The objectives of this study are to describe the incidence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma or CRSwNP in South Korea.
This is a prospective, single-arm, multicenter, observational study to evaluate the safety and effectiveness of tezepelumab from treatment initiation up to 24 weeks in patients who are prescribed tezepelumab according to its approved indication in South Korea. The effectiveness assessment will estimate the proportion of patients with improved asthma control or a clinically meaningful improvement in SNOT-22 scores, from treatment initiation up to 24 weeks after the initiation of tezepelumab. This study design will reflect the actual management of these subjects in routine clinical practice. The treating physician will determine the treatment plan, as well as the frequency of laboratory and clinical assessment, if necessary, based on routine practice. All patients will be evaluated for safety during tezepelumab use (24 weeks) or within 30 days after the last administration of tezepelumab if the patients discontinued tezepelumab before 24 weeks.
Study Type
OBSERVATIONAL
Enrollment
210
Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs
Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Characterization of AEs/ADRs (nature, maximum severity, causality to tezepelumab, actions taken, and outcomes)
To describe the nature (type), severity, and causality of adverse events (AEs)/adverse drug reactions (ADRs) and actions taken to address AEs among patients receiving tezepelumab for approved indications in routine clinical practice.
Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Proportion of patients with severe asthma who show improvement in asthma control
A patient whose GINA assessment changed from "Uncontrolled" at baseline to "Partly controlled" or "Well Controlled" at end of study or from "Partly controlled" at baseline to "Well Controlled" at end of study is defined as "Improved".
Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Proportion of CRSwNP patients achieving clinically meaningful improvement in SNOT-22
Changes from baseline in SNOT-22 total scores, including the minimal clinically important difference(MCID) of 8.9 points, will be assessed to determine clinically meaningful improvement.
Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Incidence rate of AEs, ADRs, SAEs, SADRs,unexpected AEs/ADRs, unexpected SAEs/SADRs
Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
AstraZeneca Clinical Study Information Center
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