Switching to SC Kesimpta from IV Anti-CD20 Therapies is Safe, Effective Across Diverse Individuals with Relapsing MS

Study results presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025 demonstrated that treatment with Kesimpta (ofatumumab; Novartis, Cambridge, MA) maintained efficacy across ethnic and racial groups in individuals with relapsing multiple sclerosis (RMS) transitioning from intravenous anti-CD20 therapies, such as rituximab or Ocrevus (ocrelizumab; Genentech, South San Francisco, CA). Kesimpta is an FDA-approved anti-CD20 therapy administered subcutaneously via autoinjector pen.

Post-hoc analysis of the OLIKOS study (NCT04486716) included 102 participants aged 18 to 60 years with RMS who had previously received ≥2 courses of Ocrevus or rituximab, were stable on their previous therapy, and switched treatment for reasons other than safety or lack of efficacy. Of these participants, 19.6% (n=20) identified as non-Hispanic Black (NHB), 29.4% (n=30) as Hispanic/Latino (Hispanic), 47.1% (n=48) as non-Hispanic White (NHW), and 3.9% (n=4) as other. Participants received Kesimpta 20 mg subcutaneously via autoinjector pen with standard loading and monthly maintenance doses for a 12-month period. The primary endpoint was the proportion of patients showing no change or a reduction in the number of gadolinium-enhancing T1 lesions observed on MRI from baseline to month 12. Secondary endpoints included immune biomarker changes and treatment-emergent adverse events (TEAEs).

Key findings from the study included the following:

• At 12 months, 100% of patients with evaluable MRI assessments met the primary endpoint across all race and ethnic subgroups, with no gadolinium-enhancing T1 lesions identified.
• Mean immunoglobulin G (IgG) and immunoglobulin M (IgM) levels remained within normal reference levels (IgG, 7-16 g/L; IgM, 0.4-2.3 g/L) across all subgroups from baseline to month 12.
• 84.3% (n=86) of participants experienced TEAEs during the study. The most common TEAEs across all subgroups were COVID-19 (30.4%), headache (13.7%), and fatigue (11.8%).
• New/enlarging T2 lesions were identified in 4.9% (n=5) of participants at month 6 (1 NHB, 3 Hispanic, 1 NHW) and 2.0% (n=2) of participants at month 12 (1 Hispanic, 1 NHW).