Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain

T-ROSS-II has been designed to conduct a new observational study to generate additional evidence on the use of tezepelumab in severe asthma patients in routine clinical practice in Spain after its launch.

This is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma.

Approximately 400 patients meeting the study eligibility criteria will be included in the T-ROSS-II.

Inclusion Criteria:

Patients who received at least 1 tezepelumab dose after commercialization in Spain diagnosed with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and a long-acting β2-agonist ± additional medications for asthma control.

• Patients aged ≥12 years at the index date.
• Patients with continuous enrolment in the data source for at least 12-months before the index date.
• Patients with at least three months of continuous enrolment in the data source after the index date.

Exclusion Criteria:

Patients who received tezepelumab or any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date*.

• Patients who had initiated 3 or more non-tezepelumab biologic treatment (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) for severe asthma at any time prior to the index date).

Study population will consist of all the patients ≥ 12 years old who have received tezepelumab according to the usual clinical practice under the discretion of the physician according with the European SmPc and the reimbursement conditions in Spain between October 1st 2023 and 12 months before the site initiation, who meet all the inclusion criteria and none of the exclusion criteria

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.