Background: The summary of product characteristics of the grass allergy immunotherapy tablet (AIT) (Phleum pratense grass pollen allergen extract) states that clinical effect may be observed in the first pollen season of treatment, if treatment is initiated ≥2 months (8 weeks) before the start of the grass pollen season. However, because patients with grass allergy may first present to physicians during the season, immediate treatment initiation (ie, in-season initiation) may increase treatment compliance and reduce the risk for disease progression compared with asking patients to return before the next pollen season to initiate treatment. This "in-season approach" may offer more patients the potentially beneficial treatment option of specific immunotherapy. However, to date, the immunomodulatory effects and tolerability of in-season treatment initiation is unknown.
Objective: The aim of this study was to assess the immunologic effects and tolerability of in-season initiation of treatment with the grass AIT.
Methods: This multicenter, randomized, double-blind, placebo-controlled trial was carried out in Germany and Austria. Adults with grass pollen allergy (positive skin-prick test and specific grass-pollen immunoglobulin [Ig] E) and grass pollen-induced moderate to severe persistent rhinoconjunctivitis were enrolled. Patients were randomly assigned to receive once-daily grass AIT or placebo, starting during the 2008 grass pollen season and continuing for 8 to 10 weeks. The primary end point was change from baseline in IgE-blocking factor (serum components competing with IgE for allergen binding). Secondary end points included changes from baseline in specific IgE and IgG(4) and measures of tolerability (assessed mainly by adverse events [AEs]). Blood samples for immunologic assessment were obtained by the investigators at baseline and after treatment. All AEs observed by the investigator and/or reported by the patient were recorded throughout the trial and follow-up.
Results: A total of 276 patients were enrolled and formed the full analysis set (mean age, 35 years; 55% men, 45% women; 99% white; mean weight, 76 kg; history of asthma, 41%; mean duration of grass allergy, 15.1 years). No major differences in medical history were found between the grass AIT group (n = 219) and the placebo group (n = 57). The change from baseline in mean concentration of IgE-blocking factor was significantly greater with grass AIT compared with placebo (+0.14 vs +0.05; P < 0.0001). The changes from baseline in specific IgE and specific IgG(4) concentrations were significantly greater with AIT compared with placebo (IgE, +0.59 vs +0.21 log kU/L; IgG(4), +0.18 vs +0.04 log relative units; both, P < 0.0001). At least 1 AE was reported in 58% of patients in the AIT group and in 40% of patients in the placebo group. Most AEs considered related to AIT were mild or moderate events in the mouth, throat, and/or ears (eg, oral pruritus). Four serious AEs were reported in the AIT group (sinusitis, road traffic accident, salmonellosis, meniscus lesion), but all were considered unlikely to be related to treatment. Three percent of the grass AIT group and 2% of the placebo group were withdrawn from the trial due to an AE.
Conclusions: In-season initiation of grass AIT was associated with an immunomodulatory response in terms of induction of IgE-blocking factor, specific IgE, and specific IgG(4). In-season initiation of grass AIT was generally well tolerated in this group of adults with moderate to severe grass pollen-induced rhinoconjunctivitis. These findings are consistent with those related to the preseasonal initiation of AIT therapy.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.clinthera.2011.06.006 | DOI Listing |
Rhinology
December 2024
Center of Allergy and Environment (ZAUM), Technical University of Munich and Helmholtz Center Munich, German Research Center for Environmental Health, Germany, Member of the German Center for Lung Research (DZL), Munich, Germany and Member of the Helmholtz I and I Initiative.
Background: Allergen-specific immunotherapy (AIT) is a disease-modifying therapy and is effective to reduce the symptoms of grass pollen-allergy. The airway epithelium of these patients releases inflammatory mediators including type-2 cytokines, which are associated with cellular processes involved in the symptomatic response of the affected tissue. Aim of the study was to identify epithelial biomarkers indicating AIT progress.
View Article and Find Full Text PDFEnviron Monit Assess
November 2024
Agricultural Systems and Engineering, Department of Food, Agriculture and Bioresources, School of Environment, Resources and Development, Asian Institute of Technology, Klong Luang, Pathum Thani, 12120, Thailand.
The lower Chao Phraya River Basin (CPRB) in Thailand, a major rice-producing area, is grappling with increased water scarcity alongside more frequent floods and droughts, necessitating effective adaptation strategies to sustain agricultural productivity. This study assesses the impacts of climate change on rice yield and irrigation water use, using the DSSAT-CERES-Rice model. Based on these findings, potential genotype- and management-based adaptation strategies were recommended.
View Article and Find Full Text PDFWorld Allergy Organ J
November 2024
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
Background: In the realm of allergen immunotherapy (AIT), the quality of evidence varies across different products, making it unjustifiable to extend overall conclusions to all AIT products, as highlighted by WAO and EAACI.
Objective: To confirm the efficacy of the 300 IR 5-grass pollen sublingual AIT (SLIT)-tablet through a specific meta-analysis of randomized controlled trials (RCTs) involving patients with allergic rhino-conjunctivitis (ARC) with/without mild/intermittent asthma.
Methods: Data from published RCTs on the 300 IR 5-grass SLIT-tablet were gathered from electronic databases (MEDLINE, ISI Web of Science, LILACS, the Cochrane Library and ClinicalTrial.
Allergy
December 2024
Allergopharma GmbH & Co, Reinbek, Germany.
Background: Natural allergen sources contain a variety of allergens, against which allergic subjects have developed individual sensitization profiles. Ideal allergen products for skin prick testing (SPT) and allergen immunotherapy (AIT) should contain the complete set of allergens of the respective allergen sources to cover all sensitization profiles. However, commercially available allergen products were shown to vary regarding their allergen composition.
View Article and Find Full Text PDFCurr Opin Allergy Clin Immunol
December 2024
Servicio de Alergia, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) Madrid, Spain. University of Alcalá (UAH).
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!