Safety of the SQ tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials

Background The standardized quality (SQ) tree sublingual immunotherapy (SLIT)-tablet has recently been approved for treatment of tree pollen allergy. Healthcare workers should be provided with detailed safety data for clinical use. Objective To assess the tolerability and safety of the SQ tree SLIT-tablet (12 SQ-Bet) in adults and adolescents. Methods Safety data were pooled from three double-blinded, randomized, placebo-controlled trials (2 phase-II/1 phase-III) including adults and adolescents 12-65 years with allergic rhinitis and/or conjunctivitis treated before and during one pollen season once-daily with 12 SQ-Bet (n = 471) or placebo (n = 458): EudraCT no: 2012-000031-59; NCT02481856; EudraCT 2015-004821-15. Results The most frequently reported investigational medicinal product (IMP)-related AEs with 12 SQ-Bet were oral pruritis (39% of subjects) and throat irritation (29%). IMP-related AEs were mainly mild or moderate in severity, and the majority resolved without treatment and did not lead to treatment interruption/discontinuation. With 12 SQ-Bet, oral pruritus was more frequent among subjects with pollen food syndrome (PFS) (45%) than without PFS (29%). The 12 SQ-Bet did not seem to induce an increased risk of asthma: 7 events were reported in 7 subjects with 12 SQ-Bet and 11 in 10 subjects with placebo. No differences were seen in the risk of moderate-to-severe IMP-related AEs regardless of age, PFS status and asthma medical history. Conclusions The 12 SQ tree SLIT-tablet was well tolerated in tree pollen allergic subjects with no major safety concerns detected. This safety profile supports daily at-home sublingual administration once the first dose is tolerated when administered under medical supervision.Peer reviewe

Fel d 1–derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study

BackgroundAllergic rhinoconjunctivitis is an increasingly common source of morbidity, with sensitivity to cats accounting for 10% to 15% of disease burden. Allergy to cats is also a major risk factor for the development of asthma.ObjectivesWe sought to probe the persistence of the treatment effect of a novel Fel d 1–derived peptide antigen desensitization (Cat-PAD) 1 year after the start of treatment in subjects with cat allergy–induced rhinoconjunctivitis after standardized allergen challenge.MethodsIn a randomized, double-blind, placebo-controlled, parallel-group clinical trial, subjects attended an environmental exposure chamber in which they were exposed to cat allergen before and after treatment with 2 different regimens of Cat-PAD over a 3-month period. Clinical efficacy was assessed as a change in total rhinoconjunctivitis symptom scores 18 to 22 weeks and 50 to 54 weeks after the start of treatment.ResultsTreatment with Cat-PAD showed greater efficacy with 4 administrations of a 6-nmol dose 4 weeks apart than with 8 administrations of a 3-nmol dose 2 weeks apart. The treatment effect of 6 nmol persisted 1 year after the start of treatment and was significantly different from that of 3 nmol (P = .0342) and placebo (P = .0104). The treatment effect was apparent on both nasal and ocular symptoms at 1 year.ConclusionsA short course of Cat-PAD improves the ocular and nasal components of rhinoconjunctivitis symptoms in subjects with cat allergy, with the treatment effect persisting 1 year after the start of treatment

An update on molecular cat allergens: Fel d 1 and what else? Chapter 1: Fel d 1, the major cat allergen

Background: Cats are the major source of indoor inhalant allergens after house dust mites. The global incidence of cat allergies is rising sharply, posing a major public health problem. Ten cat allergens have been identified. The major allergen responsible for symptoms is Fel d 1, a secretoglobin and not a lipocalin, making the cat a special case among mammals. Main body: Given its clinical predominance, it is essential to have a good knowledge of this allergenic fraction, including its basic structure, to understand the new exciting diagnostic and therapeutic applications currently in development. The recent arrival of the component-resolved diagnosis, which uses molecular allergens, represents a unique opportunity to improve our understanding of the disease. Recombinant Fel d 1 is now available for in vitro diagnosis by the anti-Fel d 1 specific IgE assay. The first part of the review will seek to describe the recent advances related to Fel d 1 in terms of positive diagnosis and assessment of disease severity. In daily practice, anti-Fel d 1 IgE tend to replace those directed against the overall extract but is this attitude justified? We will look at the most recent arguments to try to answer this question. In parallel, a second revolution is taking place thanks to molecular engineering, which has allowed the development of various forms of recombinant Fel d 1 and which seeks to modify the immunomodulatory properties of the molecule and thus the clinical history of the disease via various modalities of anti-Fel d 1-specific immunotherapy. We will endeavor to give a clear and practical overview of all these trends

