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Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany
PURPOSE: Many patients treated for ulcerative colitis (UC) do not achieve clinical remission. This real-world study assessed clinical remission and inadequate response rates among patients with UC in Germany treated with advanced therapies. METHODS: This retrospective chart review included patients...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10164668/ https://www.ncbi.nlm.nih.gov/pubmed/37150784 http://dx.doi.org/10.1007/s00384-023-04397-7 |
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author | Bokemeyer, Bernd Picker, Nils Kromer, Daniel Rosin, Ludger Patel, Haridarshan |
author_facet | Bokemeyer, Bernd Picker, Nils Kromer, Daniel Rosin, Ludger Patel, Haridarshan |
author_sort | Bokemeyer, Bernd |
collection | PubMed |
description | PURPOSE: Many patients treated for ulcerative colitis (UC) do not achieve clinical remission. This real-world study assessed clinical remission and inadequate response rates among patients with UC in Germany treated with advanced therapies. METHODS: This retrospective chart review included patients with UC newly initiating advanced (index) therapy (anti-TNFα agents, vedolizumab, tofacitinib) from January 2017–September 2019 (index date). Included patients had data for ≥ 12 months before (baseline period) and after the index date (follow-up period). Remission was defined as a partial Mayo score ≤ 1. Indicators of inadequate response were: index therapy discontinuation; therapy adjustments (index therapy dose escalation; augmentation with non-advanced therapies; corticosteroid [CS] use during maintenance therapy); CS dependency (use for ≥ 12 weeks); and UC-related hospitalisation, surgery or emergency department visit. Time to first remission and inadequate response were analyzed using Kaplan–Meier analyses. RESULTS: Among 149 patients with UC (median age: 40 years), 96 (64.4%) were biologic-naïve and 42 (28.2%) received CS at the index date. Within 12 months, 52 patients (47.2%) were in remission; of these, 13 patients (25.0%) received ≥ 1 therapy adjustment. At 12 months, 55 patients (37.6%) had ≥ 1 indicator of an inadequate response. Median time to remission was longer among biologic-experienced vs biologic-naïve patients (24 vs 7 months; p = 0.012). CONCLUSION: Over half of the patients were not in clinical remission after 12 months and more than one-third experienced inadequate response. One-quarter of patients in remission required therapy adjustments. Patients with UC require therapies that are more effective than those currently available to achieve better treatment outcomes. SUPPLEMENTARY INFORMATION: The online version contains supplementary information available at 10.1007/s00384-023-04397-7. |
format | Online Article Text |
id | pubmed-10164668 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-101646682023-05-09 Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany Bokemeyer, Bernd Picker, Nils Kromer, Daniel Rosin, Ludger Patel, Haridarshan Int J Colorectal Dis Research PURPOSE: Many patients treated for ulcerative colitis (UC) do not achieve clinical remission. This real-world study assessed clinical remission and inadequate response rates among patients with UC in Germany treated with advanced therapies. METHODS: This retrospective chart review included patients with UC newly initiating advanced (index) therapy (anti-TNFα agents, vedolizumab, tofacitinib) from January 2017–September 2019 (index date). Included patients had data for ≥ 12 months before (baseline period) and after the index date (follow-up period). Remission was defined as a partial Mayo score ≤ 1. Indicators of inadequate response were: index therapy discontinuation; therapy adjustments (index therapy dose escalation; augmentation with non-advanced therapies; corticosteroid [CS] use during maintenance therapy); CS dependency (use for ≥ 12 weeks); and UC-related hospitalisation, surgery or emergency department visit. Time to first remission and inadequate response were analyzed using Kaplan–Meier analyses. RESULTS: Among 149 patients with UC (median age: 40 years), 96 (64.4%) were biologic-naïve and 42 (28.2%) received CS at the index date. Within 12 months, 52 patients (47.2%) were in remission; of these, 13 patients (25.0%) received ≥ 1 therapy adjustment. At 12 months, 55 patients (37.6%) had ≥ 1 indicator of an inadequate response. Median time to remission was longer among biologic-experienced vs biologic-naïve patients (24 vs 7 months; p = 0.012). CONCLUSION: Over half of the patients were not in clinical remission after 12 months and more than one-third experienced inadequate response. One-quarter of patients in remission required therapy adjustments. Patients with UC require therapies that are more effective than those currently available to achieve better treatment outcomes. SUPPLEMENTARY INFORMATION: The online version contains supplementary information available at 10.1007/s00384-023-04397-7. Springer Berlin Heidelberg 2023-05-08 2023 /pmc/articles/PMC10164668/ /pubmed/37150784 http://dx.doi.org/10.1007/s00384-023-04397-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Research Bokemeyer, Bernd Picker, Nils Kromer, Daniel Rosin, Ludger Patel, Haridarshan Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany |
title | Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany |
title_full | Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany |
title_fullStr | Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany |
title_full_unstemmed | Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany |
title_short | Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany |
title_sort | rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in germany |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10164668/ https://www.ncbi.nlm.nih.gov/pubmed/37150784 http://dx.doi.org/10.1007/s00384-023-04397-7 |
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