Kesimpta Shows Sustained Long-Term Efficacy and Safety in Relapsing Multiple Sclerosis

New data from 2 long-term studies investigating Kesimpta (ofatumumab; Novartis, East Hanover, NJ) treatment were presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Together, the findings highlight the benefits of switching to the therapy after suboptimal response to oral disease-modifying treatments and the durability of disease control when used first line. Across both studies, Kesimpta demonstrated high rates of no evidence of disease activity (NEDA-3), sustained suppression of MRI activity, and low annualized relapse rates (ARR).

The phase 3b ARTIOS study (NCT02792218) was an open-label, single-arm, prospective trial that included 562 people with relapsing multiple sclerosis (RMS) who had breakthrough disease on Gilenya (fingolimod; Novartis, East Hanover, NJ) or fumarate-based therapies. Participants received monthly subcutaneous Kesimpta for up to 96 weeks, with disease activity and safety closely monitored.

ARTIOS results:

• The adjusted ARR was 0.06 at 96 weeks (95% CI, 0.05 to 0.08) and decreased to 0.02 by year 2.
• At week 96, 90.9% of participants had achieved NEDA-3.
• There was a 98.1% reduction in gadolinium-enhancing T1 lesions from baseline to week.
• Serum IgG levels remained stable in 97.9% of participants during the duration of the study.
• IgM levels decreased but remained above the lower limit of normal for 77.0% of participants.
• Safety profile consistent with prior studies, with mostly mild/moderate adverse events

The ALITHIOS (NCT03650114) open-label extension study examined long-term outcomes in treatment-naïve RMS patients diagnosed within the 3 years. Participants were initially randomized to Kesimpta or Aubagio (teriflunomide; Sanofi, Bridgewater, NJ) in ASCLEPIOS phase 2 (NCT02792218) and 3 (NCT02792231) and received 7 years of follow-up.

ALITHIOS results:

• The ARR reduced to from 0.095 to 0.043 in the continuous Kesimpta group and from 0.207 to 0.057 in those who switched from teriflunomide.
• Suppression of gadolinium-enhancing T1 lesion activity was sustained over 7 years.
• Over 90% of participants remained NEDA-3 at year 7.
• Serious adverse event rates, including infections and malignancies, remained stable across follow-up.
• IgG levels stable; IgM decreased but generally remained above the lower limit of normal.