Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy Julie Wang, MD, Stacie M. Jones,

Slides:

Advertisements

Similar presentations

Epigenetic modifications and improved regulatory T-cell function in subjects undergoing dual sublingual immunotherapy Ravi S. Swamy, MD, Neha Reshamwala,

Advertisements

Repeated low-dose intradermal allergen injection suppresses allergen-induced cutaneous late responses Giuseppina Rotiroti, MD, Mohamed Shamji, PhD, Stephen.

A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen- induced nasal congestion William T. Barchuk, MD, Anne Marie Salapatek,

Cor a 1–reactive T cells and IgE are predominantly cross-reactive to Bet v 1 in patients with birch pollen–associated food allergy to hazelnut Claudia.

Immunotherapy for Food Allergy: Are We There Yet?

Corinne A. Keet, MD, MS, Pamela A

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy Satya D. Narisety,

Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo- controlled multicenter trial David M. Fleischer, MD, A. Wesley Burks,

Correlation of allergen-specific T follicular helper cell counts with specific IgE levels and efficacy of allergen immunotherapy Yin Yao, MD, Cai-Ling.

Stacie M. Jones, MD, Scott H. Sicherer, MD, A

Epigenetic regulation of established human type 1 versus type 2 cytokine responses Ruey-Chyi Su, PhD, Allan B. Becker, MD, Anita L. Kozyrskyj, PhD, Kent.

Impaired TH17 responses in patients with chronic mucocutaneous candidiasis with and without autoimmune polyendocrinopathy–candidiasis–ectodermal dystrophy

Maternal allergy increases susceptibility to offspring allergy in association with TH2- biased epigenetic alterations in a mouse model of peanut allergy

Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical.

Cor a 1–reactive T cells and IgE are predominantly cross-reactive to Bet v 1 in patients with birch pollen–associated food allergy to hazelnut Claudia.

Toll-like receptor 7–induced naive human B-cell differentiation and immunoglobulin production Mark C. Glaum, MD, PhD, Shilpi Narula, MD, Decheng Song,

Treatment of chronic rhinosinusitis with intranasal amphotericin B: A randomized, placebo-controlled, double-blind pilot trial Jens U. Ponikau, MD, David.

Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy Julie Wang, MD, Stacie M. Jones,

Targeting Toll-like receptors on dendritic cells modifies the TH2 response to peanut allergens in vitro Pierre Pochard, PhD, Brian Vickery, MD, M. Cecilia.

Julie Wang, MD, James H. Godbold, PhD, Hugh A. Sampson, MD

Effective treatment of house dust mite–induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled.

A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy Robert A.

Bruce M. Prenner, MD, Bobby Q. Lanier, MD, David I

Glucocorticoids promote intrinsic human TH17 differentiation

Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy Albrecht Bufe, PhD, MD, Peter Eberle, MD, Eivy.

Investigation of peanut oral immunotherapy with CpG/peanut nanoparticles in a murine model of peanut allergy Kamal D. Srivastava, PhD, Alyssa Siefert,

Tolerance-like mediated suppression by mesenchymal stem cells in patients with dust mite allergy–induced asthma Simi Kapoor, MD, Shyam A. Patel, PhD,

Response to sublingual immunotherapy with grass pollen extract: Monotherapy versus combination in a multiallergen extract Sheila M. Amar, MD, Ronald.

A randomized controlled study of peanut oral immunotherapy: Clinical desensitization and modulation of the allergic response Pooja Varshney, MD, Stacie.

A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy Justin M. Skripak, MD, Scott D. Nash, MD, Hannah.

