Montelukast treatment may alter the early efficacy of immunotherapy in children with asthma Paweł Majak, MD, PhD, Błażej Rychlik, PhD, Łukasz Pułaski,

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Montelukast treatment may alter the early efficacy of immunotherapy in children with asthma Paweł Majak, MD, PhD, Błażej Rychlik, PhD, Łukasz Pułaski, PhD, Andrzej Błauż, PhD, Brzozowska Agnieszka, MD, PhD, Monika Bobrowska-Korzeniowska, MD, PhD, Piotr Kuna, MD, PhD, Iwona Stelmach, MD, PhD Journal of Allergy and Clinical Immunology Volume 125, Issue 6, Pages 1220-1227 (June 2010) DOI: 10.1016/j.jaci.2010.02.034 Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Flow chart of the study. Two (5.5%) patients were excluded from the ITT population because they withdrew before the second month of intervention (discontinuation of SIT) and therefore had no efficacy assessment. Five patients (13.8%) were excluded from the PP population because of worsening asthma symptoms that required an increase in ICS dose and changes in the SIT schedule. Journal of Allergy and Clinical Immunology 2010 125, 1220-1227DOI: (10.1016/j.jaci.2010.02.034) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Between-group comparisons of reduction of minimal daily dose of inhaled corticosteroid necessary to control the symptoms of asthma (% change; A), asthma symptoms score (points; B), and the resting FEV1 (% of predictive value; C). For between-group comparisons, Mann-Whitney tests were used. Reduction in ICS dose was calculated according to following rule: (ICS dose after the first year of SIT – ICS dose at baseline)/ICS dose at baseline × 100%. m-s, Months; pred., predictive value. Journal of Allergy and Clinical Immunology 2010 125, 1220-1227DOI: (10.1016/j.jaci.2010.02.034) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Between-group comparisons of changes from baseline in the relative expression of Foxp3 (A), in the %CD4+CD25+Foxp3+ cell (B), and in a supernatant concentration of IL-10 (C), TGF-β1 (D), and IL-13 (E). Comparisons were done after 3 and after 12 months (m-s) of SIT in the PP population (left) and in the ITT population (right). Open triangles indicate dropouts from the PP population. The relative expression of Foxp3 indicates the number of Foxp3 cDNA molecules normalized to the number of HPRT1 cDNA molecules. %CD4+CD25+Foxp3+ indicates the percentage of Foxp3+ cells in the population of CD4+CD25+. Journal of Allergy and Clinical Immunology 2010 125, 1220-1227DOI: (10.1016/j.jaci.2010.02.034) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions