Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy.

BACKGROUND: No approved treatment for peanut allergy exists for children younger than 4 years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown. METHODS: We conducted this phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo. RESULTS: Of the 362 patients who underwent randomization, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P<0.001). Adverse events that occurred during the use of the intervention or placebo, irrespective of relatedness, were observed in 100% of the patients in the intervention group and 99.2% in the placebo group. Serious adverse events occurred in 8.6% of the patients in the intervention group and 2.5% of those in the placebo group; anaphylaxis occurred in 7.8% and 3.4%, respectively. Serious treatment-related adverse events occurred in 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group. CONCLUSIONS: In this trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy for 12 months was superior to placebo in desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms. (Funded by DBV Technologies; EPITOPE ClinicalTrials.gov number, NCT03211247.).

Site-specific, covalent incorporation of Tus, a DNA-binding protein, on ionic-complementary self-assembling peptide hydrogels using transpeptidase Sortase A as a conjugation tool†Dedicated to the memory of Joachim H. G. Steinke.‡Electronic supplementary information (ESI) available: Further experimental data. See DOI: 10.1039/c3sm00131hClick here for additional data file.

The site-specific conjugation of DNA-binding protein (Tus) to self-assembling peptide FEFEFKFKK was demonstrated. Rheology studies and TEM of the corresponding hydrogels (including PNIPAAm-containing systems) showed no significant variation in properties and hydrogel morphology compared to FEFEFKFKK. Critically, we demonstrate that Tus is accessible within the gel network displaying DNA-binding properties.

Intranasal antihistamines for allergic rhinitis: examining the clinical impact.

Allergic rhinitis is likely the most common medical complaint to a clinical allergist and immunologist affecting between 10 and 30% of all adults. This disease causes significant impact on quality of life as well as creating a financial burden on society with decreased work productivity and medication costs. Often, many allergy sufferers do not adhere to the medication recommendations provided by their physician most often because these therapies have not provided relief. Although in the past, the mainstay of treatment for allergic rhinitis has been environmental avoidance, immunotherapy, nasal corticosteroids, and oral antihistamines, the most recent rhinitis diagnosis parameters published by the American Academy of Allergy, Asthma and Immunology have also discussed the importance of other often overlooked therapies. More specifically, the new guidelines discuss a place for the use of intranasal antihistamines as first-line therapy as well as potentially providing superior relief to second-generation oral antihistamines. The guidelines also identify the biphasic nature of the allergic response with both phases consisting of nasal pruritus, sneezing, rhinorrhea, and congestion with the late phase predominated by nasal congestion. It is important to understand how intranasal antihistamines fit into these latest guidelines as first-line therapy and to understand how they may be beneficial to the symptoms associated with allergic rhinitis. It is equally important to identify the individuals who have had less success with their current therapies to determine if intranasal antihistamines would be an important adjunct in therapy.