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. 2022 May 9:13:863105.
doi: 10.3389/fneur.2022.863105. eCollection 2022.

Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study

Martin S Weber  1   2 , Mathias Buttmann  3 , Sven G Meuth  4 , Petra Dirks  5 , Erwan Muros-Le Rouzic  5 , Julius C Eggebrecht  6 , Stefanie Hieke-Schulz  6 , Jost Leemhuis  6 , Tjalf Ziemssen  7
Affiliations

Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study

Martin S Weber et al. Front Neurol. .

Abstract

Background: Real-world relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) populations may be more diverse than in clinical trials. Here, we present a first analysis of safety, adherence and persistence data from a real-world cohort of patients newly treated with ocrelizumab.

Methods: CONFIDENCE (ML39632, EUPAS22951) is an ongoing multicenter, non-interventional post authorization safety study assessing patients with RMS or PPMS newly treated with ocrelizumab or other disease-modifying therapies for up to 10 years. For this analysis, patients newly treated with ocrelizumab were analyzed in subgroups by MS phenotype and age over a mean ~1 year of exposure totaling 2,329 patient years [PY]).

Results: At data cutoff (14 October 2020), 1,702 patients with RMS and 398 patients with PPMS were treated with ≥1 dose of ocrelizumab. At baseline, the mean ages (SD) of patients with RMS and PPMS were 41.59 (11.24) and 50.95 (9.88) years and the mean EDSS (Expanded Disability Status Scale) was 3.18 (1.87) and 4.41 (1.59), respectively. The most common adverse events (AEs) and serious AEs across both phenotypes were infections and infestations, with infection SAE rates of 2.8 events/100 PY and 1.5 events/100 PY in patients with RMS and PPMS, respectively. Across all phenotypes, ocrelizumab persistence was 92% at 24 months; median time between doses was ~6 months.

Conclusions: The ocrelizumab safety profile observed in the CONFIDENCE real-world MS population was consistent to the one observed in pivotal clinical trials. High treatment persistence and adherence were observed.

Trial registration: ML39632, EUPAS22951.

Keywords: drug (or treatment) persistence; humanized monoclonal antibody anti-CD20; multiple sclerosis; neurodegenerative diseases; non-interventional study (NIS); ocrelizumab; real-world cohort; safety.

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Conflict of interest statement

MW receives research support from the Deutsche Forschungsgemeinschaft (DFG; WE 3547/5-1), from Novartis, TEVA, Biogen-Idec, Roche, Merck and the ProFutura Programm of the Universitätsmedizin Göttingen. MW is serving as an editor for PLoS ONE, received travel funding and/or speaker honoraria from Biogen-Idec, Merck Serono, Novartis, Roche, TEVA, Bayer and Genzyme. MB received honoraria for lecturing, consulting and/or travel expenses for attending meetings from Bayer, Biogen, Boehringer, Bristol Myers Squibb, Coloplast, Daiichi-Sankyo, Das Fortbildungskolleg, Medscape, Merck, Novartis, Roche, Sandoz, Sanofi, and Teva. SM received honoraria for lecturing and travel expenses for attending meetings from Almirall, Amicus Therapeutics Germany, Bayer Health Care, Biogen, Celgene, Diamed, Genzyme, MedDay Pharmaceuticals, Merck Serono, Novartis, Novo Nordisk, ONO Pharma, Roche, Sanofi-Aventis, Chugai Pharma, QuintilesIMS, and Teva, research is funded by the German Ministry for Education and Research (BMBF), Bundesinstitut für Risikobewertung (BfR), Deutsche Forschungsgemeinschaft (DFG), Else Kröner Fresenius Foundation, Gemeinsamer Bundesausschuss (G-BA), German Academic Exchange Service, Hertie Foundation, Interdisciplinary Center for Clinical Studies (IZKF) Muenster, German Foundation Neurology and Alexion, Almirall, Amicus Therapeutics Germany, Biogen, Diamed, Fresenius Medical Care, Genzyme, HERZ Burgdorf, Merck Serono, Novartis, ONO Pharma, Roche and Teva. PD is an employee of F. Hoffmann-La Roche AG and shareholder of F. Hoffmann-La Roche AG. JE is an employee of Roche Pharma AG and shareholder of F. Hoffmann-La Roche AG. SH-S is an employee of Roche Pharma AG. JL is an employee of Roche Pharma AG and shareholder of F. Hoffmann-La Roche AG. EM-LR is an employee of F. Hoffmann-La Roche AG and shareholder of F. Hoffmann-La Roche AG. TZ reports grants and personal fees from Biogen, Roche, TEVA and grants, personal fees from Almirall, Biogen, Celgene, Biogen, Novartis, Merck, TEVA, Janssen, Roche. The authors declare that this study received funding from Roche. The funder had the following involvement in the study: study design, analysis, interpretation of data, the writing of this article and the decision to submit it for publication.

Figures

Figure 1
Figure 1
Kaplan-Meier estimates of persistence over 24-months of treatment with ocrelizumab (full analysis set). (A) RMS total + >55 years; (B) PPMS total + >55 years.
See this image and copyright information in PMC

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