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ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial.
- Source :
- Journal of Neurology; Jul2024, Vol. 271 Issue 7, p4348-4360, 13p
- Publication Year :
- 2024
-
Abstract
- Introduction: Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). The safety profile and patient preference for conventional versus shorter ocrelizumab infusions were investigated in the ENSEMBLE PLUS study. Methods: ENSEMBLE PLUS was a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810), comparing outcomes in patients with early-stage relapsing–remitting MS receiving ocrelizumab 600 mg over the approved 3.5-h (conventional) versus 2-h (shorter) infusion. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first randomized dose (RD); the secondary endpoint included IRR frequency at subsequent RDs. Results: At first RD, the number of patients with an IRR in the conventional (101/373; 27.1%) versus shorter (107/372; 28.8%) infusion group was similar (difference, stratified estimates [95% CI]: 1.9% [− 4.4, 8.2]). Most IRRs (conventional: 99.4%; shorter: 97.7%) were mild/moderate. IRR frequency decreased over the course of RDs; three patients discontinued from the shorter infusion arm but continued with conventional infusion. Overall, > 98% of IRRs resolved without sequelae in both groups. Pre-randomization throat irritation was predictive of future throat irritation as an IRR symptom. Adverse events (AEs) and serious AEs were consistent with the known ocrelizumab safety profile. On completion of ENSEMBLE PLUS, most patients chose to remain on (95%) or switch to (80%) shorter infusion. Conclusion: ENSEMBLE PLUS demonstrates the safety and tolerability of shorter ocrelizumab infusions. Most patients remained on/switched to shorter infusion after unblinding; IRRs did not strongly influence patient decisions. Clinical Trials Registration: Substudy of ENSEMBLE (NCT03085810). Registration: March 21, 2017. [ABSTRACT FROM AUTHOR]
- Subjects :
- RANDOMIZED controlled trials
CLINICAL trial registries
PATIENT preferences
Subjects
Details
- Language :
- English
- ISSN :
- 03405354
- Volume :
- 271
- Issue :
- 7
- Database :
- Complementary Index
- Journal :
- Journal of Neurology
- Publication Type :
- Academic Journal
- Accession number :
- 178340938
- Full Text :
- https://doi.org/10.1007/s00415-024-12326-z