Hypoallergenic high-dose immunotherapy proves effective and safe in a multicentre surveillance study

Background: The safety and efficacy of subcutaneous immunotherapy (SCIT) with the high-dose hypoallergenic preparations Allergovit® have been well documented in several randomised clinical trials. The following study aimed to confirm these results in daily practice.

Methods: A total of 221 office-based allergologists in Germany participated in a prospective post-marketing observational study. Data on the effectiveness and safety of Allergovit® were collected from 2,931 patients (3,008 therapies) with seasonal IgE-mediated allergies and clinical symptoms (e. g. rhinitis, conjunctivitis, asthma) during the respective pollen seasons; the patients were hyposensitised with the allergen-specific high-dose hypoallergenic preparations. Data were collected via structured questionnaires. The documentation included the case history, clinical sensitisation groups (trees, grasses, weeds, mites, moulds, pets, food or other), injections, anti-symptomatic medication, adverse events, and assessment of the first treatment cycle. Patients assessed their conditions on a visual analogue scale (VAS) from 1 (very good) to 10 (very bad) for the preceding season when entering the study and again after the end of the following pollen season and on completion of the first SCIT cycle. Additionally, doctors evaluated patient health as well as the tolerability of the treatment.

Results: The study included 46 % male and 54 % female patients (5–79 years); 15 % were children (5–14 years). Clinically manifest sensitisations were seen for a wide allergen range, and 49 % of the subjects were sensitised to more than one allergen group. After one treatment cycle, a very good efficacy for the first pollen season was seen in terms of improvement on the VAS (median: 3 scores) in comparison to the preceding season. In 86 % of treatments, a clinically relevant improvement of 2 or more scores was documented, whilst 69 % of patients were able to use less anti-symptomatic medication. Adverse events were reported in 8 % of all 27,109 injections, 99 % of them were local reactions (wheal diameter > 4 cm). Patients wanted to continue SCIT after the first therapy cycle in 95 % of cases.

Conclusion: SCIT with the high-dose hypoallergenic Allergovit ® was well tolerated and effective in allergologists’ daily practice. The patients’ conditions improved remarkably, while the concomitant use of symptomatic medication was clearly reduced. These positive effects were observed after only one treatment cycle already.