ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab (ANANKE)

ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Severe Asthma
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 217

Contacts and Locations

Study Locations

• Italy
  • Acquaviva delle Fonti, Italy
    • Research Site
  • Bergamo, Italy
    • Research Site
  • Cassano Murge, Italy
    • Research Site
  • Catanzaro, Italy
    • Research Site
  • Firenze, Italy
    • Research Site
  • Foggia, Italy
    • Research Site
  • Garbagnate Milanese, Italy
    • Research Site
  • Milano, Italy
    • Research Site
  • Monserrato, Italy
    • Research Site
  • Napoli, 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
2. Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment).
3. Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice.
4. Patients who signed the informed consent and privacy form at enrollment visit.
5. Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").

Exclusion Criteria:

1. Patients who, during the observation period, received benralizumab in a clinical experimental trial.
2. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: 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, 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D3250R00073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD