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

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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 : wasabi.inria.fr associated with source document(s)

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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
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