Tezepelumab in Real life setting: elucidating the clinical effectiveness, tolerability, and safety in severe asthma patients

Tezepelumab is a thymic stromal lymphopoietin antibody approved for severe asthma without biomarker limitations. However, there is insufficient real-world evidence to corroborate the findings of randomized clinical trials. This is a retrospective two-center study of patients with uncontrolled severe asthma. We collected baseline data from up to 12 months prior to and up to 6 months on tezepelumab therapy. We compared the data for Asthma Control Test (ACT), Asthma Control Questionnaire-6 (ACQ-6), sino-nasal outcome test (SNOT-22), biomarkers, and lung function using t-test and Wilcoxon test. The data included 27 patients who received tezepelumab every 4 weeks for 5 months, 16 of whom also had a 6-month follow-up. Mean age was 60,75±11,8 years, with a median number of exacerbations in the last 12 months at 2,56 (0-15). The FEV1 was 55±19%, the blood eosinophil count (BEC) 299,58±372,72 /µl, and the FeNO 42,63±43,1 ppb. ACQ-6 scored 3,41±3,77 while ACT averaged at 13,62±4,7. The SNOT-22 score was 31,65±23,7. Never-smokers comprised 28,6% of the patients, while 25% had nasal polyps and 78,6% had allergies. Significant improvements were observed in ACT after 5 and 6 months (both p<0.001), ACQ-6 (p<0.01 at month 5 and p=0.004 at month 6) and SNOT-22 (p=0.05 at month 5 and p=0.029 at month 6). FEV1 significantly increased at month 5 (p<0.001). There were no significant improvements in FeNO and BEC after 6 months of treatment (p > 0.05). No safety concerns were observed. Over the 6-months period, tezepelumab showed improvement in asthma control and FEV1 in patients with uncontrolled asthma.