Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis. A Phase 3 Randomized Clinical Trial

Original Investigation

Eric L. Simpson, MD¹; Amy S. Paller, MS, MD^2,3; Elaine C. Siegfried, MD⁴; et alMark Boguniewicz, MD⁵; Lawrence Sher, MD⁶; Melinda J. Gooderham, MD^7,8,9; Lisa A. Beck, MD¹⁰; Emma Guttman-Yassky, MD, PhD^11,12,13; David Pariser, MD¹⁴; Andrew Blauvelt, MD, MBA¹⁵; Jamie Weisman, MD¹⁶; Benjamin Lockshin, MD^17,18; Thomas Hultsch, MD¹⁹; Qin Zhang, PhD²⁰; Mohamed A. Kamal, PharmD, PhD²⁰; John D. Davis, PhD²⁰; Bolanle Akinlade, MD, MBA²⁰; Heribert Staudinger, MD, PhD²¹; Jennifer D. Hamilton, PhD²⁰; Neil M. H. Graham, MBBS, MD, MPH²⁰; Gianluca Pirozzi, MD, PhD²¹; Abhijit Gadkari, PhD²⁰; Laurent Eckert, PhD²²; Neil Stahl, PhD²⁰; George D. Yancopoulos, MD, PhD²⁰; Marcella Ruddy, MD²⁰; Ashish Bansal, MD²⁰

Author Affiliations Article Information

JAMA Dermatol. Published online November 6, 2019. doi: https://doi.org/10.1001/jamadermatol.2019.3336

Key Points

Question  What is the efficacy and safety of dupilumab monotherapy in adolescents with moderate to severe inadequately controlled atopic dermatitis?

Findings  In this randomized phase 3 clinical trial including 251 adolescents with moderate to severe atopic dermatitis, dupilumab 200 or 300 mg every 2 weeks and 300 mg every 4 weeks resulted in a significant treatment response vs placebo following 16-week treatment, with an acceptable safety profile.

Mechanism(s) of prolonged attenuation of allergic responses after modulation of idiotypic regulatory network

• Allergy, Asthma & Clinical Immunology Research
• Open Access
• 
  

• R. M. Gorczynski, 
• T. Maqbool & 
• G. Hoffmann 

Allergy, Asthma & Clinical Immunology volume 15, Article number: 79 (2019) 

• details

Abstract

Background

We showed previously that allergic reactivity to ovalbumin (OVA) could be regulated in mice following perturbation of immune networks using combinations of an immune Ig along with anti-idiotypic Ig. We have explored features of this regulation including: its persistence after cessation of administration of combined Igs; the ability of heterologous Igs to produce immunoregulation; a role for Treg induction in regulation; and the ability to attenuate responses in mice pre-sensitized to an allergic stimulus.

CME / ABIM MOC

Virtual Case Challenges: Inflammatory Skin Conditions and Comorbid Allergies 

• Authors: Jonathan I. Silverberg, MD, PhD, MPH; Jonathan Spergel, MD, PhD
• CME / ABIM MOC Released: 11/22/2019
• Valid for credit through: 11/22/2020

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Efficacy and Safety of Twice-daily and Once-daily Olopatadine-Mometasone Combination Nasal Spray for Seasonal Allergic Rhinitis

Open Access

Charles P. Andrews, MD1,∗,Correspondence information about the author MD Charles P. AndrewsEmail the author MD Charles P. Andrews

, 

Dale Mohar, MD2

, 

Yacine Salhi, PhD3

, 

Sudeesh K. Tantry, PhD3

DOI: https://doi.org/10.1016/j.anai.2019.11.007

Article Info

• Abstract

• Full Text
• Images
• References

ABSTRACT

BACKGROUND

GSP301 is an investigational fixed-dose combination nasal spray of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).

OBJECTIVE

To evaluate efficacy and safety of GSP301 in patients with seasonal AR (SAR).

METHODS

In this phase 2, double-blind, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to twice-daily GSP301 (olopatadine 665μg and mometasone 25μg), once-daily GSP301 (olopatadine 665μg and mometasone 50μg), twice-daily or once-daily olopatadine monotherapy (665μg), mometasone monotherapy (twice-daily 25μg or once-daily 50μg), or placebo for 14 days.

30 Years Of Sublingual Immunotherapy

REVIEW ARTICLE
Free Access

Giovanni Passalacqua , Diego Bagnasco , Giorgio Walter Canonica
https://doi.org/10.1111/all.14113

Abstract

Allergen Immunotherapy (AIT) was introduced in clinical practice on an empirical basis more than 100 years ago. Since the first attempts, AIT was administered subcutaneously. Indeed, other routes of administration were proposed and studied, in particular to improve the safety, but only the sublingual route (SLIT) achieved a credibility based on evidence, and was then accepted as a viable “alternative” option to the subcutaneous route. SLIT was largely used in clinical trials and clinical practice in this last 30 years. Thus, a large amount of data is available, coming from either controlled trials and post‐marketing surveillance studies.

Does unified allergic airway disease impact on lung function and type 2 biomarkers?

