Safety of sublingual-swallow immunotherapy: An analysis of published studies

Stallergénes, Scientific Department, Milan, Italy.
Clinical & Experimental Allergy (Impact Factor: 4.77). 05/2005; 35(5):565-71. DOI: 10.1111/j.1365-2222.2005.02240.x
Source: PubMed


As the main target of sublingual immunotherapy (SLIT) is to reduce at most the occurrence of adverse events (AE), safety represents a critical issue. This aspect deserves particular mention when a higher dose of allergen extract than traditional subcutaneous immunotherapy (SCIT) is required to be effective: that may be up to 500 times that employed for SCIT.
All published controlled studies concerning SLIT-swallow were analysed to evaluate AE rates.
Studies were subdivided in two groups: (i) studies using low allergen dose (LAD), i.e. ranging from 1 to 50 times the dose commonly administered with SCIT, and (ii) studies with high allergen dose (HAD), i.e. ranging from 50 to 500 times the dose administered with SCIT.
Twenty-five studies were altogether analysed: 13 studies belonged to the low-dose group, 12 belonged to the high-dose group. We considered all patients with at least one AE. Local reactions were significantly more frequent in the LAD group than in the HAD group (P<0.0001), while there was no difference in the rate of systemic reactions. Severe systemic reactions were never reported.
This study represents the first analysis of the safety of SLIT concerning the allergen dose employed in the treatment. There is evidence that AE occurrence is substantially not dose-dependent. This fact highlights two main clinical aspects: the elevated tolerability of SLIT in general and the safety of HAD regimen.

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    • "The 100,000 SQ unit regimen was more effective, but the 10,000 SQ unit regimen caused fewer side effects.12 It is surprising that no other study has been done in this area, either with SCIT or SLIT, that has the advantage of being much better tolerated.21 In addition, SLIT meets the requirements for use as treatment for pollen-allergic patients because it has the highest evidence of efficacy as demonstrated by meta-analyses4–8,10 and offers benefit over SCIT in terms of compliance and pharmacoeconomic aspects.22 "
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    ABSTRACT: An important subpopulation in allergic rhinitis is represented by patients with severe form of disease that is not responsive to drug treatment. It has been reported that grass pollen subcutaneous immunotherapy is effective in drug-resistant patients. In a real-life study, we evaluated the efficacy of 5-grass pollen tablets in patients with grass pollen-induced allergic rhinitis not responsive to drug therapy. We carried out this multicenter observational study in adults and adolescents with grass-induced allergic rhinitis not responsive to drug therapy who were treated for a year with 5-grass pollen tablets. Clinical data collected before and after sublingual immunotherapy (SLIT) included Allergic Rhinitis and its Impact on Asthma (ARIA) classification of allergic rhinitis, response to therapy, and patient satisfaction. Forty-seven patients entered the study. By ARIA classification, three patients had moderate to severe intermittent allergic rhinitis, ten had mild persistent allergic rhinitis, and 34 had moderate to severe persistent allergic rhinitis. There were no cases of mild intermittent allergic rhinitis before SLIT. After SLIT, 33 patients had mild intermittent allergic rhinitis, none had moderate to severe intermittent allergic rhinitis, seven had mild persistent allergic rhinitis, and seven had moderate to severe persistent allergic rhinitis. The mean medication score decreased from 4.2±1.3 before to 2.4±2.0 after SLIT (P<0.01), representing a reduction of 42%. The response to treatment before SLIT was judged as poor by 70% of patients and very poor by 30%. Patient satisfaction was significantly increased after SLIT (P<0.01). In real life, most patients with grass pollen-induced allergic rhinitis not responsive to drug treatment can achieve control of the condition with one season of treatment using 5-grass pollen tablets.
    Journal of Asthma and Allergy 12/2013; 6(6):127-33. DOI:10.2147/JAA.S53801
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    • "According to a comprehensive review of published DBPC study, the adverse event rates were 23% in SLIT group and 12% in placebo group, and systemic events were 17% and 12%, respectively. Adverse event occurrences were not dose dependent and severe systemic reactions were not reported [47]. However, one DBPC study reported treatment related adverse events, irritation of the throat, and itching sensations in the mouth and ears, increased with dose [48]. "
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    ABSTRACT: Current treatment options for allergic rhinitis (AR) include allergen avoidance and environmental control, pharmacotherapy, nasal surgery and immunotherapy. Among these, immunotherapy is the only therapeutic option that modifies fundamental immunologic mechanism by inducing desensitization. Specific allergen immunotherapy has been used for 1 century since 1911 and subcutaneous immunotherapy (SCIT) has been demonstrated to be effective in asthma and AR. However, SCIT has several disadvantages such as inconvenience, invasiveness and potentially severe systemic reactions. Thus, sublingual immunotherapy (SLIT) has recently received much attention around the world as a treatment for AR and is now widely used to replace the subcutaneous route. SLIT has recently been introduced in Korea and is now available for AR treatment in the Asia-Pacific region. This review offers better understanding of SLIT for AR by summarizing published articles and our previous works regarding proposed mechanisms, indication and efficacy, safety and adverse events, and compliance.
    10/2011; 1(3):123-9. DOI:10.5415/apallergy.2011.1.3.123
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    • "Specific reviews on safety are also available that address only children22,23 or patients of any age.24,25 Of note, differently from SCIT, there was not a dose dependence of safety, as the rate of systemic reactions was similar in studies using low doses and in studies using high doses.24 In a subsequent trial evaluating seven groups of patients treated with increasing doses, the treatment-related adverse events, including irritation of the throat, and itching sensations in the mouth and ears, increased with dose.26 "
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    ABSTRACT: Allergic rhinitis is a very common disease affecting about 20% of people. It may be treated by allergen avoidance when possible, by antiallergic drugs such as antihistamines and topical corticosteroids, and by allergen-specific immunotherapy. The latter is the only treatment able to act on the causes and not only on the symptoms of respiratory allergy and is able to maintain its efficacy even after stopping, provided an adequate duration of treatment of 3-5 years is ensured. Sublingual immunotherapy (SLIT) was introduced in the 1990s as a possible solution to the problem of adverse systemic reactions to subcutaneous immunotherapy and has been demonstrated by more than 50 trials and globally evaluated thus far by five meta-analyses as an effective and safe treatment for allergic rhinitis. Life-threatening reactions are extremely rare. However, it is important to note that clinical efficacy occurs only if SLIT meets its needs, ie, sufficiently high doses are regularly administered for at least 3 consecutive years. This is often overlooked in the current practice and may prevent the same success reported by trials from being achieved.
    Journal of Asthma and Allergy 02/2011; 4(4):13-7. DOI:10.2147/JAA.S16632
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