Novartis has announced positive long-term data from an open-label extension (OLE) study of its multiple sclerosis (MS) treatment, Kesimpta (ofatumumab).
Results from the ALITHIOS OLE showed sustained efficacy of first-line and continuous treatment with the anti-CD20 monoclonal antibody for up to six years in recently diagnosed, treatment-naïve (RDTN) patients with relapsing forms of the neurological disease.
According to the data presented at this year’s American Academy of Neurology Annual Meeting, RDTN relapsing MS patients experienced 44% fewer relapses and 24.5% and 21.6% fewer three- and six-month confirmed disability worsening events, respectively, compared to those who switched to Kesimpta from the disease-modifying therapy teriflunomide.
Patients in the RDTN cohort also demonstrated 96.4% and 82.7% reductions in Gd+ T1 and neT2 lesions, respectively.
“Our analysis of treatment-naïve people who were recently diagnosed with relapsing MS found that first-line use of Kesimpta for up to six years provided long-term benefits, including fewer relapses, profoundly suppressed MRI lesion activity, and fewer disability worsening events,” said principal investigator Gabriel Pardo, of the Oklahoma Medical Research Foundation.
Pardo added that, while measurable improvements were also seen in patients switching to Kesimpta later on, “the delay in irreversible disability worsening was not fully realised in the switch group compared to those starting on Kesimpta first, reinforcing the value of introducing the treatment to patients earlier”.
Affecting approximately 2.8 million people worldwide, MS is a neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.
Relapsing forms of MS are characterised by attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing MS, compared to 15% with progressive forms of the disease.
Novartis’ Kesimpta, which is self-administered by a once-monthly injection, works by destroying B cells – types of cells in the immune system – so that there are fewer left to damage the myelin covering. The therapy has already been approved to treat relapsing forms of MS in over 90 countries worldwide.