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Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study
BACKGROUND: To monitor long-term outcomes of ocrelizumab treatment. OBJECTIVE: To evaluate safety and treatment outcomes of ocrelizumab in a community-based multiple sclerosis (MS) population. METHODS: Adult patients with MS prescribed ocrelizumab were eligible. Chart reviews were conducted at the s...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264886/ https://www.ncbi.nlm.nih.gov/pubmed/34308352 http://dx.doi.org/10.1136/bmjno-2020-000108 |
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author | Smoot, Kyle Chen, Chiayi Stuchiner, Tamela Lucas, Lindsay Grote, Lois Cohan, Stanley |
author_facet | Smoot, Kyle Chen, Chiayi Stuchiner, Tamela Lucas, Lindsay Grote, Lois Cohan, Stanley |
author_sort | Smoot, Kyle |
collection | PubMed |
description | BACKGROUND: To monitor long-term outcomes of ocrelizumab treatment. OBJECTIVE: To evaluate safety and treatment outcomes of ocrelizumab in a community-based multiple sclerosis (MS) population. METHODS: Adult patients with MS prescribed ocrelizumab were eligible. Chart reviews were conducted at the start of ocrelizumab treatment and every 6 months thereafter. RESULTS: Of the 355 patients enrolled, 71.9% were female; mean (SD) age was 51.8 (12.5) years; 78.3% had relapsing MS (RMS). Median baseline Expanded Disability Status Scale (EDSS) (IQR) was 3.0 (2.0–4.0) for RMS, 6.5 (6.0–7.5) for secondary progressive MS, and 6.5 (6.0–7.0) for primary progressive MS. Respiratory infections occurred in 40.1% and urinary tract infections in 33.1% of patients. There was no difference in the percentage of infections among patients <55 (68.5%, n=122), and those ≥55 of age (67.5%, n=104) (p=0.94). Twenty-five hospitalisations were due to infections; 69.2% of these patients were ≥55 with a mean EDSS of 5.7 (±1.86). Four patients have died. Serum IgM and IgG levels did not predict infection risk. Annualised relapse rate was 0.34 for the patients with RMS in the preceding 2 years and 0.09 in patients who received ≥2 ocrelizumab 600 mg courses. The first on-treatment MRI was stable in 262 (90.0%) patients, 6.9% had new T2 lesions, 2.7% had enlarging T2 lesions and 1.4% had gadolinium-enhancing lesions. Median EDSS at 12 months was unchanged. CONCLUSION: Ocrelizumab effectively controlled relapse risk and disability worsening. Although only 12.1% of patients have discontinued ocrelizumab, infections resulting in hospitalisation are a concern, especially in older and disabled patients. |
format | Online Article Text |
id | pubmed-8264886 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-82648862021-07-23 Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study Smoot, Kyle Chen, Chiayi Stuchiner, Tamela Lucas, Lindsay Grote, Lois Cohan, Stanley BMJ Neurol Open Original Research BACKGROUND: To monitor long-term outcomes of ocrelizumab treatment. OBJECTIVE: To evaluate safety and treatment outcomes of ocrelizumab in a community-based multiple sclerosis (MS) population. METHODS: Adult patients with MS prescribed ocrelizumab were eligible. Chart reviews were conducted at the start of ocrelizumab treatment and every 6 months thereafter. RESULTS: Of the 355 patients enrolled, 71.9% were female; mean (SD) age was 51.8 (12.5) years; 78.3% had relapsing MS (RMS). Median baseline Expanded Disability Status Scale (EDSS) (IQR) was 3.0 (2.0–4.0) for RMS, 6.5 (6.0–7.5) for secondary progressive MS, and 6.5 (6.0–7.0) for primary progressive MS. Respiratory infections occurred in 40.1% and urinary tract infections in 33.1% of patients. There was no difference in the percentage of infections among patients <55 (68.5%, n=122), and those ≥55 of age (67.5%, n=104) (p=0.94). Twenty-five hospitalisations were due to infections; 69.2% of these patients were ≥55 with a mean EDSS of 5.7 (±1.86). Four patients have died. Serum IgM and IgG levels did not predict infection risk. Annualised relapse rate was 0.34 for the patients with RMS in the preceding 2 years and 0.09 in patients who received ≥2 ocrelizumab 600 mg courses. The first on-treatment MRI was stable in 262 (90.0%) patients, 6.9% had new T2 lesions, 2.7% had enlarging T2 lesions and 1.4% had gadolinium-enhancing lesions. Median EDSS at 12 months was unchanged. CONCLUSION: Ocrelizumab effectively controlled relapse risk and disability worsening. Although only 12.1% of patients have discontinued ocrelizumab, infections resulting in hospitalisation are a concern, especially in older and disabled patients. BMJ Publishing Group 2021-07-07 /pmc/articles/PMC8264886/ /pubmed/34308352 http://dx.doi.org/10.1136/bmjno-2020-000108 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Smoot, Kyle Chen, Chiayi Stuchiner, Tamela Lucas, Lindsay Grote, Lois Cohan, Stanley Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study |
title | Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study |
title_full | Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study |
title_fullStr | Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study |
title_full_unstemmed | Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study |
title_short | Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study |
title_sort | clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a us community ms center: an observational study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264886/ https://www.ncbi.nlm.nih.gov/pubmed/34308352 http://dx.doi.org/10.1136/bmjno-2020-000108 |
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