Short-term immunotherapy, results of a PMS study

Background: Specific immunotherapy (SIT) for respiratory allergies is a well-established treatment, but the commonly prolonged injection regime has inhibited wide application. This problem has recently been addressed by the introduction of a 4-injection SIT vaccine incorporating a TH1 adjuvant, Monophosphoryl lipid A (MPL(R)). This vaccine (POLLINEX Quattro) has shown promise in controlled clinical trials but more data were required from larger populations of patients in a real life setting. We report the results of a post-marketing surveillance study of short-term SIT monitoring efficacy and tolerability in the treatment of seasonal allergic rhinoconjunctivitis with or without asthma. Patients and methods: Patients allergic to pollen from grasses, trees, mugwort and plantain were treated, using appropriate combinations of these allergens (as allergoids) in the vaccine. Efficacy was estimated by medication use and symptoms in comparison to the previous pollen season. Tolerability was assessed by the frequency and intensity of adverse reactions. Results: From a total of 1,736 patients, reduced medication was required by 62.2% of patients and reduced symptoms were found in 82.4%. Reduction in medication consumption was found to be highly significant (p = 0.001).These treatment effects were not affected by the time in the year the treatment was given. Patients treated more close or more distant to the pollen season showed similar benefits. Local reactions were experienced by 8% of injections and were mostly mild/moderate, consisting of redness, swelling, itching or pain at the injection site. Systemic reactions (mainly mild, consisting of rhinitis, conjunctivitis, dyspnoea and urticaria) were seen in 0.7% of the injections. Local and systemic reactions occurred in 0.6% of injections. No patient had unexpected side-effects. Self-assessment of acceptability of treatment was good or very good in 89.5% of patients. In 7.9% of patients problems with local reactions were reported. Conclusion: Shortterm SIT for allergic rhinoconjunctivitis with or without asthma using 4 injections of an MPL(R) adjuvanted allergy vaccine provided good efficacy and tolerability in a large number of patients in daily practice.