Presentation is loading. Please wait.

Presentation is loading. Please wait.

Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32  Verena Niederberger, MD, Angela Neubauer, PhD,

Published byFranziska Hafner Modified over 5 years ago

Similar presentations

Presentation on theme: "Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32  Verena Niederberger, MD, Angela Neubauer, PhD,"— Presentation transcript:

1 Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32  Verena Niederberger, MD, Angela Neubauer, PhD, Philippe Gevaert, MD, Mihaela Zidarn, MD, Margitta Worm, MD, Werner Aberer, MD, Hans Jørgen Malling, MD, Oliver Pfaar, MD, Ludger Klimek, MD, Wolfgang Pfützner, MD, Johannes Ring, MD, Ulf Darsow, MD, Natalija Novak, MD, Roy Gerth van Wijk, MD, Julia Eckl-Dorna, MD, PhD, Margarete Focke-Tejkl, PhD, Milena Weber, MSc, Hans-Helge Müller, PhD, Joachim Klinger, PhD, Frank Stolz, PhD, Nora Breit, MSc, Rainer Henning, PhD, Rudolf Valenta, MD  Journal of Allergy and Clinical Immunology  Volume 142, Issue 2, Pages e9 (August 2018) DOI: /j.jaci Copyright © 2017 The Authors Terms and Conditions

2 Fig 1 Study design. Patients recruited during the screening year (2012) were randomized at visit 4 (R) and treated 3 times preseasonally during each of the 2 treatment years (2013 and 2014) and once in October 2013 (investigational medicinal product [IMP] administration). Symptoms, medication, VAS, and quality-of-life data were obtained by using eDiaries from mid-April until mid-August (green background). Titrated SPTs were performed at 8 time points, and blood samples were taken at 11 time points (red arrows). Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

3 Fig 2 Study populations, enrollment, and randomization. Numbers of subjects screened and signing informed consent (IC) forms, randomized, receiving the first injection (SA population), entering treatment year 2, and completing the study are shown. FAS1 (red numbers) and FAS2 (green numbers) are displayed. Discontinuations (numbers and reasons) are indicated. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

4 Fig 3 Comparison of SMSs in treatment groups. Shown are mean SMSs with 95% CIs (y-axes) during the peak pollen seasons of treatment years 1 (placebo, BM32 low, and BM32 high groups) and 2 (placebo, BM32 pooled, BM32 low-low, and BM32 high-low groups) for the FAS population (A) and the modified FAS population (B), which excluded subjects with grass pollen–specific IgE levels of less than 3.5 kUA/L when treatment started. P values for differences of LS means between groups are indicated. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

5 Fig 4 Well-being measured by using the VAS and RQLQ in treatment groups. A, Shown are mean VAS scores with 95% CIs (y-axes) during the peak pollen seasons of treatment years 1 (placebo, BM32 low, and BM32 high group) and 2 (placebo, BM32 pooled, BM32 low-low, and BM32 high-low groups) for the FAS. P values for differences in LS means between groups are indicated. B and C, Rhinoconjunctivitis-related quality of life parameters recorded for the indicated groups during the pollen peak seasons during year 1 (Fig 4, B) and year 2 (Fig 4, C) are displayed as mean scores in spider plot diagrams. P values for differences in LS means between groups are listed underneath the spider plots for each of the parameters. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

6 Fig 5 Development of allergen-specific IgG and IgG subclass responses. Shown are mean IgG (A), IgG1 (B), and IgG4 (C) levels (y-axes, OD values) specific for the 4 major grass pollen allergens (Phl p 1, Phl p 2, Phl p 5, and Phl p 6) for the different treatment groups (left to right: BM32 pooled, BM32 low/low-low, BM32 high/high-low, and placebo groups) for 7 time points during the study. Injections and GPSs are indicated. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

7 Fig 5 Development of allergen-specific IgG and IgG subclass responses. Shown are mean IgG (A), IgG1 (B), and IgG4 (C) levels (y-axes, OD values) specific for the 4 major grass pollen allergens (Phl p 1, Phl p 2, Phl p 5, and Phl p 6) for the different treatment groups (left to right: BM32 pooled, BM32 low/low-low, BM32 high/high-low, and placebo groups) for 7 time points during the study. Injections and GPSs are indicated. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

