Session Type: 1-hour ePoster Review
Session Title: 1-hour ePoster Review
Authors(s): L. Ostrosky-Zeichner (1), M.H. Nguyen (2), J. Bubalo (3), B.D. Alexander (4), M.H. Miceli (5), P. Pappas (6), J. Jiang (7), Y. Song (7), G.R. Thompson (8)
Authors Affiliations(s): (1) McGovern Medical School, United States, (2) University of Pittsburgh Medical Center, United States, (3) Oregon Health and Science University Hospitals and Clinics, United States, (4) Duke University, United States, (5) University of Michigan, United States, (6) University of Alabama at Birmingham, United States, (7) Astellas Pharma Global Development, Inc, United States, (8) UC Davis Health, United States
Third Party Affiliation: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Background:
Observational registry characterising a ‘real-world’ population receiving mould-active triazoles (MATs) for the treatment or prophylaxis of invasive fungal infections (IFIs).
Methods:Multicentre, observational, prospective study of patients receiving MATs (isavuconazole, posaconazole, and voriconazole) as monotherapy, multiple therapies, or sequenced therapies for prophylaxis or treatment. Data were from 55 US centres, March 2017–April 2020. Patients were enrolled within 60 days of MAT initiation. The primary objective was to characterise patients receiving MATs and their patterns of care. Investigators assessed suspected MAT-related adverse drug reactions (ADRs). Full analysis (FAS) included patients meeting study entry criteria for the relevant enrolment protocol; safety analysis (SAF) included patients who received ≥1 MAT dose.
Results:2009 patients were enrolled (SAF); the FAS comprised 1993 (510 isavuconazole, 540 posaconazole, 491 voriconazole, 452 multiple/sequenced therapies). 816 and 1177 patients received treatment and prophylaxis, respectively. The posaconazole group reported the highest proportion of patients receiving prophylaxis 397/540 (73.5%) versus isavuconazole (256/510, 50.2%), voriconazole (272/491, 55.4%), and multiple/sequenced therapies (252/452, 55.8%). Median age was 59 (range: <1–97) years; most patients were ≥18 years (97.0%) and male (57.8%) (Table 1). Haematologic malignancy (65.0%) and neutropenia (53.9%) were the most frequent underlying diseases. Among patients with an IFI during the study, the most common pathogens were Aspergillus fumigatus in the isavuconazole (10/55 [18.2%]), voriconazole (12/47 [25.5%]), and multiple/sequenced (14/123 [11.4%]) groups, and Candida glabrata in the posaconazole group (9/43 [20.9%]); the lungs were the most common infection site (58.2%). Most patients completed their MAT therapies (1520/1915, 79.4%; Table 2), and were maintained on monotherapy (1541/1993; 77.3%). Overall, 59.1% (591/1001) patients reported a complete/partial clinical response, and no breakthrough infections were reported in 92.9% (957/1030) patients with a prophylactic assessment. ADRs were reported in the isavuconazole (3.9%), posaconazole (11.3%), voriconazole (14.2%) and multiple/sequenced (31.7%) groups (Table 3). Elevated liver function tests were the most common ADRs (7.2%).
Conclusions:This ‘real-world’ study showed that most patients completed their MAT therapy, and remained on their initial therapy. Over half of patients receiving MATs had a favourable clinical response, and breakthrough infections were rare in patients receiving MAT prophylaxis. ADRs were uncommon overall.
COI Institutional Grants: Yes
COI Other: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Session Type: 1-hour ePoster Review
Session Title: 1-hour ePoster Review
Authors(s): L. Ostrosky-Zeichner (1), M.H. Nguyen (2), J. Bubalo (3), B.D. Alexander (4), M.H. Miceli (5), P. Pappas (6), J. Jiang (7), Y. Song (7), G.R. Thompson (8)
Authors Affiliations(s): (1) McGovern Medical School, United States, (2) University of Pittsburgh Medical Center, United States, (3) Oregon Health and Science University Hospitals and Clinics, United States, (4) Duke University, United States, (5) University of Michigan, United States, (6) University of Alabama at Birmingham, United States, (7) Astellas Pharma Global Development, Inc, United States, (8) UC Davis Health, United States
Third Party Affiliation: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Background:
Observational registry characterising a ‘real-world’ population receiving mould-active triazoles (MATs) for the treatment or prophylaxis of invasive fungal infections (IFIs).
