Comparison of efficacy, safety and immunologic effects of subcutaneous and sublingual immunotherapy in birch pollinosis: a randomized study

Allergy Unit, Sant'Anna Hospital, Como, Italy.
European annals of allergy and clinical immunology 05/2007; 39(4):119-22.
Source: PubMed

ABSTRACT Sublingual immunotherapy (SLIT) is currently considered a valid option to subcutaneous immunotherapy (SCIT), but only a few studies made a direct comparison of their effectiveness. The aim of this study was to compare the clinical and immunological effects of SCIT and SLIT in pollinosis induced by Betulaceae.
Forty-seven adult patients were randomized to receive SCIT or SLIT, performed by Betulaceae (alder, birch, and hazel) extracts from Stallergenes (Antony, France) standardized in index of reactivity (IR) with the treatment schedules proposed by the producer. The clinical effects were established by symptom-medication scores recorded during the month of March. Side effects were reported directly by the physicians for SCIT and were registered in diary cards by the patients for SLIT. Immunologic evaluation was done by measuring specific IgE and IgG4 to Bet v 1.
Thirty-four patients (19 for SCIT and 15 for SLIT) completed the registration of symptoms and drug consumption during pollen period of Betulaceae. Mean cumulative doses of respectively 50.65 IR by SCIT and 4653.1 IR by SLIT were administered, with a SLIT/SCIT ratio of 92. There was no significant difference in mean symptom-medication score between SCIT and SLIT. Systemic reactions occurred in 16% of SCIT treated but in none of SLIT treated. As to immunologic evaluation, Bet v 1 specific IgE did not rise after the pollen season in SCIT treated, while increased non significantly in SLIT treated. Bet v 1 specific IgG4 increased in both treatment, buy only the increase with SCIT was significant (p = 0.001).
SLIT and SCIT with a ratio of about 100 are equally effective in controlling rhinoconjunctivitis caused by tree pollen allergy. SLIT is safer than SCIT, but does not show the same immunologic effects on serum specific IgE and lgG4 antibodies.

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    • "No change in QoL. Mauro et al, 19 2007 Birch (4 mo) SCIT 5 23/8 SLIT 5 24/5 "
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    ABSTRACT: Sublingual allergen immunotherapy provides a new option for patients with allergic rhinitis in the United States. The efficacy of these sublingual immunotherapy tablets in the treatment of allergic rhinitis has been firmly established in large multicenter clinical trials. In addition, the clinical benefits of sublingual immunotherapy might persist after treatment is discontinued. Local reactions, such as gastrointestinal or oropharyngeal symptoms, are common. However, severe anaphylaxis is rare, and therefore the immunotherapy tablets can be administered at home. Sublingual immunotherapy for allergic rhinitis has been used successfully for years in Europe, and these products might be appropriate for patients who do not do well with standard drug therapy or for those who prefer a disease-modifying approach.
    The Journal of allergy and clinical immunology 09/2015; DOI:10.1016/j.jaci.2015.06.046 · 11.48 Impact Factor
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    • "From the specific IgG assessments, a two-fold increase in specific IgG/IgG4 concentrations was observed in both treatment groups, supporting the immunogenic effect of both products. These results are comparable with the increase in IgG levels reported after sublingual immunotherapy with Staloral Birch [21]. Similarly, in a study with grass pollen SLIT the increase was also approximately two-fold after four months. "
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    ABSTRACT: Background: SUBLIVAC FIX Birch (SUB-B) is a liquid oral preparation of Betula verrucosa pollen extract for the treatment of allergic rhinitis/rhinoconjuctivitis induced by birch pollen. The major allergen content of SUB-B and Staloral Birch (Stal-B) have been shown to be comparable. In order to compare the clinical efficacy and safety of both products, the present study was designed to investigate efficacy of treatment with SUB-B compared to Stal-B by means of reduction in allergy symptoms assessed by a titrated nasal provocation test (TNPT) in subjects suffering from IgE mediated allergy complaints triggered by birch pollen. Methods: A prospective, randomized, open, blinded endpoint (PROBE), controlled, single-centre study in 74 birch allergic adults was performed. Treatment consisted of either SUB-B (10,000 AUN/ml) or Stal-B (initial phase 10 I.R./ml and maintenance phase 300 I.R./ml) for 16-20 weeks at maintenance dose. The primary efficacy outcome was defined by the difference in change of the TNPT-threshold dose between the two treatment groups at baseline and after completion of treatment. Secondary outcomes included determination of birch pollen specific IgE and IgG levels, safety lab and ECG. During the first 30 days of treatment, subjects were requested to fill out a diary concerning compliance with study medication, occurrence of AEs and the use of concomitant medication. Results: Analysis of the primary efficacy parameter showed that the percentage of subjects showing a beneficial treatment effect was similar in both treatment groups, 33.3% for SUB-B vs. 31.4% for Stal-B in the intention to treat population. Evaluation of the immunologic response, showed that treatment with SUB-B and Stal-B induced similar increases (approximately 2 times) in IgE, IgG and IgG4 specific for Bet v 1. In total, 143 related adverse events (AEs) were reported. The majority of the AEs was of mild intensity. The same pattern of AEs was observed for both products. No clinically relevant changes in other safety parameters, such as safety laboratory parameters, vital signs, physical examination and ECGs were observed. Conclusion: Taken together, treatment with both products was effective by means of reduction in allergic symptoms during a TNPT. In addition, safety analysis revealed a good tolerability of both SLIT extracts.
    07/2014; 4:23. DOI:10.1186/2045-7022-4-23
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    ABSTRACT: Recent reports of the prevalence of allergic rhinitis in the United States range from 20 to 40 % of the population. Typical symptoms can include nasal obstruction, rhinorrhea, sneezing, and conjunctivitis. Inhalant allergens, such as plant pollens, can cause seasonal symptoms, while perennial symptoms can be induced by dust mites, cockroaches, and certain molds. Allergen specific immunotherapy (SIT) is typically recommended for patients whose allergic rhinoconjunctivitis symptoms cannot be controlled by medications and environmental controls, cannot tolerate their medications, or desire an alternative to pharmacotherapy. While currently the only FDA approved form of SIT in the United States involves subcutaneous injection, sublingual immunotherapy is an alternative “off-label” form of allergen desensitization. This review article examines the efficacy and safety of sublingual immunotherapy for the treatment of allergic rhinitis.
    06/2013; 1(2). DOI:10.1007/s40136-013-0010-0
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