Novartis today announced new data from two studies evaluating Kesimpta® (ofatumumab) in adults with relapsing multiple sclerosis (RMS), to be presented at ECTRIMS 2025 in Barcelona, Spain.
ARTIOS Phase IIIb Study
- Design: Open-label, single-arm, prospective study of patients who switched to Kesimpta following breakthrough disease on fingolimod or fumarate-based therapies.
- Results:
- >90% of patients achieved NEDA-3 (no evidence of disease activity)
- Annualized relapse rate (ARR): 0.06 over 96 weeks
- MRI activity nearly completely suppressed
- No new safety concerns observed, regardless of prior therapy
Dr. Riley Bove, UCSF:
"These findings demonstrate robust, sustained disease control in patients who did not respond well to oral DMTs, supporting the efficacy and safety of Kesimpta following a treatment switch."
ALITHIOS Open-Label Extension Study
- Population: Recently diagnosed, treatment-naïve RMS patients (≤3 years) receiving first-line Kesimpta
- Results:
- >90% progression-free at seven years
- Sustained low ARR and profound MRI suppression
- Favorable long-term safety profile
Norman Putzki, MD, PhD, Novartis:
"The long-term data highlight Kesimpta’s ability to deliver sustained efficacy and consistent safety, reinforcing its role as a therapy that empowers patients to take early control of their disease."
About Kesimpta® (ofatumumab)
- Mechanism: Targeted anti-CD20 monoclonal antibody for selective B-cell depletion
- Administration: Monthly subcutaneous self-injection after initial doses at Weeks 0, 1, and 2 under healthcare supervision
- Approval: Approved in over 92 countries; more than 150,000 patients treated as of August 2025
About Multiple Sclerosis
MS is a chronic inflammatory disease of the central nervous system causing myelin and axonal damage, affecting nearly 3 million people worldwide. RMS is characterized by relapses and/or neurological progression, impacting the brain, optic nerves, and spinal cord.
Safety Profile
Kesimpta may cause serious side effects including:
- Infections (including HBV reactivation)
- Progressive multifocal leukoencephalopathy (PML)
- Injection-related reactions
- Low immunoglobulin levels and liver damage
Common side effects include upper respiratory tract infections and headache. Patients should consult healthcare providers before starting Kesimpta.
