About: Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS

Facets (new session)
Description
Metadata
Settings
- owl:sameAs
- Inference Rule:

About: Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS
Creator	Hartung, Hans-Peter Org/Coe, Npub
Source	PMC
abstract	OBJECTIVE: To assess the safety of ocrelizumab (OCR) shorter duration infusion in patients with MS. METHODS: ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early stage relapsing-remitting MS received OCR 600 mg initially as two 300 mg IV infusions 2 weeks apart and subsequently as a single 3.5-hour 600 mg infusion every 24 weeks for 192 weeks. In ENSEMBLE PLUS, OCR 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration). The primary end point was the proportion of patients with infusion-related reactions (IRRs) after the first randomized dose (assessed during and up to 24 hours postinfusion). RESULTS: From November 1, 2018, to September 27, 2019, 580 patients were randomized 1:1 to the conventional or shorter infusion group. After the first randomized dose, 67 of 291 patients (23.1%) in the conventional and 71 of 289 patients (24.6%) in the shorter infusion group experienced IRRs. Most IRRs were mild or moderate in both groups; one patient in each group experienced a severe IRR, and in both groups, 98.6% (136 of 138) of all IRRs resolved without sequelae. No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuation occurred. During the first randomized dose, 14 of 291 (4.8%) and 25 of 289 (8.7%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. CONCLUSION: The frequency and severity of IRRs were similar between conventional and shorter OCR infusions. Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. CLASSIFICATION OF EVIDENCE: This interventional study provides Class I evidence that the frequency and severity of IRRs were similar at the first randomized dose using OCR (600 mg) infusions of conventional and shorter duration in patients with relapsing-remitting MS. CLINICAL TRIAL IDENTIFIER NUMBER: NCT03085810.
has issue date	2020-06-04(xsd:dateTime)
bibo:doi	10.1212/nxi.0000000000000807
bibo:pmid	32503093
has license	cc-by-nc-nd
sha1sum (hex)	5af4f9f25a2b24b5a7d20dd3120e597b250806e7
schema:url	https://doi.org/10.1212/nxi.0000000000000807
resource representing a document's title	Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS
has PubMed Central identifier	PMC7286651
has PubMed identifier	32503093
schema:publication	Neurol Neuroimmunol Neuroinflamm
resource representing a document's body	covid:5af4f9f25a2b24b5a7d20dd3120e597b250806e7#body_text
is schema:about of	covid:arg/5af4f9f25a2b24b5a7d20dd3120e597b250806e7 named entity 'therapeutic' named entity 'Ocrelizumab' named entity 'OCR' named entity 'Australia' named entity 'primary research' named entity 'Cmax' named entity 'OCR' named entity 'follow-up' named entity 'monoclonal antibody' named entity 'unblinding' named entity 'RRMS' named entity 'Roche' named entity 'institutional review boards' named entity 'relapsing-remitting MS' named entity 'symptom' named entity 'OCR' named entity 'OCR' named entity 'intent-to-treat' named entity 'paracetamol' named entity 'intraductal papilloma' named entity '3.5' named entity 'symptom' named entity 'AEs' named entity 'sodium chloride' named entity 'adverse events' named entity 'Cmax' named entity 'Ocrelizumab' named entity 'OCR' named entity 'ocrelizumab' named entity 'randomized, double-blind' named entity 'RRMS' named entity 'AEs' named entity 'headache' named entity 'typhoid fever' named entity 'anti-CD20' named entity 'weighted average' named entity 'unblinded' named entity 'end point' named entity 'depressive symptoms' named entity 'OCR' named entity 'chlorpheniramine' named entity 'RRMS' named entity 'OCR' named entity 'block size' named entity 'serum' named entity 'intent-to-treat' named entity 'primary progressive' named entity 'OCR' named entity 'OCR' named entity 'OCR' named entity 'intent-to-treat' named entity 'Clinical Study' named entity 'data monitoring committee' named entity 'safety profile' named entity 'throat irritation' named entity 'RRMS' named entity 'ITT' named entity 'urinary tract infection' named entity 'OCR' named entity 'OCR' named entity 'OCR' named entity 'Roche' named entity 'Expanded Disability Status Scale' named entity 'hypotension' named entity 'peak concentration' named entity 'peripheral edema' named entity '3.5' named entity 'OCR' named entity '3.5' named entity 'AEs' named entity 'adverse event' named entity 'depression' named entity 'AEs' named entity 'symptomatic treatment' named entity 'ocrelizumab' named entity 'Canada' named entity 'OCR' named entity 'informed consent' named entity 'OCR'

Faceted Search & Find service v1.13.91 as of Mar 24 2020

Alternative Linked Data Documents: Sponger | ODE Content Formats:

RDF

ODATA

Microdata

About

OpenLink Virtuoso version 07.20.3229 as of Jul 10 2020, on Linux (x86_64-pc-linux-gnu), Single-Server Edition (94 GB total memory)
Data on this page belongs to its respective rights holders.
Virtuoso Faceted Browser Copyright © 2009-2024 OpenLink Software