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This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.
A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Patients currently in treatment with benralizumab as per approved indication and clinical practice |
| Measure | Description | Time Frame |
|---|---|---|
| key features at benralizumab treatment start) | Total IgE and eosinophils count in peripheral blood as measured at index date Lung function assessments Presence of comorbidities Previous severe exacerbations in the 12 months before index date. Previous treatments with biologics for asthma before index date. Maintenance asthma treatment(s) ongoing at index date. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| severe exacerbations during benralizumab treatment | Proportion of patients experiencing at least 1 severe exacerbation during benralizumab treatment. Severe exacerbation incidence rate during benralizumab treatment, calculated as the number of patients with at least one exacerbation occurred during benralizumab treatment (cases) divided by the person-time at risk considering the duration of observation while the patient was receiving benralizumab. Annual severe exacerbation rate, which will be calculated as the ratio between the total number of severe exacerbations occurred in the sample and the total number of person-years (i.e. the actual time-at-risk that all evaluable patients contributed to the study while they were in treatment with benralizumab). |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll patients with severe eosinophilic asthma treated with benralizumab. Patients can be enrolled if they received benralizumab either within the sampling program or as per routine clinical practice.
Participating sites will enroll patients in a consecutive manner when patients come for their regular visit, in order to minimize the risk of selection bias.
A total of 200 patients are expected to be included in the study by around 20 sites, corresponding to approximately 10 patients/site: it is estimated that the study will enroll approximately 25 patients per month in the around 20 centers involved (approximately 1.3 patients/month/center). This target sample size is expected to be reached durin
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| Name | Affiliation | Role |
|---|---|---|
| Girolamo Pelaia, MD | Università degli Studi Magna Graecia | Principal Investigator |
| Pietro Bracciale, MD | Ospedale di Ostuni | Principal Investigator |
| Francesco Menzella, MD | Arcispedale Santa Maria Nuova, Reggio Emilia | Principal Investigator |
| Giorgio W Canonica, MD | Humanitas University Rozzano | Principal Investigator |
| Andrea Matucci, MD | AO Careggi Firenze | Principal Investigator |
| Mariella D'Amato, MD | AO Dei Colli Monaldi Napoli | Principal Investigator |
| Elisabetta Romagnoli, MD | Treviso Regional Hospital | Principal Investigator |
| Fausto De Michele, MD | AO Cardarelli Napoli | Principal Investigator |
| Paolo Palange, MD | Policlinico Umberto I Roma | Principal Investigator |
| Adriano Vaghi, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Acquaviva delle Fonti | Italy | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39287158 | Derived | Canonica GW, Consani L, Malerba L, Pelaia G, Vultaggio A; ANANKE investigators. Effects of benralizumab in patients with severe eosinophilic asthma (SEA): A plain language summary of the ANANKE study. Immunotherapy. 2024;16(14-15):913-923. doi: 10.1080/1750743X.2024.2386899. Epub 2024 Sep 17. | |
| 37210543 | Derived |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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No plan to share IPD
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| at 16 weeks |
| ICS and OCS change during benralizumab treatment | ICS dose change of any extent Change of OCS dose (final dose* with respect to index date; if applicable) | at 16 weeks |
| IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start | Descriptive statistics of total IgE and eosinophils count in peripheral blood as measured at the time points specified. Descriptive statistics of intra-patient changes over time in total IgE and eosinophils count in peripheral blood, at each time points specified with respect to index date (according to data availability). | at 16 weeks |
| lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start | Descriptive statistics of lung function parameters as measured at the time points specified. Descriptive statistics of intra-patient changes over time in lung function parameters, at each time points specified with respect to index date (according to data availability). | at 16 weeks |
