Efficacy and safety of subcutaneous immunotherapy with polymerized allergen mixtures in polyallergic patients – ARES observational study

ABSTRACT

Background

Administration of allergen mixtures of many components comprises the most common approach for American allergists regarding the management of polyallergic patients. European allergists, however, are more reluctant to this type of treatment due to the potential drawbacks of mixing extracts.

Research design and methods

To assess the efficacy and safety of subcutaneous immunotherapy (SCIT) with polymerized allergen mixtures without dilutional effect in polyallergic patients.

This observational, prospective, multicenter study included patients (between 5 and 60 years) with respiratory allergic diseases that had been prescribed with SCIT with mixtures of two pollen or mite extracts. Changes in Symptoms and Medication Score (SMS) and in rhinitis quality of life questionnaire (RQLQ), subjective clinical improvement, treatment satisfaction and tolerability were assessed after the 1-year treatment.

Results

A total of 115 patients were included in the assessment. Mean global SMS decreased from 3.5 (SD = 1.1) to 1.6 (SD = 1.2) points, with a mean absolute reduction of 1.6 (SD = 1.3) points in the RQLQ score (p < 0.001, Wilcoxon test). General subjective clinical improvements and a good treatment satisfaction and tolerability were observed.

Conclusion

SCIT with polymerized allergen mixtures from either pollen or mite extracts proved to be an effective and safe treatment option for polyallergic patients suffering from allergic respiratory diseases.

KEYWORDS:

• Allergic rhinitis
• allergic rhinoconjunctivitis
• polyallergy
• allergen mixtures
• polymerized extracts

Article highlights

• Administration of allergen mixtures in AIT is the most practical treatment option for polyallergic patients. This strategy reduces the significant time invested in the administration of separate vaccines by administering a unique vaccine that includes all the relevant allergens that a patient is allergic to, retaining the ability to induce immune tolerance and reduce allergy symptoms.

• Currently, while the administration of allergen mixtures is part of the common clinical practice for most allergists in the United States, European allergists are still quite reluctant to this approach due to the potential drawbacks of mixtures, being the dilution of extracts one of the main ones.

• This observational study had as objective to explore in polyallergic patients with allergic respiratory diseases (AR/ARC with or without AA) the 1-year efficacy and safety of a SCIT preparation (Allergovac Poliplus^®, ROXALL Medicina España S.A.) that is made up of a mixture, with no dilutional effect, of two polymerized extracts from either pollen or mite sources.

• The SCIT treatment, which contained the optimal therapeutic dose for each allergen extract, caused statistically significant improvements in allergy symptoms and QoL of patients (p < 0.001), with almost all patients reporting improvements in the subjective global clinical status of their pathology and being satisfied or very satisfied with the treatment’s effect after the 1-year treatment.

• Polymerization, which has proven to reduce the IgE-binding capacity of allergen extracts while preserving T-cell reactivity, allowed to follow cluster administration schedules with very good safety results. No patient suffered any serious TEAE and all reported TEAEs ended with full recovery of the patient. Only one patient (0.9%) suffered a systemic reaction, and it was of grade I.

• SCIT with polymerized allergen mixtures from pollens or mites showed to be an effective and safe treatment option for polyallergic patients suffering from allergic respiratory diseases.

Declaration of interest

L Begoña, B Madariaga and A Vazquez belong to the Medical Department of ROXALL Medicina España S.A, the company sponsor of this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

M Santaolalla was the coordinating investigator responsible for supporting the general conduct of the study and giving the approval of manuscript final version to be published. J Arias-Irigoyen, J Soler, JDuque, R Escudero, J Pérez-Formoso, T Lobera, M Rueda, C Alias, H Hermida and C Vela were the principal investigators of the sites involved in the study, conducting the research and the investigation process. L Begoña, B Madariaga and A Vazquez were responsible for the design of the study, data management & statistics, results analysis and interpretation, and the final manuscript preparation.

Ethics statement

The study was conducted in accordance with the principles of the Declaration of Helsinki and the ICH guideline on Good clinical practices.

Study approval statement

This study was reviewed and approved by a Spanish clinical research ethics committee (CEIm La Rioja; approval reference: CEImLAR EPA-SP 91), and all the involved regional competent authorities, according to Spanish regulation.

Consent to participate statement

Written informed consent was obtained from participants (or their parent/legal guardian/next of kin) to participate in the study.

Data availability statement

All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding authors.

Acknowledgments

The authors thank all the remaining collaborating investigators who had participated in each of the study sites.

This study has been previously presented in poster sessions of the following congresses:

European Academy of Allergy and Clinical Immunology (EAACI) congress

• 2021:

  Santaolalla M, Arias-Irigoyen J, Soler JM et al. Evaluation of efficacy and safety of polymerized multiallergen immunotherapy in polysensitized patients: ARES STUDY. Presented at: EAACI Hybrid congress 2021. Krakow, Poland, 10–12 July 2021.

Spanish Society of Allergology and Clinical Immunology (SEAIC) congress

• 2021:

  Santaolalla M, Arias-Irigoyen J, Escudero R et al. Evaluación de la eficacia y seguridad del tratamiento con Allergovac Poliplus, alergoide sin efecto dilucional, en niños y adolescentes polialérgicos a ácaros o a pólenes con rinitis o rinoconjuntivitis alérgica. Presented at: XXXIII Congreso SEAIC- Zaragoza 2021. Zaragoza, Spain, 20–23 October 2021.

• 2022:

  Santaolalla M, Arias-Irigoyen J, Soler JM et al. Evaluación de la eficacia y seguridad de la inmunoterapia polimerizada multialergénica en pacientes polisensibilizados a pólenes o a ácaros: resultados finales del estudio observacional ARES. Presented at: Simposio Internacional SEAIC 2022. Palma de Mallorca, Spain, 26–29 October 2022.

Additional information

Funding

This study has been funded by ROXALL Medicina España S.A.