Chronic Rhinosinusitis With Nasal Polyps
Conditions
Keywords
Tezepelumab, Chronic rhinosinusitis with nasal polyps, CRSwNP, Observational Study, Patient-Reported Outcomes, Japan
Brief summary
The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)
Interventions
DRUGTezepelumab
Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 years of age or older, at the time of signing the informed consent * Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1 * Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date * Documented SNOT-22 total score\>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date) * Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1 * Physician decision that participant is eligible for treatment with tezepelumab according to local approved CRSwNP label and Optimal Clinical Use Guidelines * Patients must be able and willing to read and comprehend written instructions, to collect PROs and medication intake and to sign the informed consent document
Exclusion criteria
* Patients who participate in an interventional clinical trial in the last 4 months * Known hypersensitivity to tezepelumab or any of its excipients * Patients who have received any biologic therapy for asthma or CRSwNP * Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study * Pregnancy or lactation period or planning pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score | at 24 weeks from initiation of tezepelumab treatment. | To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score | at 4, 12, and 52 weeks from initiation of tezepelumab treatment | To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment. |
| Proportion of tezepelumab SNOT-22 responders | up to 52 weeks | Proportion of responders in sinonasal symptoms as evaluated by SNOT-22 total score, defined as patients achieving the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint. |
| Odds to achieve tezepelumab SNOT-22 response | up to 52 weeks | Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint. |
| Median time to first MCID-defined responder in sinonasal symptoms | up to 52 weeks | To describe time to response in sinonasal symptoms as evaluated by SNOT-22 total score (time from baseline to the first occurrence of ≥ 8.9-point decrease). |
| Mean change from baseline in nasal blockage (NB) measured by VAS-NB | up to 52 weeks | To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint. |
| Proportion of NB responders | up to 52 weeks | To describe proportion of NB responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline; in participants with VAS-NB ≥ 7 at baseline) at each collected timepoint. |
| Median time to meeting or exceeding the MCID for VAS-NB | up to 52 weeks | Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-NB ≥ 7 at baseline. |
| Mean change from baseline in sense of smell score by VAS-smell | up to 52 weeks | To describe changes in sense of smell as evaluated by VAS-Smell |
| Proportion of VAS-Smell responders | up to 52 weeks | Proportion of VAS-Smell responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline) in participants with VAS-Smell ≥ 7 at baseline at each collected timepoint. |
| Median time to meeting or exceeding the MCID for VAS-Smell | up to 52 weeks | Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-Smell ≥ 7 at baseline. |
| Mean change from baseline in NP severity as measured by VAS-NP symptoms | up to 52 weeks | To describe changes in NP severity (VAS-NP) at each collected timepoint. |
| Proportion of VAS-NP symptom responders | up to 52 weeks | To describe responders proportion of VAS-NP symptom responders, defined as patients achieving the MCID (≥ 2.5-point decrease from baseline) at each collected timepoint. |
| Median time to meeting or exceeding the MCID for VAS-NP symptom | up to 52 weeks | Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint. |
| Mean change from baseline in total NPS evaluated by nasal endoscopy | up to 52 weeks | To describe changes in nasal polyp score (NPS) at each collected timepoint. |
| Proportion of NPS responders | up to 52 weeks | To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline). |
| Median time to meeting or exceeding the MCID for NPS | up to 52 weeks | To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint. |
| Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question | up to 52 weeks | To describe responder proportion for NP control. |
| Median time to first attainment of NP well control or NP complete control | up to 52 weeks | To describe median time to first attainment of NP well control or NP complete control by each collected timepoint. |
| Average SCS daily dose after initiating tezepelumab | From baseline up to 24 weeks and from baseline up to 52 weeks | To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams). |
| Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use | From baseline up to 24 weeks and from baseline up to 52 weeks | To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use. |
| Number of patients with ≥ 100, 200 and 400 mg cumulative SCS | From baseline up to 24 weeks and from baseline up to 52 weeks | Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams). |
| Time-to-first disease-related SCS use | From baseline up to 24 weeks and from baseline up to 52 weeks | Time-to-first disease-related SCS use, with cumulative incidence CRSwNP-related SCS use, asthma-related SCS use, other indications related SCS use and unknown indication-related SCS use. |
| Proportion of participants with AEs, SAEs, DAEs, and AESIs | Up to 52 weeks | To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab. |
| Individual goal attainment | At Week 24 and Week 52 | Proportion of participants achieving symptoms goal: SNOT-22\* ≤ 20 |
| Composite goal attainment | At Week 24 and Week 52 | Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery |
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed