Tezepelumab experience in patients with severe uncontrolled asthma: Focus on early response (3 and 6 months of therapy)

Introduction. Tezepelumab is the first biologic targeting TSLP approved for uncontrolled severe asthma (SA) regardless of phenotype/endotype. Data on its effectiveness in real-world clinical practice In Russia are limited.

Aim. To evaluate the clinical effectiveness and safety of tezepelumab in patients with SA over 3 and 6 months of therapy.

Materials and methods. A prospective, multicenter study included 21 patients with SA (16 with T2-endotype, 5 with non-T2endotype). Effectiveness was assessed at baseline, 3, and 6 months based on dynamics in asthma control (ACT questionnaire), exacerbation rate, systemic glucocorticosteroids (SGCS), short-acting bronchodilators (SABD) use, lung function (FEV ), blood eosinophil count, and nasal symptoms (SNOT-22).

Results. At 3 months, significant improvement in asthma control was achieved: the ACT score increased from 15.00 [10.00–18.00] to 22.00 [20.00–24.00] (p < 0.001). The proportion of patients with uncontrolled asthma decreased from 94.4% to 22.2%. SABD use decreased from 28.00 to 14.00 doses/week (p < 0.001), and regular SGCS use was discontinued in all patients. Response heterogeneity was observed: the T2-subgroup showed a significant reduction in annualized exacerbation rate from 4.33 ± 2.67 to 2.00 ± 2.70 (p = 0.032), whereas a trend towards increase was noted in the non-T2-subgroup. Nasal symptoms (SNOT-22) significantly decreased from 35.00 to 28.50 points (p = 0.007). In 5 patients followed for 6 months, the positive dynamics persisted. No adverse events were reported.

Conclusions. Tezepelumab demonstrated high effectiveness and safety in real-world clinical practice in patients with SA, particularly those with a T2-endotype. The findings underscore the need for further data accumulation on tezepelumab use in real-world practice across different patient groups.

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