We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Shorter Infusion Time of Ocrelizumab: Primary Results from the ENSEMBLE PLUS Study in Patients with Relapsing-Remitting Multiple Sclerosis.
- Authors
Perrin Ross, Amy; Berger, Thomas; Bermel, Robert; Freedman, Mark S.; Holmøy, Trygve; Killestein, Joep; Buffels, Regine; Garas, Monika; Kadner, Karen; Manfrini, Marianna; McNamara, John; Hartung, Hans-Peter
- Abstract
Background: Ocrelizumab is an intravenously administered anti-CD20 antibody approved for relapsing and primary progressive multiple sclerosis (MS). Shortening the infusion to 2 hours may reduce the total site stay from 5.5-6 hours (approved infusion duration including mandatory premedication/observation) to 4 hours, which may reduce patient and site staff burden. Objectives: To investigate the safety profile of ocrelizumab when administered over a shorter infusion period, using primary results from ENSEMBLE PLUS. Methods: ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (trial registration: NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS (18-55 years; treatment-naive; disease duration ≤3 years; Expanded Disability Status Scale score 0-3.5) receive ocrelizumab 600-mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab (600 mg) administered over the approved infusion time (3.5 hours; conventional duration), is compared with a 2-hour infusion (shorter duration); the initial infusion (2 x 300 mg) duration remains unaffected. The ENSEMBLE PLUS primary end point is the proportion of patients with infusion-related reactions (IRRs) following the first randomized infusion (frequency/severity assessed during and 24 hours postinfusion). Results: As of September 2019, 291 and 289 patients were randomized to the conventional and shorter infusion groups, respectively. Following the first randomized infusion, 67 patients (23.1%) in the conventional and 71 patients (24.6%) in the shorter infusion group had IRRs, from which 17.9% vs 31.0% were throat irritation and 25.4% vs 23.9% were fatigue, respectively. Most IRRs were mild or moderate; >98% of all IRRs resolved without sequelae in both groups. No IRRs were life threatening, serious, or fatal; 1 severe IRR occurred in both the conventional (laryngeal inflammation [second randomized dose]) and shorter duration groups (fatigue [first randomized dose]). No IRR-related discontinuations occurred. During the first randomized dose, 14 (4.8%) and 25 (8.7%) patients in the conventional and shorter infusion groups had IRRs leading to infusion interruption/slowing, respectively. Conclusions: Primary analysis suggests that the frequency/severity of IRRs are comparable between conventional and shorter infusions. No new safety signals were detected.
- Subjects
CONFERENCES &; conventions; INTRAVENOUS therapy; MONOCLONAL antibodies; MULTIPLE sclerosis; PATIENT safety; TIME
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p84
- ISSN
1537-2073
- Publication type
Article