote and RM, KS, MH and EK critically revised the manuscript. All authors approve of this final version of the manuscript.

Declaration of financial/other relationships

K.M. and K.S.-H. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. M.H. and E.K. have disclosed that they are employees of Stallergenes. R.M. has disclosed that he has received personal fees from ALK-Abello, personal fees from Allergy Therapeutics, personal fees from Allergopharma, grants and personal fees from Bencard, grants and personal fees from BiotechTools, personal fees from Bayer, personal fees from GSK, grants from HAL, personal fees from Johnson + Johnson, grants and personal fees from Lofarma, personal fees from MSD, personal fees from Menarini, personal fees from Faes, personal fees from Novartis, personal fees from Leti, grants from Optima, non-financial support from Greer, non-financial support from Roxall, grants from AIPrevent, personal fees from Servier, personal fees from Stada, grants and personal fees from Stallergènes, personal fees and non-financial support from UCB, grants from Ursapharm, grants from Bitop, grants from Hulka, non-financial support from Atmos, grants and personal fees from Arthrocare, personal fees from Meda, personal fees from Ohropax, outside the submitted work. R.M. has disclosed that he is a member of the guidelines task force of the German Academy of Otorhinolaryngology, the chairman of ISCOANA, the International Standardization Committee of the European Rhinologic Society (ERS), the chairman of the ENT-Section of the European Academy of Allergy, Asthma and Clinical Immunology (EAACI), and a vice-president of INTERASMA.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

IMSIE received a Clinical Research Organization (CRO) remuneration from Stallergenes for its services in study planning and management, biometrical planning, data management, statistical analysis and interpretation of the study. The investigators received remuneration from Stallergenes for documentation of treatment of the patients. The authors would like to thank all investigators who provided data on treatment of their patients for the study. Medical writing/language editing support was provided by Marie-Josefine Joisten (IMSIE, Cologne, Germany) and Ken Sutor (Newmed Publishing Services, Chester, UK).

Previous presentation: Parts of the data in this article were published in abstract form in Karagiannis E, Hadler M, Shah-Hosseini K, et al. Sublinguale Immuntherapie (SLIT) mit der 5-Graeserpollen-Tablette in der Routineversorgung von Patienten mit unterschiedlichen klinischen Profilen. Allergo J 2012;21:S59 (poster presentation at the 7th German Allergy Congress, 11–13 October 2012, Munich, Germany). Additional results from the study (not presented in this article) were presented at numerous congresses between 2012 and 2015.

Notes

*Oralair is a registered trade name of Stallergenes, Antony, France

*Oralair is a registered trade name of Stallergenes, Antony, France