Sublingual-swallow immunotherapy with standardized 3-grass pollen extract: a double-blind, placebo-controlled study

Blay, F. De; Barnig, C.; Kanny, G.; Purohit, Ashok; Leynadier, F.; Lara, Jacinto; Chabane, H.; Guérin, Laurence

doi:10.1016/s1081-1206(10)60571-6

Cited by 47 publications

(49 citation statements)

References 16 publications

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“…1). They comprised a total of 3160 SIT-treated participants [SCIT with natural extracts: 440 subjects in seven trials (17)(18)(19)(20)(21)(22)(23); SCIT with allergoids: 168 SIT-treated subjects in three trials (24)(25)(26); SLIT with natural extract drops: 906 SIT-treated subjects in 16 trials (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42); SLIT with allergoid tablets: 41 SIT-treated subjects in two trials (43,44); SLIT with natural extract tablets: 1605 SIT-treated subjects in five trials (45)(46)(47)(48)(49)(50)]. The main reasons for excluding studies were lack of double-blinding/ randomization, review articles, multiple allergen extracts, outcomes unrelated to efficacy and preparations that are not commercially available.…”

Section: Resultsmentioning

confidence: 99%

“…These variations may have contributed to the heterogeneity of the trial outcomes, with variously (i) a significant difference in favour of SIT in the median total symptom score over the whole pollen season (33), (ii) an effect on medication scores (29), (iii) an effect on symptom scores for the pollen peak or at certain time points (27,28), (iv) an improvement in investigator-assessed allergic complaints only (30) or (v) no SIT effect on efficacy parameters (31). The role of asthma status was mentioned by de Blay et al (32) in a population of 118 randomized subjects; although no significant, overall effects of SIT on efficacy scores were apparent, a subgroup analysis revealed a significant (P < 0.045) symptom reduction in nonasthmatic patients. Four adult studies addressed the long-term and/or seasonto-season effects of SLIT drops and are described further below.…”

Section: Slit Grass Pollen Natural Extracts (Drops)mentioning

confidence: 99%

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Towards evidence‐based medicine in specific grass pollen immunotherapy

Calderón

Mösges

Hellmich

et al. 2010

Allergy

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To cite this article: Calderon M, Mö sges R, Hellmich M, Demoly P. Towards evidence-based medicine in specific grass pollen immunotherapy. Allergy 2010; 65: 420-434.We performed a systematic, evidence-based medicine (EBM) review of double-blind, placebo-controlled randomized clinical trials (DBPC RCTs) of commercially available grass pollen-specific immunotherapy (SIT) modalities for the treatment of seasonal allergic rhinoconjunctivitis (SAR) in adults and children (1). This health problem affects as many as one in seven of the population in Western countries (2, 3), with grass pollen as one of the major triggers (4).Fundamental regulatory and technological changes are modifying the types of specific subcutaneous or sublingual SIT (SCIT and SLIT) product available to specialist practitioners. The European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have issued guidelines affecting the clinical development of SIT products (5, 6). With the exception of Gramineae grass pollen extract SLIT tablets (currently being registered across Europe as pharmaceutical specialties), SIT products are sold as either unregistered, named patient preparations or nationally registered formulations. Hence, in many European countries, the specialist physician initiating grass pollen SIT has to choose (in collaboration with the patient) between nonregistered and registered modalities. To inform that choice, we used an EBM approach to assess commercially available immunotherapy modalities.Evidence-based medicine has been defined as 'the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient' (7) and 'the integration of the best available research evidence with clinical expertise and patient values ' (8 AbstractWhen initiating grass pollen immunotherapy for seasonal allergic rhinoconjunctivitis, specialist physicians in many European countries must choose between modalities of differing pharmaceutical and regulatory status. We applied an evidence-based medicine (EBM) approach to commercially available subcutaneous and sublingual Gramineae grass pollen immunotherapies (SCIT and SLIT) by evaluating study design, populations, pollen seasons, treatment doses and durations, efficacy, quality of life, safety and compliance. After searching MEDLINE, Embase and the Cochrane Library up until January 2009, we identified 33 randomized, double-blind, placebo-controlled trials (including seven paediatric trials) with a total of 440 specific immunotherapy (SIT)-treated subjects in seven trials (0 paediatric) for SCIT with natural pollen extracts, 168 in three trials (0 paediatric) for SCIT with allergoids, 906 in 16 trials (five paediatric) for natural extract SLIT drops, 41 in two trials (one paediatric) for allergoid SLIT tablets and 1605 in five trials (two paediatric) for natural extract SLIT tablets. Trial design and quality varied significantly within and between SIT modalities. The multinational, rigorous trials of natural extract SLIT ...

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Section: Resultsmentioning

confidence: 99%

Section: Slit Grass Pollen Natural Extracts (Drops)mentioning

confidence: 99%

Towards evidence‐based medicine in specific grass pollen immunotherapy

Calderón

Mösges

Hellmich

et al. 2010

Allergy

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“…On the contrary, other works underlined the capability of SLIT with pollen allergens or with house dust mites to induce an increase of specific IgG4 (36)(37)(38)(39). Despite the lack of unanimous consent regarding the mechanism of action of SLIT, several trials have shown the efficacy of SLIT in improving symptoms in patients with allergic rhinitis and/or bronchial asthma, and with latex allergy.…”

Section: Discussionmentioning

confidence: 99%

Sublingual Desensitization in Patients with Wasp Venom Allergy: Preliminary Results

Patriarca¹,

Nucera²,

Roncallo³

et al. 2008

Int J Immunopathol Pharmacol

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The aim ofthis paper is to assess in an open prospective pilot case-control study the tolerability, safety and efficacy of an ultra-rush sublingual immunotherapy (SLIT) protocol with Vespula venom in wasp allergic patients compared to subcutaneous immunotherapy (SCIT). Forty-one wasp allergic patients were treated with sublingual (SLIT group) or subcutaneous (SCIT group) ultrarush immunotherapy with Vespula venom extract. All patients underwent skin tests and serum specific IgE and IgG 4 detection before enrolment and after 6, 12 and 24 months of immunotherapy. The SLIT group consisted of 21 (6 females and 15 males) patients who received increasing doses of Vespula venom (Aquagen, ALK-AbeIl6) until the final dose of 30 drops of extract in 3 hours, containing 100,000 SQ-U/ml. The maintenance dose was of 10 drops of pure venom extract 3 times a week, for a total dose of 100,000 SQ-U weekly (corresponding to 100 JIg of venom extract). The SCIT group consisted of 20 patients (16 males and 4 females) who were treated with subcutaneous ultrarush immunotherapy with Vespula venom extract (Pharmalgen, Alk-AbeIl6). Patients received 101.1 j..lg of Vespula venom in 3 hours and were treated with 100 ug of wasp venom monthly. During the ultrarush sublingual treatment 2 patients (9.5%) experienced mild side-effects. Specific IgE and specific IgG to wasp venom did not show any significant modification. Four patients were field-stung by a wasp during the treatment (for a total of 6 stings). Two patients (3 stings), with a previous clinical history of a grade III and IV reaction, did not experience any reaction. One patient, with a previous grade II reaction, showed a large local reaction. The fourth patient, with a previous grade III reaction, was re-stung twice (after 12 and 24 months) with two systemic reactions (SR) (mild throat constriction). During the ultrarush SCIT phase, 3 (15%) patients experienced side-effects: 2 of them showed a large local reaction and 1 had headache and stomach ache. Specific IgE showed a significant (P=O.OOI) increase after 6 months of treatment and then returned to baseline levels while specific IgG showed a significant (P=O.OOI) increase after 6, 12 and 24 months in comparison with baseline. Nine patients were field-stung during the treatment: 8 of them experienced large local reactions; one patient (11%) experienced an SR (dizziness). Our results, even if in a small number of patients, suggest that in patients with Hymenoptera sting allergy SLIT could be efficacious with a good tolerability profile when compared to SCIT. Larger studies are needed to assess efficacy, safety and tolerability profile of wasp venom SLIT.

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“…In our meta-analysis on SLIT tablets [128], data on symptom score were available in 13 RCTs [82,84,89,90,91,92,97,99,107,108,[125][126][127], and data on medication score in twelve studies [82,89,90,91,92,97,99,107,108,[125][126][127]. We excluded the Caffarelli study, because he used an allergoid, Lais [106] and Horak study because it was performed in an allergen challenge chamber [100] and the Halken study [124], which is a secondary analysis on a previously published dataset [102].…”

Section: Sublingual Immunotherapymentioning

confidence: 99%

“…The 13 RCTs included a total of 4659 patients. Seven studies were conducted in Europe [82,84,89,90,92,97,99] and five in North America [107,108,[125][126][127] and one in both Europe and Canada [91].…”

Section: Sublingual Immunotherapymentioning

confidence: 99%

Unmet Needs in Understanding Sublingual Immunotherapy to Grass Pollen

Lorenzo¹,

Leto-Barone²,

Piana³

et al. 2017

Immunotherapy - Myths, Reality, Ideas, Future

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The lack of medication for allergy symptoms at the end of the last millennium has been the promoter of the idea of treating allergies as if you were treating an infectious disease, by vaccination prophylaxis. Two forms of AIT 1) subcutaneous immunotherapy (SCIT) and 2) sublingual immunotherapy (SLIT) are used in the world. Considerable interest has emerged in SLIT both scientifically and especially financially. SLIT is not a new treatment modality. First description dates back to 1900 when H. Curtis. It was relatively widely used until the late 1970's mainly in US by homeopathic therapists.A number of case series describing experience with the oral route were published during the 1920s and 1930s, but it seems to have been perceived not as efficacious nor as well tolerated as subcutaneous immunotherapy. The companies producing allergen immunotherapy have an alliance with important opinion leaders on both shores of the Atlantic.If SLIT did not work for 40 years, why should it work for respiratory allergic diseases today? This question is the mother of all questions in the field of respiratory allergic diseases. The purpose of this chapter is to provide past and current information about immunotherapy, and discuss controversies over efficacy and safety, and dosing considerations for SLIT to grass.

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Sublingual-swallow immunotherapy with standardized 3-grass pollen extract: a double-blind, placebo-controlled study

Cited by 47 publications

References 16 publications

Towards evidence‐based medicine in specific grass pollen immunotherapy

Towards evidence‐based medicine in specific grass pollen immunotherapy

Sublingual Desensitization in Patients with Wasp Venom Allergy: Preliminary Results

Unmet Needs in Understanding Sublingual Immunotherapy to Grass Pollen

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