Short-term immunotherapy with allergoids:: Results of a prospective, open study in allergologist's practices

Background: Various controlled clinical trials have proven the efficacy and safety of a short-term specific immunotherapy (SIT) with 7 injections. This post-marketing surveillance study should show whether the good results are confirmed in a large number of patients in allergologists' practices. Methods: In a post-marketing surveillance study, 2,047 patients with allergic rhinoconjunctivitis, asthma and neurodermatitis were treated for at least 1 season (1 year) with an allergoid preparation adsorbed to aluminium hydroxide (Allergovit). Doses were given in accordance with the package insert. Efficacy was measured by physician's and patient's self-assessment on an interval scale and by the use of anti-symptomatic medication. Safety was shown in terms of local and systemic reactions, and compliance by the number of drop-outs. Results: In total, case report forms for 2,435 years of therapy were evaluated. After I year of therapy, 81% of patients showed a relevant improvement in their condition. After an improvement of 3 points (median) on a 10-point interval scale at the end of the first year, the efficacy improved still further in the second and third years of therapy (p < 0,001). The intake of systemic antihistamines could be reduced by 36%, of local mast cell stabilizers and corticosteroids by 44% and 42%, respectively. The time of the start of SIT had no influence on the success of the therapy whereas underdosing of the preparation resulted in less efficacy. The response of children and patients above 50 years of age were not different compared to those of the other patients. Patients with clinically relevant sensitizations against 3 or more allergen families showed a trend (p = 0,148) towards less efficacy, probably because of symptoms attributable to other sensitisations. Local reactions were seen in association with 241 (1.1%) of the injections and systemic reactions with 48 (0,3%). The systemic reactions were mainly rhinitis, conjunctivitis, difficulties in breathing and cutaneous reactions. Severe systemic reactions were not observed. In 97% of the cases, the physicians judged the tolerance of the therapy as good. After the first 2 years of therapy, 95% of the patients wanted to continue the treatment. In total, nearly 5% of the patients droped out. Conclusion The short-term SIT with allergoids (7 injections) showed a good efficacy and safety in the allergologist's practice. SIT is also suitable for children and elderly patients. Treatment should start early during the course of disease because the chance of success decreases with rising numbers of clinically manifest sensitizations.