Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study
The non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing–remitting MS (TREAT-MS) study collects the so far largest real-life cohort regarding utilization, long-term effectiveness, and safety of alemtuzumab, a humanized monoclonal antibody directed agai...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-08-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2021.620758/full |
| _version_ | 1818599572253966336 |
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| author | Tjalf Ziemssen Frank Hoffmann Stephan Richter Ulrich Engelmann Robin White |
| author_facet | Tjalf Ziemssen Frank Hoffmann Stephan Richter Ulrich Engelmann Robin White |
| author_sort | Tjalf Ziemssen |
| collection | DOAJ |
| description | The non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing–remitting MS (TREAT-MS) study collects the so far largest real-life cohort regarding utilization, long-term effectiveness, and safety of alemtuzumab, a humanized monoclonal antibody directed against the cell surface glycoprotein CD52, in adult patients with active relapsing–remitting multiple sclerosis (RRMS). An interim analysis of baseline parameters at inclusion of a non-interventional real-world study about alemtuzumab in Germany including previous multiple sclerosis (MS) medication utilization, MS activity, severity, and duration, as well as comorbidities was performed. Of the 883 patients, 71.6% were women. Mean age was 35.7 ± 9.2 years, time since first MS symptoms (=disease duration) is 8.0 ± 6.8 years, and Expanded Disability Status Scale (EDSS) is 2.7 ± 1.8 points (range, 0.0–7.5 points). The number of relapses in the 12 and 24 months prior to inclusion were 1.6 ± 1.2 and 2.2 ± 1.8, respectively. Of the patients, 14.4% were treatment naive, while for the majority, a wide spectrum of MS disease-modifying treatments (DMTs) and treatment sequences were documented. Overall, interferon beta (IFN-beta) was reported most frequently (52.4%), followed by fingolimod (35.2%), natalizumab (34.9%), and glatiramer acetate (28.9%). Patients with longer disease duration and higher EDSS had a higher number of previous DMTs. Compared to the pivotal phase 2/3 studies, RRMS patients starting alemtuzumab treatment had a longer disease duration in real-world conditions. There was variety of different treatment sequences before the final switch to alemtuzumab. In the future, linking these treatment sequences or other baseline characteristics with effectiveness and safety outcomes might be useful to support treatment decisions. Registered at Paul-Ehrlich-Institut under NIS 281. |
| first_indexed | 2024-12-16T12:21:43Z |
| format | Article |
| id | doaj.art-d7fe2c76fdf646759d6a6c22a90eda35 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-12-16T12:21:43Z |
| publishDate | 2021-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-d7fe2c76fdf646759d6a6c22a90eda352022-12-21T22:31:57ZengFrontiers Media S.A.Frontiers in Neurology1664-22952021-08-011210.3389/fneur.2021.620758620758Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS StudyTjalf Ziemssen0Frank Hoffmann1Stephan Richter2Ulrich Engelmann3Robin White4Department of Neurology, Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, GermanyKlinik für Neurologie, Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), GermanyZentrum für Neurologie und Psychiatrie, MIND, Stuttgart, GermanyMedical Affairs, Sanofi-Aventis Deutschland GmbH, Neu-Isenburg, GermanyMedical Affairs, Sanofi-Aventis Deutschland GmbH, Neu-Isenburg, GermanyThe non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing–remitting MS (TREAT-MS) study collects the so far largest real-life cohort regarding utilization, long-term effectiveness, and safety of alemtuzumab, a humanized monoclonal antibody directed against the cell surface glycoprotein CD52, in adult patients with active relapsing–remitting multiple sclerosis (RRMS). An interim analysis of baseline parameters at inclusion of a non-interventional real-world study about alemtuzumab in Germany including previous multiple sclerosis (MS) medication utilization, MS activity, severity, and duration, as well as comorbidities was performed. Of the 883 patients, 71.6% were women. Mean age was 35.7 ± 9.2 years, time since first MS symptoms (=disease duration) is 8.0 ± 6.8 years, and Expanded Disability Status Scale (EDSS) is 2.7 ± 1.8 points (range, 0.0–7.5 points). The number of relapses in the 12 and 24 months prior to inclusion were 1.6 ± 1.2 and 2.2 ± 1.8, respectively. Of the patients, 14.4% were treatment naive, while for the majority, a wide spectrum of MS disease-modifying treatments (DMTs) and treatment sequences were documented. Overall, interferon beta (IFN-beta) was reported most frequently (52.4%), followed by fingolimod (35.2%), natalizumab (34.9%), and glatiramer acetate (28.9%). Patients with longer disease duration and higher EDSS had a higher number of previous DMTs. Compared to the pivotal phase 2/3 studies, RRMS patients starting alemtuzumab treatment had a longer disease duration in real-world conditions. There was variety of different treatment sequences before the final switch to alemtuzumab. In the future, linking these treatment sequences or other baseline characteristics with effectiveness and safety outcomes might be useful to support treatment decisions. Registered at Paul-Ehrlich-Institut under NIS 281.https://www.frontiersin.org/articles/10.3389/fneur.2021.620758/fullalemtuzumabnon-interventional studyrisk-management planGermanyreal world datamultiple sclerosis |
| spellingShingle | Tjalf Ziemssen Frank Hoffmann Stephan Richter Ulrich Engelmann Robin White Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study Frontiers in Neurology alemtuzumab non-interventional study risk-management plan Germany real world data multiple sclerosis |
| title | Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study |
| title_full | Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study |
| title_fullStr | Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study |
| title_full_unstemmed | Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study |
| title_short | Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study |
| title_sort | alemtuzumab in a large real life cohort interim baseline data of the treat ms study |
| topic | alemtuzumab non-interventional study risk-management plan Germany real world data multiple sclerosis |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2021.620758/full |
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