Methods:Multicentre, observational, prospective study of patients receiving MATs (isavuconazole, posaconazole, and voriconazole) as monotherapy, multiple therapies, or sequenced therapies for prophylaxis or treatment. Data were from 55 US centres, March 2017–April 2020. Patients were enrolled within 60 days of MAT initiation. The primary objective was to characterise patients receiving MATs and their patterns of care. Investigators assessed suspected MAT-related adverse drug reactions (ADRs). Full analysis (FAS) included patients meeting study entry criteria for the relevant enrolment protocol; safety analysis (SAF) included patients who received ≥1 MAT dose.
Results:2009 patients were enrolled (SAF); the FAS comprised 1993 (510 isavuconazole, 540 posaconazole, 491 voriconazole, 452 multiple/sequenced therapies). 816 and 1177 patients received treatment and prophylaxis, respectively. The posaconazole group reported the highest proportion of patients receiving prophylaxis 397/540 (73.5%) versus isavuconazole (256/510, 50.2%), voriconazole (272/491, 55.4%), and multiple/sequenced therapies (252/452, 55.8%). Median age was 59 (range: <1–97) years; most patients were ≥18 years (97.0%) and male (57.8%) (Table 1). Haematologic malignancy (65.0%) and neutropenia (53.9%) were the most frequent underlying diseases. Among patients with an IFI during the study, the most common pathogens were Aspergillus fumigatus in the isavuconazole (10/55 [18.2%]), voriconazole (12/47 [25.5%]), and multiple/sequenced (14/123 [11.4%]) groups, and Candida glabrata in the posaconazole group (9/43 [20.9%]); the lungs were the most common infection site (58.2%). Most patients completed their MAT therapies (1520/1915, 79.4%; Table 2), and were maintained on monotherapy (1541/1993; 77.3%). Overall, 59.1% (591/1001) patients reported a complete/partial clinical response, and no breakthrough infections were reported in 92.9% (957/1030) patients with a prophylactic assessment. ADRs were reported in the isavuconazole (3.9%), posaconazole (11.3%), voriconazole (14.2%) and multiple/sequenced (31.7%) groups (Table 3). Elevated liver function tests were the most common ADRs (7.2%).
Conclusions:This ‘real-world’ study showed that most patients completed their MAT therapy, and remained on their initial therapy. Over half of patients receiving MATs had a favourable clinical response, and breakthrough infections were rare in patients receiving MAT prophylaxis. ADRs were uncommon overall.
COI Institutional Grants: Yes
COI Other: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Session Type: 1-hour ePoster Review
Session Title: 1-hour ePoster Review
Authors(s): L. Ostrosky-Zeichner (1), M.H. Nguyen (2), J. Bubalo (3), B.D. Alexander (4), M.H. Miceli (5), P. Pappas (6), J. Jiang (7), Y. Song (7), G.R. Thompson (8)
Authors Affiliations(s): (1) McGovern Medical School, United States, (2) University of Pittsburgh Medical Center, United States, (3) Oregon Health and Science University Hospitals and Clinics, United States, (4) Duke University, United States, (5) University of Michigan, United States, (6) University of Alabama at Birmingham, United States, (7) Astellas Pharma Global Development, Inc, United States, (8) UC Davis Health, United States
Third Party Affiliation: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Background:
Observational registry characterising a ‘real-world’ population receiving mould-active triazoles (MATs) for the treatment or prophylaxis of invasive fungal infections (IFIs).
Methods:Multicentre, observational, prospective study of patients receiving MATs (isavuconazole, posaconazole, and voriconazole) as monotherapy, multiple therapies, or sequenced therapies for prophylaxis or treatment. Data were from 55 US centres, March 2017–April 2020. Patients were enrolled within 60 days of MAT initiation. The primary objective was to characterise patients receiving MATs and their patterns of care. Investigators assessed suspected MAT-related adverse drug reactions (ADRs). Full analysis (FAS) included patients meeting study entry criteria for the relevant enrolment protocol; safety analysis (SAF) included patients who received ≥1 MAT dose.
Results:2009 patients were enrolled (SAF); the FAS comprised 1993 (510 isavuconazole, 540 posaconazole, 491 voriconazole, 452 multiple/sequenced therapies). 816 and 1177 patients received treatment and prophylaxis, respectively. The posaconazole group reported the highest proportion of patients receiving prophylaxis 397/540 (73.5%) versus isavuconazole (256/510, 50.2%), voriconazole (272/491, 55.4%), and multiple/sequenced therapies (252/452, 55.8%). Median age was 59 (range: <1–97) years; most patients were ≥18 years (97.0%) and male (57.8%) (Table 1). Haematologic malignancy (65.0%) and neutropenia (53.9%) were the most frequent underlying diseases. Among patients with an IFI during the study, the most common pathogens were Aspergillus fumigatus in the isavuconazole (10/55 [18.2%]), voriconazole (12/47 [25.5%]), and multiple/sequenced (14/123 [11.4%]) groups, and Candida glabrata in the posaconazole group (9/43 [20.9%]); the lungs were the most common infection site (58.2%). Most patients completed their MAT therapies (1520/1915, 79.4%; Table 2), and were maintained on monotherapy (1541/1993; 77.3%). Overall, 59.1% (591/1001) patients reported a complete/partial clinical response, and no breakthrough infections were reported in 92.9% (957/1030) patients with a prophylactic assessment. ADRs were reported in the isavuconazole (3.9%), posaconazole (11.3%), voriconazole (14.2%) and multiple/sequenced (31.7%) groups (Table 3). Elevated liver function tests were the most common ADRs (7.2%).
