A 3-year randomized controlled study with sublingual immunotherapy in mite-induced respiratory allergy

Abstract

BACKgrOUND: The clinical efficacy of sublingual immunotherapy (SLIT) has been established for pollen allergy but there are few studies in mite-induced respiratory allergy. We performed a long-term evaluation of clinical effects of SLIT in patients with mite-induced rhinitis and/or asthma.METHODS: The study was randomized, double-blind and placebo-controlled. After one-year baseline assessment, 68 patients (mean age 32) with mite rhinitis and/or asthma were randomized to standard drugs+placebo or standard drugs+SLIT for 2 years. SLIT was given as soluble tablets of monomeric allergoid. Clinical scores for asthma and rhinitis (0=absent to 3=severe) and drug consumption were assessed by diary card in the period november-february. A SF-36 questionnaire was also given before and after each observation period. Pharmacoeconomy data were evaluated as well.RESULTS: 56 patients completed the study. Rate of dropouts was similar in active and placebo groups. No relevant side effect was reported during the two years of immunotherapy. There was a significant reduction of clinical scores for nasal obstruction, nasal itching and cough (p< 0.5) in the active group versus placebo and baseline. Similarly, there was a significant reduction of the drug intake scores starting from the first year. No change was observed in both groups concerning most of the SF-36 items, at baseline all patients displayed a normal profile. A significant change in SLIT group was seen for the item “change in health status”. Significantly lower he need for extra visits in the active group (25% VS 43%).CONCLUSIONS: SLIT was clinically effective in patients with mite-induced rhinitis and asthma, decreasing the medical costs. BACKgrOUND: The clinical efficacy of sublingual immunotherapy (SLIT) has been established for pollen allergy but there are few studies in mite-induced respiratory allergy. We performed a long-term evaluation of clinical effects of SLIT in patients with mite-induced rhinitis and/or asthma. METHODS: The study was randomized, double-blind and placebo-controlled. After one-year baseline assessment, 68 patients (mean age 32) with mite rhinitis and/or asthma were randomized to standard drugs+placebo or standard drugs+SLIT for 2 years. SLIT was given as soluble tablets of monomeric allergoid. Clinical scores for asthma and rhinitis (0=absent to 3=severe) and drug consumption were assessed by diary card in the period november-february. A SF-36 questionnaire was also given before and after each observation period. Pharmacoeconomy data were evaluated as well. RESULTS: 56 patients completed the study. Rate of dropouts was similar in active and placebo groups. No relevant side effect was reported during the two years of immunotherapy. There was a significant reduction of clinical scores for nasal obstruction, nasal itching and cough (p< 0.5) in the active group versus placebo and baseline. Similarly, there was a significant reduction of the drug intake scores starting from the first year. No change was observed in both groups concerning most of the SF-36 items, at baseline all patients displayed a normal profile. A significant change in SLIT group was seen for the item “change in health status”. Significantly lower he need for extra visits in the active group (25% VS 43%). CONCLUSIONS: SLIT was clinically effective in patients with mite-induced rhinitis and asthma, decreasing the medical costs.