8 Fig 6 Effects of immunotherapy with BM32 on grass pollen allergen–specific IgE levels. A, Mean timothy grass pollen allergen–specific IgE levels (y-axes, kUA/L) for the different treatment groups (left to right: BM32 pooled, BM32 low/low-low, BM32 high/high-low, and placebo groups) for 7 time points during the study. Injections and GPSs are indicated. B, Changes in mean levels of IgE specific for the 4 major grass pollen allergens (y-axes: kUA/L) between visits 8 and 9 (year 1) and visits 15 and 16 (year 2) for the different treatment groups (year 1: placebo, BM32 low, and BM32 high groups; year 2: placebo, BM32 pooled, BM32 low-low, and BM32 high-low groups). P values indicate differences between the placebo and actively treated groups. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

9 Fig E1 Definition of analyzed subpopulations. Venn diagram showing the SA population, as well as the FAS1 and FAS2 populations, for treatment years 1 and 2, respectively (upper part). The table below defines the populations and shows subject numbers. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

10 Fig E2 Comparison of SSs and MSs in treatment groups. A and B, Mean SSs with 95% CIs (y-axes) during the peak pollen seasons of treatment years 1 (placebo, BM32 low, and BM32 high groups) and 2 (placebo, BM32 pooled, BM32 low-low, and BM32 high-low groups) for the FAS (Fig E2, A) and modified FAS (Fig E2, B) populations, which excluded subjects with grass pollen–specific IgE levels of less than 3.5 kUA/L when treatment started. C and D, Mean MSs with 95% CIs for the FAS (Fig E2, C) and modified FAS (Fig E2, D) populations are displayed in the same way. P values for differences of the LS means between groups are indicated. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

11 Fig E3 Association of grass pollen allergen–specific IgE levels at screening and treatment effects in years 2 and 1. A, Comparison of mean SMSs (y-axis, whiskers represent 5% to 95% of the CI) of FAS2 subjects (year 2) from the placebo group (gray symbols) and pooled treatment groups (blue symbols) and of subgroups thereof with different grass pollen allergen–specific IgE levels. B, Correlation between mean reductions in SMS (placebo vs treatment groups) and grass pollen allergen–specific IgE baseline levels (year 2). Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

12 Fig E4 Changes of well-being as measured by using the VAS in the 2 treatment years compared with baseline values. Comparison of mean levels of well-being (y-axis) during the whole GPS at baseline (2012) with the 2 treatment years (2013 and 2014) in subjects with available baseline data from different groups (placebo, BM32 low/low-low, BM32 high/high-low, and BM32-pooled groups). P values denote differences of LS means between 2012 and the 2 treatment years. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

13 Fig E5 Comparison of asthma scores in treatment groups. Shown are mean asthma scores with 95% CIs (y-axes) during the peak pollen seasons of treatment years 1 (placebo, BM32 low-dose, and BM32 high-dose groups) and 2 (placebo, BM32 pooled, BM32 low-low, and BM32 high-low groups) for the FAS population. P values for comparisons of the placebo group with treatment groups are indicated. Journal of Allergy and Clinical Immunology  , e9DOI: ( /j.jaci ) Copyright © 2017 The Authors Terms and Conditions

Download ppt "Safety and efficacy of immunotherapy with the recombinant B-cell epitope–based grass pollen vaccine BM32  Verena Niederberger, MD, Angela Neubauer, PhD,"

Similar presentations

Intradermal grass pollen immunotherapy increases TH2 and IgE responses and worsens respiratory allergic symptoms  Anna Slovick, MRCS, Abdel Douiri, PhD,

Intradermal grass pollen immunotherapy increases TH2 and IgE responses and worsens respiratory allergic symptoms  Anna Slovick, MRCS, Abdel Douiri, PhD,
Repeated low-dose intradermal allergen injection suppresses allergen-induced cutaneous late responses  Giuseppina Rotiroti, MD, Mohamed Shamji, PhD, Stephen.

Repeated low-dose intradermal allergen injection suppresses allergen-induced cutaneous late responses  Giuseppina Rotiroti, MD, Mohamed Shamji, PhD, Stephen.
Sensitization to cat and dog allergen molecules in childhood and prediction of symptoms of cat and dog allergy in adolescence: A BAMSE/MeDALL study  Anna.