Conclusions:This ‘real-world’ study showed that most patients completed their MAT therapy, and remained on their initial therapy. Over half of patients receiving MATs had a favourable clinical response, and breakthrough infections were rare in patients receiving MAT prophylaxis. ADRs were uncommon overall.
COI Institutional Grants: Yes
COI Other: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Session Type: 1-hour ePoster Review
Session Title: 1-hour ePoster Review
Authors(s): L. Ostrosky-Zeichner (1), M.H. Nguyen (2), J. Bubalo (3), B.D. Alexander (4), M.H. Miceli (5), P. Pappas (6), J. Jiang (7), Y. Song (7), G.R. Thompson (8)
Authors Affiliations(s): (1) McGovern Medical School, United States, (2) University of Pittsburgh Medical Center, United States, (3) Oregon Health and Science University Hospitals and Clinics, United States, (4) Duke University, United States, (5) University of Michigan, United States, (6) University of Alabama at Birmingham, United States, (7) Astellas Pharma Global Development, Inc, United States, (8) UC Davis Health, United States
Third Party Affiliation: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.
Background:
Observational registry characterising a ‘real-world’ population receiving mould-active triazoles (MATs) for the treatment or prophylaxis of invasive fungal infections (IFIs).
Methods:Multicentre, observational, prospective study of patients receiving MATs (isavuconazole, posaconazole, and voriconazole) as monotherapy, multiple therapies, or sequenced therapies for prophylaxis or treatment. Data were from 55 US centres, March 2017–April 2020. Patients were enrolled within 60 days of MAT initiation. The primary objective was to characterise patients receiving MATs and their patterns of care. Investigators assessed suspected MAT-related adverse drug reactions (ADRs). Full analysis (FAS) included patients meeting study entry criteria for the relevant enrolment protocol; safety analysis (SAF) included patients who received ≥1 MAT dose.
Results:2009 patients were enrolled (SAF); the FAS comprised 1993 (510 isavuconazole, 540 posaconazole, 491 voriconazole, 452 multiple/sequenced therapies). 816 and 1177 patients received treatment and prophylaxis, respectively. The posaconazole group reported the highest proportion of patients receiving prophylaxis 397/540 (73.5%) versus isavuconazole (256/510, 50.2%), voriconazole (272/491, 55.4%), and multiple/sequenced therapies (252/452, 55.8%). Median age was 59 (range: <1–97) years; most patients were ≥18 years (97.0%) and male (57.8%) (Table 1). Haematologic malignancy (65.0%) and neutropenia (53.9%) were the most frequent underlying diseases. Among patients with an IFI during the study, the most common pathogens were Aspergillus fumigatus in the isavuconazole (10/55 [18.2%]), voriconazole (12/47 [25.5%]), and multiple/sequenced (14/123 [11.4%]) groups, and Candida glabrata in the posaconazole group (9/43 [20.9%]); the lungs were the most common infection site (58.2%). Most patients completed their MAT therapies (1520/1915, 79.4%; Table 2), and were maintained on monotherapy (1541/1993; 77.3%). Overall, 59.1% (591/1001) patients reported a complete/partial clinical response, and no breakthrough infections were reported in 92.9% (957/1030) patients with a prophylactic assessment. ADRs were reported in the isavuconazole (3.9%), posaconazole (11.3%), voriconazole (14.2%) and multiple/sequenced (31.7%) groups (Table 3). Elevated liver function tests were the most common ADRs (7.2%).
Conclusions:This ‘real-world’ study showed that most patients completed their MAT therapy, and remained on their initial therapy. Over half of patients receiving MATs had a favourable clinical response, and breakthrough infections were rare in patients receiving MAT prophylaxis. ADRs were uncommon overall.
COI Institutional Grants: Yes
COI Other: The study was sponsored by Astellas Pharma Global Development, Inc. Medical writing support was provided by Anne-Marie Edwards, MChem, of Cello Health MedErgy, funded by Astellas Pharma Global Development, Inc.