PMID- 35614917
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1664-2295 (Print)
IS  - 1664-2295 (Electronic)
IS  - 1664-2295 (Linking)
VI  - 13
DP  - 2022
TI  - Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients 
      Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study.
PG  - 863105
LID - 10.3389/fneur.2022.863105 [doi]
LID - 863105
AB  - 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.
CI  - Copyright (c) 2022 Weber, Buttmann, Meuth, Dirks, Muros-Le Rouzic, Eggebrecht, 
      Hieke-Schulz, Leemhuis and Ziemssen.
FAU - Weber, Martin S
AU  - Weber MS
AD  - Department of Neurology, Institute of Neuropathology, University Medicine 
      Gottingen, Gottingen, Germany.
AD  - Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Gottingen, 
      Germany.
FAU - Buttmann, Mathias
AU  - Buttmann M
AD  - Caritas-Hospital, Bad Mergentheim, Germany.
FAU - Meuth, Sven G
AU  - Meuth SG
AD  - Clinic of Neurology, Heinrich-Heine University, Dusseldorf, Germany.
FAU - Dirks, Petra
AU  - Dirks P
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Muros-Le Rouzic, Erwan
AU  - Muros-Le Rouzic E
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Eggebrecht, Julius C
AU  - Eggebrecht JC
AD  - Roche Pharma AG, Grenzach-Wyhlen, Germany.
FAU - Hieke-Schulz, Stefanie
AU  - Hieke-Schulz S
AD  - Roche Pharma AG, Grenzach-Wyhlen, Germany.
FAU - Leemhuis, Jost
AU  - Leemhuis J
AD  - Roche Pharma AG, Grenzach-Wyhlen, Germany.
FAU - Ziemssen, Tjalf
AU  - Ziemssen T
AD  - Center of Clinical Neuroscience, Neurological Clinic, Carl Gustav Carus 
      University Clinic, University of Technology, Dresden, Germany.
LA  - eng
PT  - Journal Article
DEP - 20220509
PL  - Switzerland
TA  - Front Neurol
JT  - Frontiers in neurology
JID - 101546899
PMC - PMC9126090
OTO - NOTNLM
OT  - drug (or treatment) persistence
OT  - humanized monoclonal antibody anti-CD20
OT  - multiple sclerosis
OT  - neurodegenerative diseases
OT  - non-interventional study (NIS)
OT  - ocrelizumab
OT  - real-world cohort
OT  - safety
COIS- 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 Universitatsmedizin Gottingen. 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 fur Risikobewertung (BfR), Deutsche Forschungsgemeinschaft (DFG), 
      Else Kroner 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.
EDAT- 2022/05/27 06:00
MHDA- 2022/05/27 06:01
PMCR- 2022/05/09
CRDT- 2022/05/26 02:13
PHST- 2022/01/26 00:00 [received]
PHST- 2022/03/30 00:00 [accepted]
PHST- 2022/05/26 02:13 [entrez]
PHST- 2022/05/27 06:00 [pubmed]
PHST- 2022/05/27 06:01 [medline]
PHST- 2022/05/09 00:00 [pmc-release]
AID - 10.3389/fneur.2022.863105 [doi]
PST - epublish
SO  - Front Neurol. 2022 May 9;13:863105. doi: 10.3389/fneur.2022.863105. eCollection 
      2022.