Sensitization to cat and dog allergen molecules in childhood and prediction of symptoms of cat and dog allergy in adolescence: A BAMSE/MeDALL study  Anna.
Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy  Christian Lupinek, Kurt Derfler, Silvia Lee, Thomas Prikoszovich, Oliver Movadat,

Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy  Christian Lupinek, Kurt Derfler, Silvia Lee, Thomas Prikoszovich, Oliver Movadat,
Volume 11, Pages (September 2016)

Volume 11, Pages (September 2016)
Comparison of the immunogenicity of BM32, a recombinant hypoallergenic B cell epitope–based grass pollen allergy vaccine with allergen extract–based vaccines 

Comparison of the immunogenicity of BM32, a recombinant hypoallergenic B cell epitope–based grass pollen allergy vaccine with allergen extract–based vaccines 
Birch pollen–related food allergy: Clinical aspects and the role of allergen-specific IgE and IgG4 antibodies  Marija Geroldinger-Simic, MD, Thomas Zelniker,

Birch pollen–related food allergy: Clinical aspects and the role of allergen-specific IgE and IgG4 antibodies  Marija Geroldinger-Simic, MD, Thomas Zelniker,
Efficacy and safety of birch pollen immunotherapy for local allergic rhinitis  Andrzej Bożek, MD, PhD, Krzysztof Kołodziejczyk, MD, PhD, Jerzy Jarząb,

Efficacy and safety of birch pollen immunotherapy for local allergic rhinitis  Andrzej Bożek, MD, PhD, Krzysztof Kołodziejczyk, MD, PhD, Jerzy Jarząb,
A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy  Satya D. Narisety,

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy  Satya D. Narisety,
SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial  Stephen.

SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial  Stephen.
Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5– grass pollen tablet for seasonal allergic rhinitis  Alain Didier, MD,

Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5– grass pollen tablet for seasonal allergic rhinitis  Alain Didier, MD,
Prediction of IgE-binding epitopes by means of allergen surface comparison and correlation to cross-reactivity  Fabio Dall'Antonia, PhD, Anna Gieras,

Prediction of IgE-binding epitopes by means of allergen surface comparison and correlation to cross-reactivity  Fabio Dall'Antonia, PhD, Anna Gieras,
Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults  Peter S. Creticos, MD, Jennifer Maloney,

Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults  Peter S. Creticos, MD, Jennifer Maloney,
Epicutaneous allergen-specific immunotherapy ameliorates grass pollen–induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation.

Epicutaneous allergen-specific immunotherapy ameliorates grass pollen–induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation.
Development and characterization of a recombinant, hypoallergenic, peptide-based vaccine for grass pollen allergy  Margarete Focke-Tejkl, PhD, Milena.

Development and characterization of a recombinant, hypoallergenic, peptide-based vaccine for grass pollen allergy  Margarete Focke-Tejkl, PhD, Milena.
Blocking antibodies induced by immunization with a hypoallergenic parvalbumin mutant reduce allergic symptoms in a mouse model of fish allergy  Raphaela.

Blocking antibodies induced by immunization with a hypoallergenic parvalbumin mutant reduce allergic symptoms in a mouse model of fish allergy  Raphaela.
Skin test diagnosis of grass pollen allergy with a recombinant hybrid molecule  Carine Metz-Favre, MD, Birgit Linhart, PhD, Margarete Focke-Tejkl, PhD,

Skin test diagnosis of grass pollen allergy with a recombinant hybrid molecule  Carine Metz-Favre, MD, Birgit Linhart, PhD, Margarete Focke-Tejkl, PhD,
Efficacy of subcutaneous and sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: A meta-analysis–based comparison  Danilo Di.

Efficacy of subcutaneous and sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: A meta-analysis–based comparison  Danilo Di.
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.

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.
Birch pollen immunotherapy results in long-term loss of Bet v 1–specific TH2 responses, transient TR1 activation, and synthesis of IgE-blocking antibodies 

Birch pollen immunotherapy results in long-term loss of Bet v 1–specific TH2 responses, transient TR1 activation, and synthesis of IgE-blocking antibodies 

Similar presentations

Ads by Google