The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma Kai-Michael Beeh, MD, Frank Kanniess, MD, Frank Wagner, MD, Cordula.

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Presentation transcript:

The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma Kai-Michael Beeh, MD, Frank Kanniess, MD, Frank Wagner, MD, Cordula Schilder, MD, Ingomar Naudts, MD, Anya Hammann-Haenni, PhD, Joerg Willers, PhD, Hans Stocker, PhD, Philipp Mueller, MD, Martin F. Bachmann, PhD, Wolfgang A. Renner, PhD Journal of Allergy and Clinical Immunology Volume 131, Issue 3, Pages 866-874 (March 2013) DOI: 10.1016/j.jaci.2012.12.1561 Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Outline of trial design and interventions performed. Prior to randomization, patients were converted to a run-in daily dosage of either 400 μg (for patients on 500-800 μg BDP equivalent) or 800 μg of BDP (for patients on >800 μg BDP equivalent) inhaled morning and evening. The first 3 subcutaneous injections of study drug were given weekly and then every second week on opposite upper arms, alternatively. During the first 4 weeks, patients were maintained on 100% BDP. Then, the dose was reduced to 50% for the following 4 weeks. At the end of week 8, BDP was completely withdrawn for the last 4 weeks, if clinically justifiable and following predefined safety criteria (see this article's Online Repository at www.jacionline.org). Site visits took place every 1 or 2 weeks. *Airway hyperresponsiveness was assessed at the time of maximum BDP reduction or at week 12. Journal of Allergy and Clinical Immunology 2013 131, 866-874DOI: (10.1016/j.jaci.2012.12.1561) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 CONSORT diagram. ITT, Intention to treat. Journal of Allergy and Clinical Immunology 2013 131, 866-874DOI: (10.1016/j.jaci.2012.12.1561) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Change in ASMS and ACQ score and in FEV1 from baseline. A, Changes in ASMS given as delta scores between baseline and the respective visits. Absolute ASMS baseline and week 12 scores: Placebo 0.91 and 1.52; QbG10 1.22 and 1.01, respectively. B, Changes in reported scores on the 7-item-ACQ. Absolute baseline and week 12 scores: Placebo 0.92 and 1.48; QbG10 0.85 and 0.77, respectively. C, Changes in FEV1 of the 2 groups. Patients' morning FEV1 was measured always at the same time (±1 hour), and the best (highest) FEV1 per time point was documented. Absolute FEV1 baseline and week 12 scores: Placebo 2992 and 2741 mL; QbG10 3044 and 3025 mL, respectively. P values (repeated measures) were calculated by using SAS Proc mixed. Error bars represent 95% confidence intervals. *P < .05 calculated for the mean difference between placebo and QbG10 at the respective week after randomization. Journal of Allergy and Clinical Immunology 2013 131, 866-874DOI: (10.1016/j.jaci.2012.12.1561) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Change in average (asthma) symptom score (ASS) and average (asthma) medication score (AMS) from baseline. Changes in ASS (A) and AMS (B) determined with the patients' daily recordings in the asthma diaries are presented as delta scores between baseline and the respective visits. Both scores were calculated as the average between 2 visits. P values (repeated measures) were calculated by using SAS Proc mixed. Error bars represent 95% confidence intervals. *P < .05 calculated for the mean difference between placebo and QbG10 at the respective week after randomization. Absolute ASS baseline and week 12 scores: Placebo 0.91 and 1.18; QbG10 1.11 and 0.74, respectively. Absolute AMS baseline and week 12 scores: Placebo 0.91 and 1.86; QbG10 1.34 and 1.29, respectively. Journal of Allergy and Clinical Immunology 2013 131, 866-874DOI: (10.1016/j.jaci.2012.12.1561) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Percentage of patients with well-controlled asthma. The bars represent the percentage of patients with a 7-item-ACQ score of ≤0.75 points. P value (repeated measures) was calculated by using the Proc Genmod procedure. *P < .05 calculated for the mean difference between placebo and QbG10 at the respective week after randomization. Journal of Allergy and Clinical Immunology 2013 131, 866-874DOI: (10.1016/j.jaci.2012.12.1561) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions