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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs | 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. | Baseline to Week 24 or 30 days after last dose if discontinued earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Baseline to Week 24 or 30 days after last dose if discontinued earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence proportion of AEs by demographic and clinical characteristics | Baseline to Week 24 or 30 days after last dose if discontinued earlier. | |
| Proportion of patients with improved asthma control by demographic and clinical characteristics | Proportion achieving "improved" GINA control (as defined above) summarized within prespecified subgroups (demographics, baseline clinical characteristics), with exact 95% CIs. |
Inclusion Criteria:
Exclusion Criteria:
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Study Population:
The study population will consist of adolescent and adult patients with a diagnosis of severe asthma or CRSwNP who are receiving tezepelumab according to its approved indication by MFDS. Eligible patients will be enrolled by a continuous registration method.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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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.
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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.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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. | 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 | Baseline to Week 24 or 30 days after last dose if discontinued earlier. |
| Baseline to Week 24 or 30 days after last dose if discontinued earlier. |
| Proportion of patients with clinically meaningful improvement in SNOT-22 scores by demographic and clinical characteristics | Proportion of SNOT-22 responders (≥8.9-point reduction) summarized within prespecified subgroups (demographics, baseline clinical characteristics), with exact 95% CIs. | Baseline to Week 24 or 30 days after last dose if discontinued earlier. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |