Efficacy of 2 months of allergen-specific immunotherapy with Bet v 1–derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis:

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Efficacy of 2 months of allergen-specific immunotherapy with Bet v 1–derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis: Results of a phase IIb study François Spertini, MD, Gilles DellaCorte, MD, Alexander Kettner, PhD, Frédéric de Blay, MD, PhD, Lars Jacobsen, PhD, Marek Jutel, MD, Margitta Worm, MD, Vincent Charlon, PhD, Christophe Reymond, PhD Journal of Allergy and Clinical Immunology Volume 138, Issue 1, Pages 162-168 (July 2016) DOI: 10.1016/j.jaci.2016.02.044 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Trial profile. Flow diagram illustrating the numbers of subjects screened, randomized, treated, and evaluated during the study. Journal of Allergy and Clinical Immunology 2016 138, 162-168DOI: (10.1016/j.jaci.2016.02.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 RSMSs and pollen exposure during the birch pollen season. The start of the birch pollen season (D0) was set as the first of 3 consecutive days with at least 10 pollen grains/m3. Regional birch pollen air concentration was measured separately in Denmark and Sweden, Latvia/Lithuania, Poland, and France/Switzerland (gray shaded areas). Daily RSMSs (right axis) are reported as smoothed curves in green for placebo, red for 50 μg of Bet v 1 COPs, and blue for 100 μg of Bet v 1 COPs. Journal of Allergy and Clinical Immunology 2016 138, 162-168DOI: (10.1016/j.jaci.2016.02.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Differences from placebo for the Bet v 1 COP–treated groups: A, RSMS; B, MiniRQLQ score; and C, NNSS. LS mean differences of the indicated scores are plotted relative to placebo (green line) for 50 μg of Bet v 1 COPs (red) and 100 μg of Bet v 1 COPs (blue). Ninety-five percent confidence limits are indicated as horizontal colored lines. Analyses were performed during the 2013 birch pollen season on the mITT set. P values were determined by using ANCOVA, with treatment and geographic region as independent factors in the model. Journal of Allergy and Clinical Immunology 2016 138, 162-168DOI: (10.1016/j.jaci.2016.02.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Effect of treatment on levels of Bet v 1–specific IgG4 and IgE. A, Bet v 1–specific IgG4 levels were measured by using ELISA in sera from Bet v 1 COP– and placebo-treated patients of the mITT set before treatment (V0 and V1), 30 days after treatment (V11), at the peak season (V13), and about 14 days after the season (V14). B, Fold increase over baseline in Bet v 1–specific IgG4 levels was calculated for each patient at the indicated visits. Medians (solid line) are displayed within solid boxes showing 25th to 75th percentiles. Whiskers expand to the 10th and 90th percentile, and individual outliers are shown as colored dots. C, Fold increase over baseline in Bet v 1–specific IgE levels was calculated for each patient at the indicated visits and is displayed as indicated in Fig 4, A and B. NS, Not significant (P > .05). *.05 > P > .001, **.001 > P > .0001, and ***.0001 > P, as determined by using the Wilcoxon signed rank test. Journal of Allergy and Clinical Immunology 2016 138, 162-168DOI: (10.1016/j.jaci.2016.02.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Safety analysis, local and systemic AEs, and FEV1 decreases. A, Frequency of treatment-emergent local AEs at the administration site stratified by clinical description and recorded on the safety set (any patient receiving ≥1 injection). B, All systemic AEs with a frequency of 5% or greater stratified by clinical description and recorded on the safety set. C, Frequency of self-tested FEV1 decreases (ΔFEV1) of more than 30% stratified by injections 1 to 5. Journal of Allergy and Clinical Immunology 2016 138, 162-168DOI: (10.1016/j.jaci.2016.02.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions