Pneumologie 2021; 75(S 01): S33
DOI: 10.1055/s-0041-1723320
Latebreaking Abstracts 2021

Efficacy of CSJ117 on allergen-induced asthmatic response in mild atopic asthma patients

J Hohlfeld
1   Fraunhofer Item, Klinische Atemwegsforschung; Fraunhofer Institute for Toxicology and Experimental Medicine and Hannover Medical School, Hannover, Germany; Member of the German Center for Lung Research
,
G M Gauvreau
2   Department of Medicine, Mcmaster University, Hamilton, Ontario, Canada
,
L P Boulet
3   Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Laval, Qc, Canada
,
D W Cockcroft
4   Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan, Saskatoon, Sk, Canada
,
B E Davis
4   Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan, Saskatoon, Sk, Canada
,
J M FitzGerald
5   Institute for Heart and Lung Health, University of British Columbia, Vancouver, Bc, Canada
,
S Korn
6   University Mainz, Mainz, Germany
,
O Kornmann
7   Institute for Clinical Research, Frankfurt, Germany
,
R Leigh
8   Faculty of Medicine, Calgary, Ab, Canada
,
I Mayers
9   Division of Pulmonary Medicine, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Ab, Canada
,
H Watz
10   Pulmonary Research Institute, at Lungenclinic Groshansdorf, Airway Research Center North (Arcn), German Center for Lung Research (DZL), Großhansdorf, Germany
,
S Grant
11   Novartis Institute of Biomedical Research, Cambridge, MA, USA
,
M Jain
12   Novartis Institute of Biomedical Research, Cambridge, MA, Usa;
,
M Cabanski
12   Novartis Institute of Biomedical Research, Cambridge, MA, Usa;
,
P Pertel
12   Novartis Institute of Biomedical Research, Cambridge, MA, Usa;
,
J Lecot
13   Medstat Ltd, Suffolk, UK
,
P OʼByrne
2   Department of Medicine, Mcmaster University, Hamilton, Ontario, Canada
› Author Affiliations
› Further Information
Also available ateRef
 

Introduction: CSJ117 is a potent neutralizing antibody fragment against human Thymic stromal lymphopoietin (TSLP).

Methods: In this double-blind, placebo-controlled study, 28 mild, atopic asthmatics were randomized to receive 4 mg CSJ117 (n = 15) or placebo (n = 13) for 12 weeks. Allergen inhalation challenge (AIC) was conducted at screening, day 42 and day 84. The primary efficacy variable was the late asthmatic response (LAR), measured 3 to 7 hours after AIC at day 84. Other outcomes included the early asthmatic response (EAR) measured within 2 hours after AIC, fractional exhaled nitric oxide (FeNO) level, and sputum eosinophils. Data were analyzed using one-sided repeated measures ANOVA (β = 10%) with baseline as covariate.

Results: CSJ117 attenuated the allergen-induced LAR and EAR at day 84. The time-adjusted AUC percentage decrease and the maximum decrease in FEV1 from pre-AIC were significantly lower in the CSJ117 group, compared to placebo (4.20% vs. 11.38%, p = 0.008, and 9.28% vs. 17.70%, P = 0.029, during LAR; 12.83% vs. 17.09%, P = 0.097, and 25.48% vs. 30.90%, P = 0.105, during EAR). CSJ117 significantly attenuated the allergen-induced increase in % sputum eosinophils after AIC on day 84. CSJ117 significantly reduced FeNO before AIC at Day 83, but did not affect the allergen-induced change.

Conclusion: CSJ117 reduced both allergen-induced bronchoconstriction and sputum eosinophilia, as well as FeNO levels pre AIC. These findings demonstrate CSJ117’s ability to attenuate airway inflammation in allergic asthmatics and support further studies as an inhaled anti-TSLP.



Publication History

Article published online:
30 April 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany