2024 American Academy of Neurology Abstract Website

Enrique Alvarez¹, Brandon Brown², Elizabeth Camacho², Benjamin Greenberg³, Roland Henry⁴, Rebecca Piccolo², Le Hua⁵
¹The Rocky Mountain MS Center at the University of Colorado, Anschutz Medical Campus, ²Novartis Pharmaceuticals Corporation, ³Department of Neurology, University of Texas Southwestern Medical Center, Neurology, ⁴UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, ⁵Cleveland Clinic Lou Ruvo Center for Brain Health

Objective:

Describe 6-month interim efficacy and safety results for patients enrolled in OLIKOS.

Background:

Anti-CD20 therapies are effective treatments for relapsing multiple sclerosis (RMS). Unlike intravenously (IV) administered ocrelizumab and rituximab, ofatumumab is administered subcutaneously (SC) via autoinjector pen.

Design/Methods:

OLIKOS (single-arm, open-label, phase 3b study [NCT04486716]) enrolled patients (aged 18-60 years) with RMS who received ≥2 courses of IV anti-CD20 therapy (ocrelizumab or rituximab). Patients were required to be stable on their previous therapy and switched for reasons other than safety or lack of efficacy. Eligible patients received ofatumumab 20 mg SC via autoinjector over 12 months. The primary endpoint was the proportion of patients with no change or reduction in the number of gadolinium-enhancing (Gd+) lesions from baseline to Month 12. Safety endpoints included treatment-emergent adverse events (TEAEs). Exploratory endpoints included changes in hematology parameters.

Results:

OLIKOS enrolled 111 patients; 102 received ofatumumab and were included in the analysis. The mean (SD) age at baseline was 44 (8.2) years, and most patients were White (76.5%), female (67.6%), and previously received ocrelizumab before switching (99.0%). Median (range) baseline Expanded Disability Status Scale score and mean (SD) disease duration were 2.9 (0.0-5.5) and 9.4 (7.1) years, respectively. At baseline, mean (SD) number of Gd+ T1 lesions (n=101) was 0.01 (0.1), and immunoglobulin G (IgG) and IgM levels (g/L) were 9.9 (2.8) and 0.6 (0.4), respectively. At 6 months, all patients with available Gd+ T1 lesion data (n=77) met the primary endpoint (95% CI: 0.95-1.00). TEAEs occurred at the same frequency as in the phase 3 clinical trials. Six-month mean (SD) IgG and IgM levels (g/L; n=95) were 9.8 (2.9) and 0.5 (0.3), respectively.

Conclusions:

Ofatumumab 20 mg SC maintained efficacy at 6 months in patients with RMS transitioning from IV anti-CD20 therapies, as demonstrated by no Gd+ T1 lesions. No new safety signals were identified.