Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019)
Abstract Introduction Real-world data from multinational observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe. Methods A retrospective medical record review was conducted at 16 sites in Europe (France, Germany, Italy, Spai...
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Adis, Springer Healthcare
2024-10-01
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| Series: | Infectious Diseases and Therapy |
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| Online Access: | https://doi.org/10.1007/s40121-024-01064-4 |
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| author | Dionysios Neofytos Antonio Pagliuca Katherine Houghton Edward Broughton Maria Lavinea Novis de Figueiredo Valente Lili Jiang David A. Enoch Beate Gruener Raoul Herbrecht Tobias Lahmer Olivier Lortholary Cléa Melenotte Francesco Giuseppe De Rosa Carolina Garcia-Vidal Maria Jimenez Maria Fernandez Oliver Cornely |
| author_facet | Dionysios Neofytos Antonio Pagliuca Katherine Houghton Edward Broughton Maria Lavinea Novis de Figueiredo Valente Lili Jiang David A. Enoch Beate Gruener Raoul Herbrecht Tobias Lahmer Olivier Lortholary Cléa Melenotte Francesco Giuseppe De Rosa Carolina Garcia-Vidal Maria Jimenez Maria Fernandez Oliver Cornely |
| author_sort | Dionysios Neofytos |
| collection | DOAJ |
| description | Abstract Introduction Real-world data from multinational observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe. Methods A retrospective medical record review was conducted at 16 sites in Europe (France, Germany, Italy, Spain, and the United Kingdom). Eligible records were from patients aged ≥ 18 years at the time of isavuconazole initiation and received at least one dose of isavuconazole for suspected or confirmed invasive aspergillosis (IA) or invasive mucormycosis (IM) during the eligibility period (October 15, 2015 to June 30, 2019). Data were descriptively analysed. Success rates, overall survival, and times to these events were descriptively analysed. Results Data were abstracted from 218 patients (201, IA; 17, IM) who received isavuconazole as monotherapy (initiated as infusion, 52%; oral, 46%). Isavuconazole was initiated as primary therapy in 92 patients (42.2%) and salvage therapy in 121 patients (55.5%) (unknown for five patients). Mean (standard deviation) age was 56.8 (15.6) years, 66% were men and 62% had at least three comorbidities, most frequently haematologic malignancy (62%). Estimated clinical response rate at week 24 was 54.5% (95% confidence interval [CI], 38.2–66.5%) for primary treatment and 73.5% (95% CI, 62.7–81.1%) for salvage therapy. Overall, 45 patients (21%) experienced at least one adverse event (AE). Serious AEs were experienced by 37 patients (17%), with seven related to isavuconazole; five patients (2.3%) discontinued isavuconazole monotherapy due to the serious AE. A total of 137 patients (63%) died, with 17 deaths (12.4%) related to their invasive fungal infection, 11 of whom initiated isavuconazole as salvage therapy. Conclusions This study adds to the growing body of evidence that whether used as first-line therapy or after the failure of other antifungal therapies, isavuconazole appears to have a promising clinical response and a good safety profile as an antifungal agent in patients with varied underlying conditions. |
| format | Article |
| id | doaj-art-9b10fd1567e64a35a1de7973908702ef |
| institution | Kabale University |
| issn | 2193-8229 2193-6382 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Adis, Springer Healthcare |
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| series | Infectious Diseases and Therapy |
| spelling | doaj-art-9b10fd1567e64a35a1de7973908702ef2024-11-24T12:36:58ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822024-10-0113122527254310.1007/s40121-024-01064-4Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019)Dionysios Neofytos0Antonio Pagliuca1Katherine Houghton2Edward Broughton3Maria Lavinea Novis de Figueiredo Valente4Lili Jiang5David A. Enoch6Beate Gruener7Raoul Herbrecht8Tobias Lahmer9Olivier Lortholary10Cléa Melenotte11Francesco Giuseppe De Rosa12Carolina Garcia-Vidal13Maria Jimenez14Maria Fernandez15Oliver Cornely16Geneva University HospitalsKing’s College LondonRTI Health SolutionsPfizer Inc.Pfizer Inc.Pfizer Inc.Cambridge University Hospital NHS Foundation TrustUniversity Hospital of UlmInstitut de Cancérologie Strasbourg Europe (ICANS), University of StrasbourgTechnical University of MunichCentre National de Référence Mycoses Invasives et Antifongiques, Necker Enfants Malades University Hospital and Institut PasteurNecker Enfants Malades University HospitalUniversity of TurinHospital Clinic BarcelonaRTI Health SolutionsPfizer Inc.University of CologneAbstract Introduction Real-world data from multinational observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe. Methods A retrospective medical record review was conducted at 16 sites in Europe (France, Germany, Italy, Spain, and the United Kingdom). Eligible records were from patients aged ≥ 18 years at the time of isavuconazole initiation and received at least one dose of isavuconazole for suspected or confirmed invasive aspergillosis (IA) or invasive mucormycosis (IM) during the eligibility period (October 15, 2015 to June 30, 2019). Data were descriptively analysed. Success rates, overall survival, and times to these events were descriptively analysed. Results Data were abstracted from 218 patients (201, IA; 17, IM) who received isavuconazole as monotherapy (initiated as infusion, 52%; oral, 46%). Isavuconazole was initiated as primary therapy in 92 patients (42.2%) and salvage therapy in 121 patients (55.5%) (unknown for five patients). Mean (standard deviation) age was 56.8 (15.6) years, 66% were men and 62% had at least three comorbidities, most frequently haematologic malignancy (62%). Estimated clinical response rate at week 24 was 54.5% (95% confidence interval [CI], 38.2–66.5%) for primary treatment and 73.5% (95% CI, 62.7–81.1%) for salvage therapy. Overall, 45 patients (21%) experienced at least one adverse event (AE). Serious AEs were experienced by 37 patients (17%), with seven related to isavuconazole; five patients (2.3%) discontinued isavuconazole monotherapy due to the serious AE. A total of 137 patients (63%) died, with 17 deaths (12.4%) related to their invasive fungal infection, 11 of whom initiated isavuconazole as salvage therapy. Conclusions This study adds to the growing body of evidence that whether used as first-line therapy or after the failure of other antifungal therapies, isavuconazole appears to have a promising clinical response and a good safety profile as an antifungal agent in patients with varied underlying conditions.https://doi.org/10.1007/s40121-024-01064-4Invasive aspergillosisInvasive mucormycosisIsavuconazoleReal-world evidence |
| spellingShingle | Dionysios Neofytos Antonio Pagliuca Katherine Houghton Edward Broughton Maria Lavinea Novis de Figueiredo Valente Lili Jiang David A. Enoch Beate Gruener Raoul Herbrecht Tobias Lahmer Olivier Lortholary Cléa Melenotte Francesco Giuseppe De Rosa Carolina Garcia-Vidal Maria Jimenez Maria Fernandez Oliver Cornely Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019) Infectious Diseases and Therapy Invasive aspergillosis Invasive mucormycosis Isavuconazole Real-world evidence |
| title | Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019) |
| title_full | Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019) |
| title_fullStr | Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019) |
| title_full_unstemmed | Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019) |
| title_short | Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015–2019) |
| title_sort | effectiveness safety and patterns of real world isavuconazole use in europe 2015 2019 |
| topic | Invasive aspergillosis Invasive mucormycosis Isavuconazole Real-world evidence |
| url | https://doi.org/10.1007/s40121-024-01064-4 |
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