Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
| Autor: | Ann D Bass, Deidre Kile, Scott D. Newsome, Gabriel Pardo, B Musch, Robert A. Bermel, Pavle Repovic, Ashish Pradhan, J. W. Lindsey, Aram Zabeti, Emmanuelle Waubant |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Neurosciences. Biological psychiatry. Neuropsychiatry Brief Communication Antibodies Monoclonal Humanized 03 medical and health sciences 0302 clinical medicine Multiple Sclerosis Relapsing-Remitting Internal medicine Outcome Assessment Health Care Medicine Humans Immunologic Factors In patient RC346-429 business.industry Infusion time General Neuroscience Middle Aged Discontinuation Safety profile 030104 developmental biology Ocrelizumab Female Neurology. Diseases of the nervous system Neurology (clinical) business Brief Communications 030217 neurology & neurosurgery RC321-571 medicine.drug Follow-Up Studies |
| Zdroj: | Annals of Clinical and Translational Neurology Annals of Clinical and Translational Neurology, Vol 8, Iss 3, Pp 711-715 (2021) |
| ISSN: | 2328-9503 |
| Popis: | The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclerosis who had a suboptimal response to previous disease‐modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing four doses of OCR per initial US prescribing recommendations in the main study, participants in the substudy (N = 129) received a fifth dose over a 2‐h duration (vs. 3.5 h). Infusion‐related reactions occurred in 12.4% of patients. None were severe, life‐threatening or led to treatment discontinuation. Shorter infusion time did not change the safety profile of OCR. Clinicaltrials.gov (NCT0237856). |
| Databáze: | OpenAIRE |
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