Effect of grass sublingual tablet immunotherapy is similar in children and adults: A Bayesian approach to design pediatric sublingual immunotherapy trials

Kaur, Amandeep; Skoner, David P.; Ibrahim, Joseph G.; Li, Qing; Lockey, Richard F.; Blaiss, Michael S.; Bufe, Albrecht; Andersen, Jens S.; Canonica, Giorgio Walter; Nolte, Hendrik

doi:10.1016/j.jaci.2017.09.051

Cited by 11 publications

(2 citation statements)

References 25 publications

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“…AIT of pollens in children aims to reduce rhinoconjunctivitis and asthma during and after AIT discontinuation. In the last years, extensive clinical trials programs performed in adults and children with sublingual tablets have allowed to establish that the effect (around 30% reduction in symptoms and medication scores) is similar in both age groups, that it is allergen‐specific, and that a vaccine with a particular allergen has no clinical effect in allergic symptoms caused by unrelated species . There is as well clinical evidence on the tolerability of two simultaneous vaccines .…”

Section: Prescribing Immunotherapy To Pollens In Children: Influencmentioning

confidence: 99%

Allergen Immunotherapy in Children User’s Guide

Alvaro‐Lozano

Akdiş

Alviani

et al. 2020

Pediatric Allergy Immunology

248

240

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Aim and scopePediatric Allergy and Immunology publishes original contributions and comprehensive reviews related to the understanding and treatment of immune defi ciency, allergic infl ammatory and infectious diseases in children. Other areas of interest include development of specifi c and accessory immunity, and the immunological interaction during pregnancy and lactation between mother and child. As the journal is intended to promote communication between scientists engaged in basic research and clinicians working with children, both clinical and experimental work will be published.

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Section: Prescribing Immunotherapy To Pollens In Children: Influencmentioning

confidence: 99%

Allergen Immunotherapy in Children User’s Guide

Alvaro‐Lozano

Akdiş

Alviani

et al. 2020

Pediatric Allergy Immunology

248

240

View full text Add to dashboard Cite

show abstract

“…In a similar way, a Bayesian design incorporating adult data could be useful for trials in HIV-infected children: by “borrowing information” from the evidence available in a completed adult trial and incorporating clinical judgement about the relevance of the adult data to the paediatric population; in this way the sample size required in a paediatric trial could be reduced55–58.…”

Section: What Other Designs Could Be Considered For Hiv-infected Chilmentioning

confidence: 99%

Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV

Ford

Turner

Turkova

et al. 2018

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Abstract:For HIV-infected children, formulation development, pharmacokinetic (PK) data, and evaluation of early toxicity are critical for licensing new antiretroviral drugs; direct evidence of efficacy in children may not be needed if acceptable safety and PK parameters are demonstrated in children. However, it is important to address questions where adult trial data cannot be extrapolated to children. In this fast-moving area, interventions need to be tailored to resource-limited settings where most HIV-infected children live and take account of decreasing numbers of younger HIV-infected children after successful prevention of mother-to-child HIV transmission. Innovative randomized controlled trial (RCT) designs enable several questions relevant to children's treatment and care to be answered within the same study. We reflect on key considerations, and, with examples, discuss the relative merits of different RCT designs for addressing multiple scientific questions including parallel multi-arm RCTs, factorial RCTs, and cross-over RCTs. We discuss inclusion of several populations (eg, untreated and pretreated children; children and adults) in “basket” trials; incorporation of secondary randomizations after enrollment and use of nested substudies (particularly PK and formulation acceptability) within large RCTs. We review the literature on trial designs across other disease areas in pediatrics and rare diseases and discuss their relevance for addressing questions relevant to HIV-infected children; we provide an example of a Bayesian trial design in prevention of mother-to-child HIV transmission and consider this approach for future pediatric trials. Finally, we discuss the relevance of these approaches to other areas, in particular, childhood tuberculosis and hepatitis.

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Sublingual Immunotherapy for Allergic Rhinitis and Asthma

Mason¹,

Rael²

2019

Allergy and Asthma

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Effect of grass sublingual tablet immunotherapy is similar in children and adults: A Bayesian approach to design pediatric sublingual immunotherapy trials

Cited by 11 publications

References 25 publications

Allergen Immunotherapy in Children User’s Guide

Allergen Immunotherapy in Children User’s Guide

Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV

Sublingual Immunotherapy for Allergic Rhinitis and Asthma

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