Novartis has presented new data from two clinical trials that further support the use of Kesimpta (ofatumumab) in the treatment of relapsing multiple sclerosis (RMS).
Kesimpta, a self-administered, once-monthly subcutaneous injection, is an anti-CD20 monoclonal antibody (mAb) that targets B cells. The therapy was originally developed by Genmab and licensed to GlaxoSmithKline before Novartis acquired the rights in December 2015. It is currently approved for RMS in 92 countries.
The latest findings reported by Novartis reinforce Kesimpta’s efficacy in reducing annualised relapse rate (ARR). The ARTIOS trial evaluated the therapy in patients switching from oral disease-modifying treatments, while the ALITHIOS trial assessed its long-term use as a first-line therapy in treatment-naïve patients.
Results from the phase 3b ARTIOS study – an open-label, single-arm, prospective trial – showed that patients who switched to Kesimpta following one or more relapses or signs of MRI activity while on fingolimod or fumarate-based therapies, experienced a lower ARR. MRI activity was suppressed and more than 90% of participants achieved no evidence of disease activity (NEDA-3) during the study period.
The separate open-label extension ALITHIOS study evaluated Kesimpta in recently diagnosed, treatment-naïve patients. After seven years, more than 90% of participants achieved NEDA-3, supported by sustained low relapse rates and suppressed MRI activity. The safety profile remained favourable, both in this subgroup and across the broader patient population.
“The long-term data from these studies underscores Kesimpta’s ability to deliver sustained efficacy and a consistent safety profile for people with RMS,” said Norman Putzki, global head of development, neuroscience and gene therapy at Novartis. “These findings reinforce Kesimpta’s position as a therapy that empowers patients to take early control of their disease.”