Kathleen R. Bartemes, BA, Gail M. Kephart, BS, Stephanie J

Food allergy herbal formula 2 protection against peanut anaphylactic reaction is via inhibition of mast cells and basophils Ying Song, MD, Chunfeng Qu,

Katherine G. MacDonald, BSc, Nicholas A. J

Food Allergy Herbal Formula-2 silences peanut-induced anaphylaxis for a prolonged posttreatment period via IFN-γ–producing CD8+ T cells Kamal D. Srivastava,

Administration of a probiotic with peanut oral immunotherapy: A randomized trial Mimi L.K. Tang, PhD, Anne-Louise Ponsonby, PhD, Francesca Orsini, MSc,

Cigarette smoke combined with Toll-like receptor 3 signaling triggers exaggerated epithelial regulated upon activation, normal T-cell expressed and secreted/CCL5.

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy Satya D. Narisety,

A. Wesley Burks, MD, Robert A. Wood, MD, Stacie M. Jones, MD, Scott H

Short-term subcutaneous grass pollen immunotherapy under the umbrella of anti–IL-4: A randomized controlled trial Adam M. Chaker, MD, Mohamed H. Shamji,

Anna Nowak-Wegrzyn, MD, Katherine A. Bloom, MD, Scott. H

A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen- induced nasal congestion William T. Barchuk, MD, Anne Marie Salapatek,

Food allergy: A review and update on epidemiology, pathogenesis, diagnosis, prevention, and management Scott H. Sicherer, MD, Hugh A. Sampson, MD Journal.

Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial Hendrik.

Staphylococcal exotoxins are strong inducers of IL-22: A potential role in atopic dermatitis Margarete Niebuhr, MD, Helena Scharonow, MS, Merle Gathmann,

Jennifer S. Kim, MD, Anna Nowak-Węgrzyn, MD, Scott H

What is an “eosinophilic phenotype” of asthma?

Corinne A. Keet, MD, MS, Pamela A

Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment

The Chinese herbal medicine formula FAHF-2 completely blocks anaphylactic reactions in a murine model of peanut allergy Kamal D. Srivastava, MPhil, Jacob.

Matthew J. Loza, PhD, Susan Foster, PhD, Stephen P

Sara Paveglio, PhD, MS, Erin Bennett, MS, Kelly L. Hawley, PhD, Adam P

Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis Karl-Christian Bergmann, MD, Pascal Demoly,

Efficacy and tolerability of antiasthma herbal medicine intervention in adult patients with moderate-severe allergic asthma Ming-Chun Wen, MD, Chun-Hua.

Xiu-Min Li, MD, LaVerne Brown, PhD

Reply Journal of Allergy and Clinical Immunology

CCL17/thymus and activation-regulated chemokine induces calcitonin gene–related peptide in human airway epithelial cells through CCR4 Kandace Bonner,

Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber

Grass pollen immunotherapy: IL-10 induction and suppression of late responses precedes IgG4 inhibitory antibody activity James N. Francis, PhD, Louisa.

Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study

Short course of systemic corticosteroids in sinonasal polyposis: A double-blind, randomized, placebo-controlled trial with evaluation of outcome measures

Dietary baked egg accelerates resolution of egg allergy in children

Early improvement in basophil sensitivity predicts symptom relief with grass pollen immunotherapy Johannes Martin Schmid, MD, Peter Adler Würtzen, PhD,

Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy Stacie M. Jones, MD, A.

Consumer attitudes and risks associated with packaged foods having advisory labeling regarding the presence of peanuts Susan L. Hefle, PhD, Terence J.

Statistical issues in clinical trials that involve the double-blind, placebo-controlled food challenge Vernon M. Chinchilli, PhD, Laura Fisher, MD, Timothy.

Repeated low-dose intradermal allergen injection suppresses allergen-induced cutaneous late responses Giuseppina Rotiroti, MD, Mohamed Shamji, PhD, Stephen.

Probiotic supplementation for the first 6 months of life fails to reduce the risk of atopic dermatitis and increases the risk of allergen sensitization.

