Real-world experience of ocrelizumab initiation in a diverse multiple sclerosis population
•We report real-world experience of OCR initiation in a diverse MS population.•This is the first study reporting safety and efficacy of OCR in different racial/ethnic patient populations.•We report two cases of severe babesia microti infection while patients were on OCR.•We report that OCR is overal...
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Veröffentlicht in: | Multiple sclerosis and related disorders 2021-08, Vol.53, p.103021-103021, Article 103021 |
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Zusammenfassung: | •We report real-world experience of OCR initiation in a diverse MS population.•This is the first study reporting safety and efficacy of OCR in different racial/ethnic patient populations.•We report two cases of severe babesia microti infection while patients were on OCR.•We report that OCR is overall well tolerated and effective in our diverse patient population.
Ocrelizumab (OCR) is a humanized monoclonal antibody directed against CD20 positive B-lymphocytes. It was approved for use in 2017 by the U.S. Food and Drug Administration (FDA) for both the relapsing-remitting and primary progressive forms of multiple sclerosis (MS).
To provide real-world data for patients with MS treated with OCR in our center and evaluate both the safety and efficacy across different ethnic groups not studied in previous clinical trials.
We performed a retrospective observational analysis of MS patients who were treated with OCR from March 31, 2017 to April 30, 2020. We collected data on patients who had received at least a one dose infusion of OCR at our MS center. Patient characteristics, including demographics, clinical disease course, and documented side effects, were collected and analyzed.
A total of 82 patients were eligible for this study, of which 72% had relapsing-remitting MS (RRMS), 14% had primary progressive MS (PPMS), and 11% active/relapsing secondary progressive MS (SPMS). 22% of our patients were of African American descent, 61% Caucasian, and 17% of Hispanic descent. The mean age of starting OCR was 41 ± 11 years. 47% were treatment naïve when started on OCR, 24% were previously treated with one disease-modifying therapy (DMT), 14% were treated with two DMTs, and 15% were treated with more than two DMTs prior to OCR. 50% of patients had at least one adverse event while on OCR; 4.8% had adverse events requiring to OCR discontinuation, 36% had infusion-related reactions, and 7.3% had viral infections. We found two cases of severe babesiosis along with index cases of re-activation of lichen planus, agranulocytosis, severe lymphopenia, and ectopic pregnancy. There were no cases of malignancy, progressive multifocal leukoencephalopathy, or death within our cohort. The mean time after OCR initiation was 17.3 months in the RRMS group, 22.2 months in the PPMS group, and 28.2 months in SPMS group. The annualized relapse rate reduced from 1.33 to 0.15 in the RRMS group. The mean extended disability status scale (EDSS) scores did not worsen across MS phenotypes and ethn |
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ISSN: | 2211-0348 2211-0356 |
DOI: | 10.1016/j.msard.2021.103021 |