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SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial  Stephen.

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Presentation on theme: "SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial  Stephen."— Presentation transcript:

1 SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial  Stephen R. Durham, MD, Waltraud Emminger, MD, Alexander Kapp, MD, PhD, Jan G.R. de Monchy, MD, Sabina Rak, MD, Glenis K. Scadding, MD, FRCP, Peter A. Wurtzen, PhD, Jens S. Andersen, PhD, Bente Tholstrup, MSc, Bente Riis, PhD, Ronald Dahl, MD  Journal of Allergy and Clinical Immunology  Volume 129, Issue 3, Pages e5 (March 2012) DOI: /j.jaci Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

2 Fig 1 Weighted rhinoconjunctivitis combined symptom and medication score for the 5 grass pollen seasons of the trial and averaged over all seasons with relative differences between groups and 95% CI. All relative differences were statistically significant. Adj., Adjusted; avg., averaged. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

3 Fig 2 Weighted RCS for grass AIT and placebo as a function of grass pollen counts (left y-axis). The gray curve is the cumulated pollen curve (right y-axis). The plot is based on 80,958 diary data over the 5 years of the trial. The vertical bars are 95% prediction intervals. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

4 Fig 3 A, Average grass pollen exposures, for participants with diary data on the given day, during the 5 grass pollen seasons of the trial ( ). B, Linear regression of the relative difference in the weighted RCS against the cumulative grass pollen counts in the initial 3 weeks of the grass pollen season (S, season; FS, follow-up season). Lowest cumulative counts were observed during the 2nd follow-up season (FS2). Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

5 Fig 4 The relation between weekly overall rhinoconjunctivitis quality of life questionnaire (RQLQ) score and number of weekly days with severe symptoms (-∆-, left y-axis) and the odds ratio for having days with severe symptoms in the grass AIT group versus the placebo group (-●-, right y-axis). Data included for all 5 seasons of the trial. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

6 Fig 5 Change from baseline in specific IgE-blocking factor (A), specific IgG4 levels (B), and facilitated allergen presentation (FAP) inhibition (C). Grass pollen seasons are indicated by gray boxes and end of treatment by dotted lines. The differences between grass AIT and placebo groups were significant at all assessments. All samples from years 1 to 5 were analyzed after the end of the trial. IgG4 level measurements for years 1 to 5 are presented by using Phadia CAP RAST (Phadia AB, Uppsala, Sweden). In previous reports, IgG4 analyses were performed by using the Centaur system19 for which reagents became unavailable for the last year of the trial. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

7 Fig 6 Onset of the 4 most common types of adverse events (data from active group only). Note that “1 day” refers to the same day as treatment was started. None of these types of adverse events occurred during the 5th year of the trial. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

8 Fig E1 Overview of trial participants during the 5th year of the trial. ∗There were no statistically significant difference in treatment effect during the grass pollen season 2005 between participants continuing and participants not continuing in the extension. †Other reasons for withdrawal included “lost to follow-up,” “pregnancy,” “withdrawal of consent,” “subject noncompliance,” or “other.” Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

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