Year: 2025
Type: article
Abstract: BACKGROUND AND OBJECTIVES: IV-administered ocrelizumab (OCR) is approved for the treatment of relapsing and primary progressive multiple sclerosis (RMS/PPMS). OCARINA II (NCT05232825) was designed to demonstrate noninferiority in drug exposure of OCR subcutaneous (SC) vs IV administration. METHODS: ); other end points included clinical, biomarker, and pharmacodynamic outcomes and safety data. RESULTS: (geometric mean ratios [90% CI] 1.29 [1.23-1.35] and 1.27 [1.21-1.34], respectively). At week 48, 111 of 118 (OCR IV/SC) and 114 of 118 (OCR SC/SC) had received OCR SC. A near-complete suppression of MRI activity was reported in OCR IV/SC and OCR SC/SC: 0 of 113 and 0 of 113 patients had T1 lesions while 1 of 114 and 1 of 113 had 2 and 1 new/enlarging T2 lesions, respectively. Two patients (1.9%) in each arm had 1 relapse, and 1 patient (0.9%; OCR SC/SC) had 2 relapses. In both arms, rapid and sustained B-cell depletion was observed and serum neurofilament light chain reduction was comparable. Patients receiving at least 1 dose of OCR SC 920 mg in the OCR IV/SC and OCR SC/SC arms reported adverse events (AEs): 75.4% and 86.4%, and serious AEs: 5.9% and 2.5%. The most frequently reported AEs were injection reactions (IRs, 51.5%); local and systemic IRs were experienced by 117 of 233 patients (50.2%) and 27 of 233 patients (11.6%), respectively. All IRs were mild/moderate; intensity and duration decreased with subsequent injections. DISCUSSION: The OCR SC formulation demonstrated noninferiority to OCR IV formulation regarding drug exposure, providing comparable efficacy and safety and an additional treatment option for patients with multiple sclerosis. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that a single SC injection of 920 mg of OCR achieves a noninferior 12-week area under serum concentration-time curve to that of 2 IV infusions of 300-mg OCR administered 2 weeks apart. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier NCT05232825; submitted: January 27, 2022; first patient enrolled: May 3, 2022; available at: clinicaltrials.gov/study/NCT05232825?term=NCT05232825&rank=1.
Source: Neurology
Authors: Scott D. Newsome, Ewa Krzystanek, Krzysztof W. Selmaj, Michal Dufek, Lawrence Goldstick, Carlo Pozzilli, Catarina Figueiredo, Ben Townsend, Heidemarie Kletzl, Oscar Bortolami, Dusanka Zecevic, Caroline Giacobino, Susanne Clinch, Yun-An Shen, Gurpreet Deol Bhullar, Hans-Martin Schneble, Diego Centonze
Institutions: Johns Hopkins University, Medical University of Silesia, University of Warmia and Mazury in Olsztyn, Masaryk University, St. Anne's University Hospital Brno, University of Cincinnati, Sapienza University of Rome, Roche (Switzerland), Roche (United Kingdom), Genentech, Roche (Canada), University of Rome Tor Vergata, Istituto Neurologico Mediterraneo
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4409531859