| patients' asthma control level and quality of life at benralizumab treatment start, during the observation period, and changes over time with respect to benralizumab treatment start | Descriptive statistics of Asthma Control Test (ACT) total score at index date (if available). Descriptive statistics of ACT total score at the time points specified in chapter 4.2 (according to data availability), along with proportion of patients with well-controlled asthma (i.e. ACT score major of 20). Descriptive statistics of intra-patient changes in ACT total score, at each time points specified in chapter 4.2 with respect to index date (according to data availability). Descriptive statistics of Asthma Quality of Life Questionnaire (AQLQ) total score at index date (if available). Descriptive statistics of AQLQ total score at the time points specified in chapter 4.2 (according to data availability). Descriptive statistics of intra-patient changes in AQLQ total score, at each time points specified in chapter 4.2 with respect to index date (according to data availability). | at 16 weeks |
| patient's adherence to benralizumab treatment | Descriptive statistics of level of patient's adherence to benralizumab treatment, computed as the ratio (in percentage) between the number of actual injections received during the observation period over the number of expected injections (which will be estimated considering the injection schedulation specified in the SmPC). | at 16 weeks |
| healthcare resource utilization during benralizumab treatment | Descriptive statistics of total number (per patient) of the following healthcare resource utilization occurred during benralizumab treatment: GP/specialist visits for asthma, ER admissions for asthma, and hospitalizations for asthma. | at 16 weeks |
| benralizumab discontinuation | Proportion of patients with benralizumab permanent discontinuation during the observation period, and description of reasons. | at 16 weeks |
| biologic treatments during the observation period | Proportion of patients with subsequent biologic treatments for asthma, and description of type of treatment and reason for switch | at 16 weeks |
| AO Garbagnate Milanese |
| Principal Investigator |
| Pietro Schino, MD | Ospedale Miulli, Acquaviva delle Fonti | Principal Investigator |
| Paola Rogliani, MD | University of Rome Tor Vergata | Principal Investigator |
| Elena Bargagli, MD | Policlinico Le Scotte Siena | Principal Investigator |
| Stefano Centanni, MD | Ospedale San Paolo Milano | Principal Investigator |
| Cristiano Caruso, MD | IRCCS Fondazione Gemelli Roma | Principal Investigator |
| Stefano Del Giacco, MD | Ospedale Monserrato Cagliari | Principal Investigator |
| Maria Aliani, MD | IRCCS Maugeri Cassano delle Murge | Principal Investigator |
| Diego Bagnasco, MD | IRCCS San Martino Genova | Principal Investigator |
| Antonino Musarra, MD | Casa della Salute Scilla | Principal Investigator |
| Fabiano Di Marco, MD | Ospedale Papa Giovanni XXIII Bergamo | Principal Investigator |
| Gianenrico Senna, MD | Ospedale Borgo Trento - Verona | Principal Investigator |
| Luigi Macchia, MD | Policlinico Bari | Principal Investigator |
| Bergamo |
| Italy |
| Research Site | Cassano Murge | Italy |
| Research Site | Catanzaro | Italy |
| Research Site | Florence | Italy |
| Research Site | Foggia | Italy |
| Research Site | Garbagnate Milanese | Italy |
| Research Site | Milan | Italy |
| Research Site | Monserrato | Italy |
| Research Site | Naples | Italy |
| Research Site | Ostuni | Italy |
| Research Site | Reggio Emilia | Italy |
| Research Site | Roma | Italy |
| Research Site | Rozzano | Italy |
| Research Site | Siena | Italy |
| Research Site | Torino | Italy |
| Research Site | Treviso | Italy |
| Research Site | Verona | Italy |
| Vultaggio A, Aliani M, Altieri E, Bracciale P, Brussino L, Caiaffa MF, Cameli P, Canonica GW, Caruso C, Centanni S, D'Amato M, De Michele F, Del Giacco S, Di Marco F, Menzella F, Pelaia G, Rogliani P, Romagnoli M, Schino P, Senna G, Benci M, Boarino S, Schroeder JW. Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study. Respir Res. 2023 May 20;24(1):135. doi: 10.1186/s12931-023-02439-w. |
| 35183167 | Derived | Menzella F, Bargagli E, Aliani M, Bracciale P, Brussino L, Caiaffa MF, Caruso C, Centanni S, D'Amato M, Del Giacco S, De Michele F, Di Marco F, Pastorello EA, Pelaia G, Rogliani P, Romagnoli M, Schino P, Senna G, Vultaggio A, Simoni L, Ori A, Boarino S, Vitiello G, Altieri E, Canonica GW. ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. Respir Res. 2022 Feb 19;23(1):36. doi: 10.1186/s12931-022-01952-8. |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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