Real-life use of delamanid: results from the European post-authorisation safety study
BACKGROUND: A post-authorisation safety study (PASS) on delamanid (DLM) was conducted as part of a post-approval commitment to the European Medicines Agency. The aim of this study was to evaluate the use of DLM in a real-life setting, its safety, and treatment outcomes in patients with multidrug-res...
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International Union Against Tuberculosis and Lung Disease (The Union)
2024-06-01
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| Series: | IJTLD Open |
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| Online Access: | https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2024/00000001/00000006/art00006 |
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| author | N. Schönfeld L. Barkane I. Davoliene M. Danilovits S. Miliauskas F. Ader O.M. Kon C. Lange A. Duvignaud M. Heiss-Neumann N. Hittel N. Lazarević I. Knebel A. Martin B. Eschenbach E. van Heumen V. George |
| author_facet | N. Schönfeld L. Barkane I. Davoliene M. Danilovits S. Miliauskas F. Ader O.M. Kon C. Lange A. Duvignaud M. Heiss-Neumann N. Hittel N. Lazarević I. Knebel A. Martin B. Eschenbach E. van Heumen V. George |
| author_sort | N. Schönfeld |
| collection | DOAJ |
| description | BACKGROUND: A post-authorisation safety study (PASS) on delamanid (DLM) was conducted as part of a post-approval commitment to the European Medicines Agency. The aim of this study was to evaluate the use of DLM in a real-life setting, its safety, and treatment outcomes in patients with multidrug-resistant TB (MDR-TB).METHODS: This was a prospective, multicentric, non-interventional study conducted in the European Union. MDR-TB Regimen selection and patient monitoring were conducted in accordance with existing medical practices. Data on the use of DLM, related adverse events, and treatment outcomes were collected for up to 30 months after the first DLM dose. Descriptive summary statistics were used for continuous and categorical variables.RESULTS: Out of 86 patients, one had extrapulmonary TB. Two-thirds of the patients were treated with DLM for more than 24 weeks. The most frequent adverse drug reaction to DLM was QT interval prolongation. Resistance to DLM was detected in one patient during treatment. The treatment success rate was 77%.CONCLUSION: No new safety concerns were revealed, including in patients treated with DLM for more than 24 weeks. QT interval prolongations were well managed and did not lead to any clinically significant cardiac effects. The treatment outcomes were in line with the WHO target for Europe. |
| format | Article |
| id | doaj-art-012d585edc80495abb2f1cf7c1697488 |
| institution | Kabale University |
| issn | 3005-7590 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | International Union Against Tuberculosis and Lung Disease (The Union) |
| record_format | Article |
| series | IJTLD Open |
| spelling | doaj-art-012d585edc80495abb2f1cf7c16974882025-01-21T10:44:17ZengInternational Union Against Tuberculosis and Lung Disease (The Union)IJTLD Open3005-75902024-06-011627427810.5588/ijtldopen.24.01136Real-life use of delamanid: results from the European post-authorisation safety studyN. Schönfeld0L. Barkane1I. Davoliene2M. Danilovits3S. Miliauskas4F. Ader5O.M. Kon6C. Lange7A. Duvignaud8M. Heiss-Neumann9N. Hittel10N. Lazarević11I. Knebel12A. Martin13B. Eschenbach14E. van Heumen15V. George16Helios Klinikum Emil von Behring, Berlin, Germany;Riga East University Hospital, Riga, Latvia;Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania;Tartu University Hospital, Tartu, Estonia;Department of Pulmonology, Lithuania University of Health Sciences, Kaunas, Lithuania;Hospices Civils de Lyon, Département des Maladies Infectieuses et Tropicales, Lyon, France;Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK;Research Center Borstel, Leibniz Lung Center, Borstel, Germany;Department of Infectious Diseases and Tropical Medicine, Centre Hospitalier Universitaire de Bordeaux-Groupe Hospitalier Pellegrin, Bordeaux, France;Asklepios Fachkliniken München-Gauting, Gauting, Germany;Otsuka Novel Products, Munich, Germany;Otsuka Novel Products, Munich, Germany;Otsuka Novel Products, Munich, Germany;Otsuka Novel Products, Munich, Germany;Otsuka Pharma, Frankfurt, Germany;Otsuka Pharma, Frankfurt, Germany;Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ, USA.BACKGROUND: A post-authorisation safety study (PASS) on delamanid (DLM) was conducted as part of a post-approval commitment to the European Medicines Agency. The aim of this study was to evaluate the use of DLM in a real-life setting, its safety, and treatment outcomes in patients with multidrug-resistant TB (MDR-TB).METHODS: This was a prospective, multicentric, non-interventional study conducted in the European Union. MDR-TB Regimen selection and patient monitoring were conducted in accordance with existing medical practices. Data on the use of DLM, related adverse events, and treatment outcomes were collected for up to 30 months after the first DLM dose. Descriptive summary statistics were used for continuous and categorical variables.RESULTS: Out of 86 patients, one had extrapulmonary TB. Two-thirds of the patients were treated with DLM for more than 24 weeks. The most frequent adverse drug reaction to DLM was QT interval prolongation. Resistance to DLM was detected in one patient during treatment. The treatment success rate was 77%.CONCLUSION: No new safety concerns were revealed, including in patients treated with DLM for more than 24 weeks. QT interval prolongations were well managed and did not lead to any clinically significant cardiac effects. The treatment outcomes were in line with the WHO target for Europe.https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2024/00000001/00000006/art00006tuberculosismultidrug-resistant tuberculosismdr-tbpasssafety treatment outcomesadverse eventseuropean medicines agency |
| spellingShingle | N. Schönfeld L. Barkane I. Davoliene M. Danilovits S. Miliauskas F. Ader O.M. Kon C. Lange A. Duvignaud M. Heiss-Neumann N. Hittel N. Lazarević I. Knebel A. Martin B. Eschenbach E. van Heumen V. George Real-life use of delamanid: results from the European post-authorisation safety study IJTLD Open tuberculosis multidrug-resistant tuberculosis mdr-tb pass safety treatment outcomes adverse events european medicines agency |
| title | Real-life use of delamanid: results from the European post-authorisation safety study |
| title_full | Real-life use of delamanid: results from the European post-authorisation safety study |
| title_fullStr | Real-life use of delamanid: results from the European post-authorisation safety study |
| title_full_unstemmed | Real-life use of delamanid: results from the European post-authorisation safety study |
| title_short | Real-life use of delamanid: results from the European post-authorisation safety study |
| title_sort | real life use of delamanid results from the european post authorisation safety study |
| topic | tuberculosis multidrug-resistant tuberculosis mdr-tb pass safety treatment outcomes adverse events european medicines agency |
| url | https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2024/00000001/00000006/art00006 |
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