D2.110 - Real-world evaluation of tezepelumab in patients with severe asthma and chronic rhinosinusitis in France: preliminary results from the ROSE retrospective study

In the phase 3 NAVIGATOR (NCT03347279) study, tezepelumab, an anti-TSLP antibody, improved exacerbation rates, lung function, asthma control and health-related quality of life compared with placebo in patients with uncontrolled SA including those with chronic rhinosinusitis (CRS) with nasal polyps [1,2].

ROSE study aims to describe this population and evaluate in real life the clinical outcomes after initiation of tezepelumab in 2 groups of SA patients: with (CRSwNP) and without (CRSsNP) nasal polyps.

This is a French multicentric retrospective observational real-world study including patients who initiated tezepelumab for SA with comorbid CRS with or without polyps. Data were collected at M0 (including M-12), M6 and M12 from routine medical records.

At M0, 42 patients were analyzed, 21 per group: median age 52.2 years (IQR: 43.9-61.6), 64.3% were female. Comorbidities were frequent (85.7%), notably anxiety (45.7%) and depression (44.4%). Among other comorbidities (n=26), most frequent allergies were to HDM (15,4%), seasonal allergens (11,5%) and pets (7,7%).

A large majority (80.5%) of patients had ≥1 exacerbation during the 12 previous months, and the median ACT score was 13. Median time since CRS diagnosis was 8 years; most common symptoms were rhinorrhea (87.5%) and anosmia (70.8%). Median SNOT-22 score was 56 (IQR: 38–86) (CRSwNP: 64; CRSsNP: 52). Eosinophils >150 cells/mm³, and FeNO >25 ppb were present for 54% and 79% of patients respectively. Among CRSwNP patients, 83.3% had ≥1 sinus surgery.

Most patients had received multiple prior biologic therapies (65.8%) and only 9.8% were bionaïve; 74.4% had received systemic corticosteroids in the previous year, including 31% (n=9) on long-term treatment.

At M6 (n=35), the median ACT score increased from 13 to 17 and the proportion of inadequately controlled patients (ACT≤15) declined from 69.2% to 40.2%. The proportion of patients without exacerbation was 60.6%. In the CRSwNP group, the median SNOT-22 score decreased by 21 points (IQR: -30-5); over 50% of patients achieved a clinically meaningful improvement (≥ 8.9 points).

In a real-world French setting, preliminary data from the first ROSE study patients show that those initiating tezepelumab are rarely biologic naive and often have significant CRS symptoms with impaired quality of life. By M6, asthma control had improved and CRS symptoms were reduced in SA patients with nasal polyps.

[1] NEJM 2021; 384(19):1800-1809 ; [2] J Asthma Allergy. 2023; 16:915-932