Epicutaneous Immunotherapy (EPIT) Is Effective and Safe to Treat Peanut Allergy: A Multi-National Double-Blind Placebo-Controlled Randomized Phase IIb Trial

Sampson, Hugh A.; Agbotounou, Wence; Thébault, Claude; Ruban, Charles; Martin, Laurent; Yang, William H.; Sussman, Gordon; Brown-Whitehorn, Terri F.; Nadeau, Kari; Cheema, Amarjit; Leonard, Stephanie A.; Pongracic, Jacqueline A.; Sauvage, C.; Assa’ad, Amal; Blay, F. De; Bird, J. Andrew; Tilles, Stephen A.; Boralévi, F.; Bourrier, T.; Shreffler, Wayne G.; Hébert, Jacques; Green, Todd David; Wijk, Roy Gerth van; Knulst, André C.; Kanny, G.; Kowalski, Marek L.; Schneider, Lynda C.; Benhamou, Pierre-Henri; Dupont, Christophe

doi:10.1016/j.jaci.2014.12.1901

Cited by 28 publications

(13 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, the Viaskin ® EDS was demonstrated as a sensitive tool for the diagnosis of cow's milk [13] and house dust mites [33] allergy in children, for which it is in clinical use in France. Encouraging results have been collected for its use in epicutaneous immunotherapy (EPIT) [15,18,19], and the safety and efficacy of Viaskin ® -mediated EPIT against peanut allergy was demonstrated in a recent phase IIb clinical trial [34].…”

Section: Discussionmentioning

confidence: 99%

Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: Preclinical proof of concept

Gavillet

Mondoulet

Dhelft

et al. 2015

Vaccine

View full text Add to dashboard Cite

The limited durability of pertussis vaccine-induced protection requires novel approaches to reactivate immunity and limit pertussis resurgence in older children and adults. We propose that periodic boosters could be delivered using a novel epicutaneous delivery system (Viaskin) to deliver optimized pertussis antigens such as genetically-detoxified pertussis toxin (rPT). To best mimic the human situation in which vaccine-induced memory cells persist, whereas antibodies wane, we developed a novel adoptive transfer murine model of pertussis immunity. This allowed demonstrating that a single application of Viaskin delivering rPT and/or pertactin and filamentous hemagglutinin effectively reactivates vaccine-induced pertussis immunity and protects against Bordetella pertussis challenge. Recalling pertussis immunity without needles nor adjuvant may considerably facilitate the acceptance and application of periodic boosters.

show abstract

Section: Discussionmentioning

confidence: 99%

Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: Preclinical proof of concept

Gavillet

Mondoulet

Dhelft

et al. 2015

Vaccine

View full text Add to dashboard Cite

show abstract

“…In the Viaskin Peanut’s Efficacy and Safety (VIPES) study, 221 subjects 6–55 years of age were randomized to a 50 μg peanut patch, a 100 μg patch, a 250 μg patch, or placebo for 12 months. The most effective response was seen in the 250 μg patch group who exhibited a 50 % response rate (defined as the ability to tolerate 1000 mg of peanut protein or a 10-fold increase in eliciting dose of peanut protein during challenge compared to baseline) vs. 25 % in the placebo group ( p = 0.0108) [14]. One hundred and seventy-one of the subjects in the original trial are now being treated in an open-label extension of the study for an additional 24 months.…”

Section: Methods Of Immunotherapymentioning

confidence: 99%

“…These local skin reactions were mostly mild to moderate in severity and resolved over time. Less than 1 % of subjects dropped out due to severe dermatitis [14]. …”

Section: Side Effects and Adverse Eventsmentioning

confidence: 99%

Desensitization for Peanut Allergies in Children

Jhamnani

Frischmeyer‐Guerrerio

2016

Curr Treat Options Allergy

View full text Add to dashboard Cite

Opinion Statement Immunotherapy for peanut allergy has been an exploding topic of study within the last few years. Sublingual, epicutaneous, and oral immunotherapy are being investigated and show promise in the treatment of peanut allergy. Oral immunotherapy has shown the most clinical benefit; however, sublingual and epicutaneous immunotherapy appear to have the most favorable safety profiles. Most studies to date suggest that only a minority of subjects achieve sustained unresponsiveness to peanut after discontinuation of immunotherapy. Recent efforts have been focused on identifying adjunct therapies, such as omalizumab, that may assist patients in achieving peanut desensitization more quickly and with greater success. Several underlying immunologic mechanisms, including a switch from IgE to IgG4 production and induction of T regulatory cells, have been studied although more research is needed to identify reliable biomarkers. This article will describe the immunotherapy approaches that are being investigated to induce peanut desensitization, and highlight the benefits and risks of these therapies that need to be considered before they are ready for routine clinical practice.

show abstract

“…Both concluded that EPIT was safe, effective, and well tolerated with high adherence rate. Sampson et al [27] randomized 221 6-55-year-old patients to placebo or 50,100,250 micrograms peanut protein patches for 52 weeks. All three treatment groups met their primary endpoints with largest effect noted in 250 μg group (cumulative dose +1121 mg).…”

Section: Epicutaneous Immunotherapymentioning

confidence: 99%

Emerging Approaches to Food Desensitization in Children

Hamad

Burks

2017

Curr Allergy Asthma Rep

View full text Add to dashboard Cite

Recent advancements in epicutaneous, sublingual, and oral immunotherapy for food allergy in the future may offer children with food allergy and their families a viable option to reduce risk or severity of anaphylaxis with phase III trials ongoing for two of these treatment modalities. Food allergy prevalence in children is estimated to be up to 8%. These children are at risk of significant allergic reactions and anaphylaxis. Food avoidance and use of antihistamines or epinephrine has been the standard of care for these patients. This approach also has a significant socioeconomic effects on patients and their families. Recent advancements in understanding food allergy have allowed for exploring new methods of treatment. There is an increasing interest in oral immunotherapy, epicutaneous immunotherapy, or sublingual immunotherapy for food allergy. There have been also innovative approaches to immunotherapy by modification of food allergens (to make them less allergenic while maintain their immunogenicity) or adding adjunctive treatments (probiotics, anti-IgE, etc.) to increase efficacy or safety.

show abstract

Epicutaneous Immunotherapy (EPIT) Is Effective and Safe to Treat Peanut Allergy: A Multi-National Double-Blind Placebo-Controlled Randomized Phase IIb Trial

Cited by 28 publications

References 0 publications

Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: Preclinical proof of concept

Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: Preclinical proof of concept

Desensitization for Peanut Allergies in Children

Emerging Approaches to Food Desensitization in Children

Contact Info

Product

Resources

About