Safety Of A Sublingual Tablet of House Dust Mite Allergen Extracts In An Environmental Exposure Chamber Study
Poster Mar 09, 2015
Michel Roux, Agnès Viatte, Robert K. Zeldin
Rationale: The efficacy of house dust mite (HDM) sublingual tablets was demonstrated in an environmental exposure chamber (EEC) study of patients with allergic rhinitis upon exposure to HDM allergens. Here we report the safety results.
Methods: Adults (18–55 years) with medically confirmed HDM-associated allergic rhinitis were randomized in this DBPC study to receive 500IR, 300IR or 100IR HDM tablet or placebo daily for 6 months. Patients with intermittent asthma were eligible. Participants were exposed to five 4-hour allergen challenges in the EEC (baseline, treatment months 1, 2, 4, 6). Adverse events (AE) were monitored throughout the study and analyzed descriptively. All patients receiving at least one dose of the investigational product were included in the safety set.
Results: 355 patients (safety set: 500IR=93, 300IR=86, 100IR=89 and Placebo=87) were randomized. 94% (500IR), 91% (300IR), 97% (100IR) and 83% (Placebo) reported at least one AE on treatment. Application site reactions were the most commonly reported AEs (500IR=74%, 300IR=70%, 100IR=69%, and Placebo=37%). The incidence of asthma and related symptoms was higher during the peri-EEC challenge periods (i.e., the day of and the day after challenge; range: 37%-45%) than outside these periods (16%-21%) but was similar across treatment groups. No anaphylaxis or serious drug-related AEs were reported. 20 patients withdrew due to a TEAE, mostly due to application site reactions.
Conclusions: Treatment with HDM sublingual tablets was generally well tolerated regardless of dose. While asthma and related symptoms were more common during the peri-EEC challenge periods, rates did not differ between active and placebo treatment.
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Genome-wide association studies (GWAS) have identified more than 100 genetic loci associated with type 2 diabetes. The majority of these are located in the intergenic or intragenic regions suggesting that the implicated variants may alter chromatin conformation. This, in turn, is likely to influence the expression of nearby or more remotely located genes to alter beta cell function. At present, however, detailed molecular and functional analyses are still lacking for most of these variants. We recently analysed one of these loci and mapped five causal variants in an islet-specific enhancer cluster within the STARD10 gene locus. Here, we aimed to understand how these causal variants influence b-cell function by alteration of the chromatin structure of enhancer clusterREAD MORE
Treatment Options for Chronic Parvovirus Viremia in Pediatric Heart Transplant Patients in a Tertiary Care CenterPoster
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T-helper cell phenotype expression in cutaneous lesions of angioimmunoblastic T-cell lymphomaPoster
Angioimmunoblastic T-cell lymphoma (AITL) is a common type of peripheral T-cell lymphoma. AITL can be missed until lymphadenopathy develops in patients initially presenting with skin lesions, as skin biopsy may lack conclusive findings. Our case highlights the extranodal presentation of AITL with cutaneous lesions displaying the TFH phenotype.READ MORE