D1.111 - Tezepelumab reduces in patients with severe allergic asthma and rhinoconjunctivitis not only bronchial but also nasal and conjunctival symptoms – results from an exposure chamber study

Purpose of study: Tezepelumab is licensed and effective in all phenotypes of severe asthma but has not been investigated on its effect on IgE mediated lower and upper airways symptoms. The study aimed atinvestigating the anti-allergic effects of tezepelumab in subjects with severe allergic asthma with associated nasal and conjunctival symptoms during allergen challenge with grass pollen, house dust mite or cat allergen in an Allergen Exposure Chamber (AEC).

Method: Measurement of Total Symptom Score (TSS) including Total Eye (TESS: Itching, foreign body sensation, tearing, redness),Total Nasal Symptom Score (TNSS: itching, sneezing, runny nose, stuffy nose), and Total Bronchial Symptom Score (TBSS: cough, wheezing, shortness of breath) four  months after first injection of Tezepelumab during 2nd provocation (V4) in comparison to the 1st provocation (V1) in an exposure chamber. Included were 21 adults with Severe Allergic Asthma due to grass pollen (n=10). mite (n=6), or cat (n=5).                                              Lung function (FEV1, PEF, FeNO), Peak Nasal Inspiratory Flow (PNIF), and amount of nasal secretion during and after exposure were secondary parameters. All patients agreed to publish their data.

Results: The primary objective TSS at V4 was reduced by 50% in comparison to V1 (Median from 8 to 4, Hodges-Lehmann effect -7.5, p-value 0.0003, see figure). The TBSS was reduced (Median from 3.0  to 0 at V4). Nasal secretion was reduced at V4 on 100%, (p-value 0.0654). PNIF was 18.2% higher at V4 vs. V1 (p=0.0053). FEV1, PEF, and FeNO showed no significant changes. 

Conclusion: Tezepelumab has a remarkable anti-allergic effect on severe allergic asthma and allergic rhinoconjunctivitis due to gras pollen, cat dander and house dust mites; after omalizumab, it is the second anti-allergic biologic.