Healthy Skepticism Library item: 10637

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Publication type: Journal Article

Drachenberg KJ, Proll S, Urban E, Woroniecki SR.
Short-term immunotherapy using an allergy vaccine adjuvanted with monophosphoryl lipid A: A post-marketing surveillance study
International Review of Allergology and Clinical Immunology. 2002; 8:(4):219-223

Abstract:

Treatment of respiratory allergies by specific immunotherapy (SIT) can often provide a successful outcome, but prescription of a long injection regime undoubtedly discourages widespread use. A recent innovation in SIT has been the introduction of a novel adjuvant, monophosphoryl lipid A (MPLR) in an improved allergy vaccine formulation. MPLR has a potential to improve efficacy by promoting a Th1 response which should in turn promote the effectiveness of SIT and thus allow shorter courses. So far, this vaccine has provided encouraging outcomes in controlled clinical trials but more data were required from larger populations of patients in a real life setting. We report here a post-marketing surveillance (PMS) study of short-term SIT monitoring efficacy and tolerability of this vaccine in the treatment of seasonal allergic rhinoconjunctivitis and/or asthma. SIT was prescribed for patients with allergies to pollen from grasses, rye, trees, mugwort and plantain, using appropriate combinations of these allergens (as allergoids) in the vaccine. Efficacy was estimated by medication use and symptoms in comparison to those recorded for the previous pollination season. Tolerability was assessed by the frequency and intensity of local and systemic adverse reactions. From the total of 1736 patients, reduced medication was required by 62.2% of patients and reduced symptoms were found in 82.4%. There was a highly significant reduction in medication consumption (p=0.001). These outcomes were unaffected by the short time interval between the treatment beginning and the pollination season. Local reactions were experienced from 8.6% of the injections and were mostly mild/moderate, consisting of redness, swelling, itching or pain at the injection site. Systemic reactions resulted from 1.3% of the injections and were mainly mild, consisting of rhinitis, conjunctivitis, dyspnoea, urticaria and fatigue. No patient had unexpected side-effects. Self-assessment of acceptability was rated as good or very good by 89.5% of patients. In conclusion, short-term SIT for allergic rhinitis/asthma using four injections of an MPLR-adjuvanted vaccine provided good efficacy and tolerability for a large number of patients in daily practice.