Novartis Presents New Long-Term Data on Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis

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.

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