• Letter to the editor
• Open Access
• Allergy, Asthma & Clinical Immunology

• Chris RuiWen Kuo, 
• Rory Chan & 
• Brian Lipworth 

Allergy, Asthma & Clinical Immunology volume 15, Article number: 75 (2019) 

• details

Abstract

Values are shown as means and standard error of means
for significant comparisons between allergic asthma with and without
allergic rhinitis according to a FEV1% predicted,
b FEF25–75% predicted, c FeNO and d blood eosinophils

The concept of the unified allergic airway disease (UAD) recognises the association between allergic inflammation in the upper and lower airways. Patients with asthma and concomitant allergic rhinitis experience more asthma-related primary and secondary care visits. We therefore aimed to determine differences in asthma control (asthma control questionnaire ACQ-6), lung function (spirometry) and T2 biomarkers (FeNO and Eos) in relation to the presence of allergic rhinitis in patients with allergic asthma.

Short-term skin problems in infants aged 0–3 months affect food allergies or atopic dermatitis until 2 years of age, among infants of the general population

• Research
• Open Access
• 
  

Allergy, Asthma & Clinical Immunology

• Kaori Yonezawa & 
• Megumi Haruna 

Allergy, Asthma & Clinical Immunology volume 15, Article number: 74 (2019) 

Abstract

Background

This study examined whether infants aged 0–3 months exhibited long-term effects of using a moisturizer skincare intervention and whether a short-term skin problem resulted in the subsequent development of food allergies or atopic dermatitis (AD) until the age of 2 years.

The International/Canadian Hereditary Angioedema Guideline

• Review
• Open Access

Allergy, Asthma & Clinical Immunology

Stephen Betschel, 

Jacquie Badiou, 

[…]

Ellie Tsai 

Allergy, Asthma & Clinical Immunology volume 15, Article number: 72 (2019) 

• details

Abstract

This is an update to the 2014 Canadian Hereditary Angioedema Guideline with an expanded scope to include the management of hereditary angioedema (HAE) patients worldwide. It is a collaboration of Canadian and international HAE experts and patient groups led by the Canadian Hereditary Angioedema Network. The objective of this guideline is to provide evidence-based recommendations, using the GRADE system, for the management of patients with HAE.

Agreement between self-reported asthma symptoms and exhaled nitric oxide levels: impact on inhaled corticosteroid prescribing in general practice. An observational study

• Research
• Open Access

Allergy, Asthma & Clinical Immunology

• Raj Gill & 
• E. Mark Williams 

Allergy, Asthma & Clinical Immunology volume 15, Article number: 70 (2019) 

Abstract

Background

A box-plot of FeNO levels. The median is shown with 25–75th percentile.
An outlier of 279 is included in the analysis but not shown

The National Review of Asthma Deaths UK highlighted that 46% of deaths could be avoided and recommended that all sufferers receive a structured asthma annual review which assess asthma control. In primary care this is commonly achieved using symptom-based questionnaires such as the Asthma Control Test (ACT). A newer method of assessing asthma control is Fractional Exhaled Nitric Oxide (FeNO) testing, which is currently recommended for the diagnosis of asthma, but not for monitoring of asthma control.

Immunostimulants in respiratory diseases: focus on Pidotimod

Multidisciplinary Respiratory Medicine

• Francesca Puggioni, 
• Magna Alves-Correia, 
• Manar-Farouk Mohamed, 
• Niccolò Stomeo, 
• Riccardo Mager, 
• Massimiliano Marinoni, 
• Francesca Racca, 
• Giovanni Paoletti, 
• Gilda Varricchi, 
• Veronica Giorgis, 
• Giovanni Melioli, 
• Giorgio Walter Canonica & 
• Enrico Heffler 

Multidisciplinary Respiratory Medicine volume 14, Article number: 31 (2019)

Abstract

Immunological activities of Pidotimod

Usefulness of Pidotimod and its role as immunostimulant, has been discussed, we know, for several decades. Nevertheless, there is still much to know. Understanding its mechanisms and its potential usefulness in airway infections and its prevention, asthma both Th2 and non Th2 type, bronchiectasis, as adjuvant in vaccination and in allergen immunotherapy still remains to clearly unveil. The aim of this paper was to provide a useful updated review of the role of the main available immunostimulants, giving particular focus on Pidotimod use and its potentials utility in respiratory diseases.

Adherence to adrenaline autoinjector prescriptions in patients with anaphylaxis

• Research Letter
• Open Access
• 
  

Clinical and Translational Allergy

• Louise Parke, 
• Annemarie Schaeffer Senders, 
• Carsten Bindslev-Jensen, 
• Annmarie Touborg Lassen, 
• Athamaica Ruiz Oropeza, 
• Susanne Halken, 
• Sigurd Broesby-Olsen, 
• Henrik Fomsgaard Kjær & 
• Charlotte G. Mortz 

Clinical and Translational Allergy volume 9, Article number: 59 (2019) 

• details

Percentage of retrieved adrenaline autoinjectors
in relation to age

Abstract

This study evaluates adherence to adrenaline autoinjector prescriptions in a cohort of well-characterized anaphylaxis patients. The overall retrieval rate was 76% with the highest rate in patients with severe anaphylaxis. Special attention is needed in patients with unknown elicitors and in young adults, comprising the largest proportion of non-adherent patients.

Trial registration No intervention performed. Retrospective data used with permission from the Danish Data Protection Agency and Regional Committees on Health Research Ethics.

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