D1.91 - Baseline characteristics and main clinical outcomes of patients receiving tezepelumab in the framework of use in Special Situations prior to commercialization in Spain (T-ROSS Study)

Severe asthma (SA) represents between 5% to 10% of the asthmatic population in Spain. Despite available treatments, including biologics, 2 out of 3 SA patients remain uncontrolled. These patients have a high risk of exacerbations, hospitalizations, and increased healthcare resource utilization. Tezepelumab, a biologic with a novel mechanism of action, has demonstrated clinical benefits in clinical trials in SA patients.

T-ROSS is an observational, retrospective study in patients 12 years and older with SA meeting criteria to receive tezepelumab under the framework of use in Special Situations prior to commercialization in Spain (Foreign Medication Supply program, FMS). This Program allowed patients with severe uncontrolled asthma who were not eligible to receive any of the approved biologics in Spain or with insufficient response or intolerance to existing biologics to receive tezepelumab.

A total of 33 patients participated in the FMS program, 84.85% being women. The mean (SD) age was 51.85 (13.32) years. There was a mean (SD) of 3.19 (2.98) exacerbations in the 12 months prior to tezepelumab initiation, more than the half (52.48%) were severe. During that period, the mean (SD) of predicted pre-BD FEV₁ was 66 (21.7), the ACT score mean (SD) was of 10.4 (3.4) points and most (60.61%) patients were receiving other biologics (Table 1). In the 12-month follow-up period after tezepelumab initiation, there was a mean (SD) of 1.44 (1.93) exacerbations, which means a reduction of 54.85% of exacerbations. During follow-up, only 30.36% were severe exacerbations, the mean (SD) of predicted pre-BD FEV₁ was 68.87 (19.53) and ACT score mean (SD) was 15.71 (5.89).

In severe uncontrolled asthma patients who participated in the FMS program (patients that were not eligible to receive any of the approved biologics in Spain or with insufficient response or intolerance to these commercialized biologics), patients treated with tezepelumab reduced exacerbations while increased pulmonary function and asthma control, these findings indicate that clinically meaningful benefits of tezepelumab shown in randomized clinical studies translate into real-life practice.