Trial reportNeurology(R) neuroimmunology & neuroinflammation2020
Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS.
Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03085810 (An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial.Journal of neurology · 2024Trial
- Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial.Annals of clinical and translational neurology · 2021Trial
- Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.Multiple sclerosis and related disorders · 2020Trial
- Navigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities.Clinical and translational science · 2025Review
- B cell targeted therapies in inflammatory autoimmune disease of the central nervous system.Frontiers in immunology · 2023Review
- Product review on MAbs (alemtuzumab and ocrelizumab) for the treatment of multiple sclerosis.Human vaccines & immunotherapeutics · 2021Article
- Fast and safe: Optimising multiple sclerosis infusions during COVID-19 pandemic.Multiple sclerosis and related disorders · 2021Article
- Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?Frontiers in immunology · 2021Review
- Ocrelizumab for the Treatment of Multiple Sclerosis: Safety, Efficacy, and Pharmacology.Therapeutics and clinical risk management · 2021Review
- Reinitiating ocrelizumab with a full 600 mg dose after extended treatment interruption: No increased risk of infusion-related reactions.Multiple sclerosis journal - experimental, translational and clinicalArticle
- Tolerability and Safety of Switching from Rituximab to Ocrelizumab: Evaluating Factors Associated with Infusion Related Reactions.Multiple sclerosis journal - experimental, translational and clinicalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo assess the safety of ocrelizumab (OCR) shorter duration infusion in patients with MS.
methodsENSEMBLE 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).
resultsFrom 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.
conclusionThe 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.
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