Long-lasting effects of sublingual immunotherapy according to its duration: A 15-year prospective study

Pneumology Unit, Cuasso al Monte, Macchi Hospital Foundation, Varese, Italy.
The Journal of allergy and clinical immunology (Impact Factor: 11.48). 10/2010; 126(5):969-75. DOI: 10.1016/j.jaci.2010.08.030
Source: PubMed


Data on the long-term effects of sublingual immunotherapy (SLIT) are sparse, and the optimal duration of treatment is a matter of debate.
We sought to prospectively evaluate the long-term effect of SLIT given for 3, 4, or 5 years and to compare the effect of those different durations.
In this prospective open controlled study we followed up patients with respiratory allergy who were monosensitized to mites for 15 years. The subjects were divided in 4 groups receiving drug therapy alone or SLIT for 3, 4, or 5 years. Clinical scores, skin sensitizations, methacholine reactivity, and nasal eosinophil counts were evaluated every year during the winter months. The clinical effect was considered to persist until clinical scores remained at less than 50% of the baseline value, and then patients underwent another course of SLIT.
Seventy-eight patients were enrolled, and 59 completed the study. In the 12 control subjects no relevant change in clinical scores was seen throughout the study. In the patients receiving SLIT for 3 years, the clinical benefit persisted for 7 years. In those receiving immunotherapy for 4 or 5 years, the clinical benefit persisted for 8 years. New sensitizations occurred in all the control subjects over 15 years and in less than a quarter of the patients receiving SLIT (21%, 12%, and 11%, respectively). The second course of vaccination induced a benefit more rapidly than the first course. The behavior of bronchial hyperreactivity and nasal eosinophils paralleled the clinical score.
Under the present conditions, it can be suggested that a 4-year duration of SLIT is the optimal choice because it induces a long-lasting clinical improvement similar to that seen with a 5-year course and greater than that of a 3-year vaccination.

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Available from: Maurizio Marogna, Feb 22, 2015
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    • "Na podstawie dostępnych badań można przyjąć, że największą skutecznością cechują się szczepionki zawierające alergeny pyłku traw i brzozy [9] [54]. Szczególnie istotny jest długotrwały efekt kliniczny utrzymujący się po zaprzestaniu SLIT, który wykazano u pacjentów leczonych z powodu uczulenia na pyłek traw oraz roztocze kurzu domowego [50] [55]. Szczególnie ważnym zagadnieniem jest skuteczność SLIT w grupie pacjentów pediatrycznych. "
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    ABSTRACT: SLIT (sublingual immunotherapy) is a therapeutic method aiming at producing allergen-specific tolerance of the immune system to a gradually increasing dose of an allergen that is administered sublingually. SLIT initiates similar immune mechanisms as does subcutaneous immunotherapy (SCIT). The aim of the study at this position is to update the current knowledge on sublingual immunotherapy. Randomized double-blind, placebo-controlled (RDBPC) studies that compared both immunotherapy forms point to an advantage of SCIT over SLIT in decreasing symptoms of asthma and allergic rhinitis, a comparable effect of both the methods on immune parameters (sIgE, IL-10) and upper respiratory tract inflammations and an advantage of SCIT over SLIT with respect to lower respiratory tract inflammations as based on provocation tests. At present, there are no grounds for recommending SLIT in food allergy. In view of the high safety profile and absence of anxiety-provoking infections, SLIT may be the method that is more often selected in children as compared to adults. On the other hand, immune mechanisms and results of clinical trials provide an argument for preferential employment of SCIT in adults. It should be borne in mind, however, that SLIT is effective if a good quality vaccine with a high allergen dose, is employed for at least three years. National and international reports indicate the necessity of conducting further clinical trials, especially including a direct comparison between SCIT and SLIT with respect to effectiveness and safety.
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    • "A prospective, open, controlled, 4-parallel-group partially randomized study involving adults patients (aged 18–65 years) with AR and mild intermittent asthma due to HDM allergy was designed to evaluate the long-term effects of HDM SLIT according to the duration of the treatment[58]. Patients were placed into an active group receiving a glycerinated solution of HDM plus drugs or in a control group treated with drugs only. "
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    ABSTRACT: Allergy Immunotherapy is the only treatment able to modify the natural history of the respiratory allergic disease. It is indicated in IgE-mediated rhinoconjunctivitis and/or allergic asthma in both children and adults whenever more than occasional use of anti-inflammatory or controller medications is needed. Only well-standardized products should be used after precise diagnosis has been achieved. Efficacy of allergen immunotherapy (AIT) with mite and pollen extracts persist once treatment is discontinued, and for that AIT may be considered the only treatment able to change the natural history of the allergic disease. Key points 1. The strongest risk for developing asthma occurred in those patients with rhinitis and sensitization to several inhalant allergens, particularly house dust mites. 2. The role of allergen avoidance measures in the evolution of the respiratory disease is unknown. 3. AIT is indicated for rhinoconjunctivitis and/or asthma due to allergy to inhalants. In both cases, it is preferable to initiate the treatment as soon as possible, before chronic irreversible changes occur. 4. According to the European Medicines Agency (EMA), long-term efficacy can be defined as “the prolonged clinically relevant benefit that persists after stopping the treatment”. 5. Long-term efficacy of AIT has been demonstrated for both mite and pollen AIT in children and adults.
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    • "In a further study, the same authors prospectively evaluated the long-term effect of SLIT given for 3, 4, or 5 years on 78 patients, 59 of whom completed the study, compared with 12 control subjects. The total duration of the follow-up was 15 years [27]. According to new sensitizations, all the control subjects over the 15 years period developed positive test to allergens previously negative, while this occurred in less than a quarter of the patients receiving SLIT (21% in treated for 3 years, 12%, in treated for 4 years, and 11% in treated for 5 years, respectively). "
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