Sublingual immunotherapy for peanut allergy: Clinical and immunologic evidence of desensitization Edwin H. Kim, MD, J. Andrew Bird, MD, Michael Kulis,

Safety and efficacy of repeated monthly carboplatin desensitization

CCL17/thymus and activation-regulated chemokine induces calcitonin gene–related peptide in human airway epithelial cells through CCR4 Kandace Bonner,

Presentation transcript:

Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy Julie Wang, MD, Stacie M. Jones, MD, Jacqueline A. Pongracic, MD, Ying Song, MD, Nan Yang, PhD, Scott H. Sicherer, MD, Melanie M. Makhija, MD, Rachel G. Robison, MD, Erin Moshier, MS, James Godbold, PhD, Hugh A. Sampson, MD, Xiu-Min Li, MD Journal of Allergy and Clinical Immunology Volume 136, Issue 4, Pages 962-970.e1 (October 2015) DOI: 10.1016/j.jaci.2015.04.029 Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Consort flow chart for this randomized, double-blind, placebo-controlled trial. After screening and baseline DBPCFCs with 2 g of protein, subjects were randomized to receive FAHF-2 or placebo (2:1), 10 tablets 3 times a day, for 6 months. After 6 months of treatment, a DBPCFC with 5 g of protein was performed to assess for the effect of the study medication. Subjects who demonstrated an improvement in tolerance (amount of food allergen that could be consumed without dose-limiting symptoms) as defined for the primary end point returned for a DBPCFC 3 months off therapy to assess for sustained effect. OFC, Oral food challenge. Journal of Allergy and Clinical Immunology 2015 136, 962-970.e1DOI: (10.1016/j.jaci.2015.04.029) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Cumulative tolerated dose at oral food challenge (OFC) at baseline and after the 6-month treatment period comparing the active- and placebo-treated groups. The mean cumulative dose tolerated by the active group at baseline was 266.2 mg (95% CI, 150.3-382.1 mg), and at 6 months, the dose was 369.2 mg (95% CI, 47.0-691.4 mg). The mean cumulative dose tolerated by the placebo group at baseline was 352.5 mg (95% CI, 108.5-596.5 mg), and at 6 months, the dose was 1022.1 mg (95% CI, 326.4-1717.8 mg). Journal of Allergy and Clinical Immunology 2015 136, 962-970.e1DOI: (10.1016/j.jaci.2015.04.029) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 FAHF-2 suppressed IL-5 and increased IL-10 levels in vitro. A, PBMCs (4 × 105) from subjects (n = 12) were obtained at the baseline visit and cultured in AIM-V media alone, with relevant allergen (200 μg/mL) or allergen plus FAHF-2 (125 or 250 μg/mL). After a 3-day culture, culture supernatants were harvested, and IL-5, IFN-γ, and IL-10 levels were measured by means of ELISA. Cell viability was determined by using trypan blue dye exclusion. B, IL-5, IL-10, and IFN-γ production from PBMCs obtained at baseline with or without FAHF-2 in vitro culture (n = 53). Cultures were conducted as described in Fig 3, A. Data are shown as means ± SEMs and analyzed by using a left-censored, log-normal, repeated-measures tobit model. *P < .05, allergen versus allergen plus FAHF-2; ∗∗P < .01; and ∗∗∗P < .001. Journal of Allergy and Clinical Immunology 2015 136, 962-970.e1DOI: (10.1016/j.jaci.2015.04.029) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 FAHF-2 increased numbers of Treg cells in vitro. PBMCs from subjects obtained at baseline were cultured as described in Fig 2. After a 3-day culture, numbers of CD4+CD25+FoxP3+ Treg cells were determined by means of flow cytometry. Data were analyzed by using FlowJo software. A, Dot plots are representative of an individual subject. B, Bar graph showing data for 10 subjects. Data are shown as means ± SEMs and analyzed by using a mixed model with a random intercept on natural log-transformed Treg cell percentages in Fig 3, B. *P < .05, allergen versus allergen plus FAHF-2. Journal of Allergy and Clinical Immunology 2015 136, 962-970.e1DOI: (10.1016/j.jaci.2015.04.029) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions