Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy

Bufe, Albrecht; Eberle, Peter; Franke-Beckmann, E.; Funck, J.; Kimmig, Martin; Klimek, Ludger; Knecht, Roland; Stephan, Volker; Tholstrup, Bente; Weißhaar, Christian; Kaiser, Friedrich

doi:10.1016/j.jaci.2008.10.044

Cited by 309 publications

(319 citation statements)

References 33 publications

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“…The development of sublingual tablets for pollen SIT has led to large scale clinical trials in adult 17,18 and pediatric [19][20][21] populations. These studies have confirmed the efficacy of the treatment for the first pollen season.…”

Section: Indications and Contraindicationsmentioning

confidence: 99%

Specific immunotherapy in grass pollen allergy

Mailhol

Didier²

2012

Human Vaccines & Immunotherapeutics

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Section: Indications and Contraindicationsmentioning

confidence: 99%

Specific immunotherapy in grass pollen allergy

Mailhol

Didier²

2012

Human Vaccines & Immunotherapeutics

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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%

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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“…Patients were asked to record the application of the tablet and any adverse events (AEs), and their medication, if applicable, during the first 14 days of treatment at home. The diary period was limited to the first 14 days because it is known from the controlled trials with the SQ Ò grass SLIT tablet that AE incidences are highest on day 1 of treatment and subsequently decline with proceeding treatment [4][5][6][7][8][9][10][11].…”

Section: Study Design and Treatmentmentioning

confidence: 99%

“…The standardised sublingual grass allergy immunotherapy tablet (SQ Ò grass SLIT tablet) has been developed for sublingual application in patients with grass pollen-induced rhinoconjunctivitis, and has been investigated in more than 5700 patients in controlled clinical trials in Europe and North America [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]. It has been approved Europe-wide and was launched in Germany in November 2006.…”

Section: Introductionmentioning

confidence: 99%

Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study

Schwab¹,

Wolf

Schnitker

et al. 2018

Pulm Ther

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Introduction: Intra-seasonal start of treatment with the SQ Ò grass sublingual immunotherapy (SLIT) tablet (GRAZAX Ò , ALK, Denmark) has been previously demonstrated to be well-tolerated. The objective of our study was to investigate the tolerability of intra-seasonal start of treatment comparing patients treated by allergists and general practitioners experienced in treatment of allergy (GPs). Methods: In a non-interventional, open-label, observational study, data on intra-seasonal start

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Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy

Cited by 309 publications

References 33 publications

Specific immunotherapy in grass pollen allergy

Specific immunotherapy in grass pollen allergy

Towards evidence‐based medicine in specific grass pollen immunotherapy

Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study

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