Regard sur quatre créateurs

À travers ces quatre textes, le pianiste Marc Couroux présente un portrait d’autant de créateurs chez qui, selon lui, la notion d’identités canadienne et québécoise est primordiale et intégrée à l’acte de création. Il situe les quatre compositeurs par rapport aux enjeux historiques de la création québécoise, tout en soulignant les particularités de l’esthétique de chacun d’entre eux.With these four texts, pianist Marc Couroux presents a portrait of four composers for whom, according to him, the notion of Canadian and Quebecois identity is of primordial importance and integrated within the creative act. He situates them with respect to significant moments in the history of Quebec concert music, while pointing out particularities within the aesthetics of each

Dompter la mer sauvage : Réflexions sur Evryali de Iannis Xenakis

Cet article fait état de la problématique des interprètes confrontés à des oeuvres « irréalisables » dans leur intégrité. La question est abordée sous les angles de la technique, de l’esthétique et de l’éthique. Face à diverses solutions proposées, l’interprète doit définir ses choix en s’appuyant sur une analyse de l’oeuvre qui lui permette d’en retrouver le sens.The problems which performers confront with "unplayable" works, especially Xenakis's Evryali for piano, are examined from technical, aesthetical and ethical perspectives. Faced with diverse possible solutions, a performer must define his choices by relying upon an analysis which truly facilitates meaning

Neighbor-stranger discrimination and individual recognition by voice in the American redstart (Setophaga ruticilla)

This research examined how song is used to transmit information on individual identity in American redstarts (Setophaga ruticilla). Specifically, it attempted to determine whether American redstarts (1) discriminate between neighbors and strangers on the basis of their respective songs, and (2) recognize individuals by their distinctive voice characteristics. I tested the latter by exposing subjects to identical song types sung by different birds. Each subject's behavior was evaluated according to a variety of response variables. In all trials, for all response variables, subjects responded highly but equally to each of the songs played. A post-hoc analysis revealed that the order in which treatment songs were presented affected the birds' responses. For four of five response variables, subjects successfully distinguished between the songs of neighbors and strangers when played the fourth song in the trial. Thus, it would appear that in redstarts this type of discrimination may be observed only after an initial song-exposure period

Some Ideas about Viewer Re-Mobilization from a Practice-in-Progress

This article presents a practical view of one artist's dealings with the social and political aspects of the concert, seen through a variety of works realized between 1999 and 2006. Couroux's work is centered around the reintegration of the listener-viewer into the social event, specifically the concert format, which has functioned as a control group, enabling him to test some ideas about viewer mobilization. Exploring the potential of art as a motor for social investigation, he exploits the perceptual and cultural prejudices of the viewer to create a productive, creative zone of inquiry. A brief history of anti-virtuosity begins the article (with examples from Xenakis, Barrett, Ferneyhough and Glenn Gould, all of whom have called into question in various ways the totalized persona of the performer), ushering in the feedback processes of his work American Dreaming and the anti-absorptive strategies which underlie le contrepoint académique (sic). Finally, the position of the listener is problematized in two works: Blowback at Breakfast, in which he/she is enmeshed in a panopticon-like voyeuristic bind with the performer, and Watergating, in which shifting modes of aurality force a deconstruction of the listening process itself.Cet article fait état d’un regard pratique posé par un artiste composant avec les aspects sociaux et politiques du concert, à travers un certain nombre d’oeuvres réalisées entre 1999 et 2006. Le travail de Couroux se concentre sur la réintégration de l’auditeur-spectateur dans un événement social, plus spécifiquement le cadre du concert, qu’il utilise comme groupe témoin lui permettant de mettre à l’épreuve ses idées sur la mobilisation du spectateur. Explorant le potentiel de l’art en tant que moteur d’investigation sociale, il exploite les préjugés à la fois perceptuels et culturels qu’entretient le spectateur, dans le but de créer un environnement de recherche productif et créateur. L’article débute par un bref historique de l’anti-virtuosité (avec des références à Xenakis, Barrett, Ferneyhough et Gould, chacun ayant remis en question, de diverses façons, la figure de l’interprète), introduisant les processus de feedback de son oeuvre American Dreaming et les statégies anti-absorptives qui sous-tendent le contrepoint académique (sic). Enfin, la position de l’auditeur est problématisée dans deux oeuvres : Blowback at Breakfast, dans lequel l’auditeur est relié à l’interprète par un voyeurisme quasi panoptique, et Watergating, dans lequel les nombreux changements de modes d’oralité obligent à la déconstruction du processus d’écoute

Spatially-based fiscal impact analysis: an integrated approach to urban growth management

Bibliography: p. 108-113Some pages are in colour