Grass pollen immunotherapy for seasonal rhinitis and asthma: A randomized, controlled trial

Walker, Samantha; Pajno, Giovanni Battista; Lima, Marcia Torres; Wilson, David E.; Durham, Stephen R.

doi:10.1067/mai.2001.112027

Cited by 258 publications

(194 citation statements)

References 20 publications

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“…Briefly, 33 subjects with severe summer hay fever were randomised into groups receiving injections of a depot grass pollen (Aquagen, ALK Abelló) vaccine (n=16), or matched placebo injections (n=17) in a rapid updosing cluster regime. Outcome measures including hay fever symptoms, use of medication, and measurement of non-specific bronchial responsiveness have been published elsewhere (Walker et al, 2001). Sera were collected during a baseline monitoring year and two years after the start of immunotherapy/placebo injections and tested in the IgE-FAB assay; results have been published elsewhere (Nouri-Aria et al, 2001).…”

Section: Assay Validation Using Results From a Clinical Trialmentioning

confidence: 99%

“…The clinical response to treatment (Walker et al, 2001) and inhibition of IgE-FAB (Nouri-Aria et al, 2004) have been previously published and are summarised in Table 3. In this evaluation of sensitivity and specificity, the combined clinical and medication scores were used to identify true positive (TP) and false positive (FP) results.…”

Section: Clinical Sensitivity and Specificitymentioning

confidence: 99%

“…We have defined the clinical sensitivity, specificity, positive predictive value, negative predictive value and the likelihood ratio of the assay. For this purpose data from a randomised double-blind placebo controlled trial of grass pollen immunotherapy (Walker et al, 2001) has been used.…”

Section: Introductionmentioning

confidence: 99%

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The IgE-facilitated allergen binding (FAB) assay: Validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses

Shamji

Wilcock

Wachholz

et al. 2006

Journal of Immunological Methods

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137

129

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The IgE-Facilitated Allergen Binding (IgE-FAB) assay represents an in vitro model of facilitated allergen presentation. Allergen-IgE complexes are incubated with an EBV-transformed B-cell line and complexes bound to CD23 on the surface of cells are detected by flow cytometry. Addition of serum from patients who have received allergen-specific immunotherapy has been shown previously to inhibit allergen-IgE complex binding to CD23 on B cells.In this study, we describe the characterisation and analytical validation of the grass pollen-specific IgE-FAB assay according to guidelines from the International Conference on Harmonisation. We established the intra and inter -assay variability of IgE-FAB and have defined the detection limits of this assay. We have also demonstrated assay linearity and robustness. Using results from a randomised double-blind placebo controlled trial of grass pollen immunotherapy (n=33), we have defined the clinical sensitivity and specificity of the IgE-FAB assay using ROC curve analysis.In conclusion, the IgE-FAB assay is reproducible, robust, sensitive and specific method suitable as a tool for monitoring inhibitory antibody function from patients receiving allergen immunotherapy.

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Section: Assay Validation Using Results From a Clinical Trialmentioning

confidence: 99%

Section: Clinical Sensitivity and Specificitymentioning

confidence: 99%

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The IgE-facilitated allergen binding (FAB) assay: Validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses

Shamji

Wilcock

Wachholz

et al. 2006

Journal of Immunological Methods

Self Cite

137

129

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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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“…SIT has been shown to be a robust and clinically effective approach [1,2], improving the quality of life of the treated individuals, through the reduction of symptoms and medication usage [3].…”

Section: Introductionmentioning

confidence: 99%

Allergen immunotherapy with nanoparticles containing lipopolysaccharide from Brucella ovis

Gómez

Gamazo

Román

et al. 2008

European Journal of Pharmaceutics and Biopharmaceutics

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Background: Specific immunotherapy implies certain drawbacks which could be minimized by the use of good adjuvants, capable of amplifying the appropriate immune response with minimal adverse effects.Objective: To evaluate the adjuvant capacity of the association of the rough lipopolysaccharide of Brucella ovis with Gantrez ® AN nanoparticles.Methods: Ovalbumin (allergen model)-containing Gantrez ® AN nanoparticles with either encapsulated or coated lipopolysaccharide were prepared and administered intradermally to BALB/c mice in order to evaluate the immune response. Pre-sensitized BALB/c mice were also administered with the formulations and they were challenged with an intraperitoneal injection of ovalbumin. Anaphylactic symptoms, including mortality rates, were evaluated after the challenge.

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Grass pollen immunotherapy for seasonal rhinitis and asthma: A randomized, controlled trial

Cited by 258 publications

References 20 publications

The IgE-facilitated allergen binding (FAB) assay: Validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses

The IgE-facilitated allergen binding (FAB) assay: Validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses

Towards evidence‐based medicine in specific grass pollen immunotherapy

Allergen immunotherapy with nanoparticles containing lipopolysaccharide from Brucella ovis

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