Six-Year Efficacy of Novartis Kesimpta® in Newly Diagnosed Relapsing MS Patients

Novartis has unveiled findings from the ALITHIOS open-label extension study, spotlighting the enduring effectiveness of continuous Kesimpta® (ofatumumab) treatment for up to six years in individuals recently diagnosed with relapsing multiple sclerosis (RMS). This group, characterized by commencing treatment within three years of diagnosis, experienced notable benefits, including a 44% reduction in relapses, a substantial decrease of 96.4% and 82.7% in MRI lesions (Gd+ T1 and neT2, respectively), and a reduction of 24.5% and 21.6% in 3- and 6-month confirmed disability worsening (CDW) events, respectively, compared to those transitioning from teriflunomide to Kesimpta.

Principal investigator Gabriel Pardo, M.D., from the Multiple Sclerosis Center of Excellence at Oklahoma Medical Research Foundation, emphasized the prolonged advantages observed in those who initiated Kesimpta early, citing fewer relapses, suppressed MRI lesion activity, and diminished disability worsening events. Although improvements were evident in patients switching to Kesimpta later, the delay in irreversible disability worsening was not as pronounced compared to those initiating Kesimpta first, underscoring the importance of early treatment introduction.

Norman Putzki, M.D., Development Unit Head at Novartis Pharmaceuticals Corporation, expressed satisfaction with the ALITHIOS data, emphasizing Kesimpta’s growing reputation as an effective and well-tolerated RMS therapy. Novartis remains committed to addressing the significant challenges faced by MS patients through ongoing research and the development of transformative treatments aimed at achieving comprehensive disease control.

Key study results indicate a remarkable reduction in annualized relapse rates (ARR) among treatment-naïve individuals receiving continuous Kesimpta, with rates of progression independent of relapse activity (PIRA) also demonstrating a decline compared to switch therapy. The proportion of participants achieving no evidence of disease activity (NEDA-3) with continuous Kesimpta remained consistently high over the six-year period.

Moreover, individuals initially treated with teriflunomide and later switched to Kesimpta experienced significant improvements in various efficacy measures, including ARR and MRI lesion activity reductions, and accelerated attainment of NEDA-3 status. However, rates of disability worsening events remained higher compared to those continuously treated with Kesimpta, indicating the enduring efficacy benefit of early Kesimpta initiation.

The study affirms the sustained efficacy and tolerability of continuous Kesimpta treatment over six years, with no unexpected safety concerns identified. Adverse event rates remained stable, with infections being the most common, and no meaningful association observed between immunoglobulin levels and serious infections.

Multiple sclerosis (MS) is described as a chronic inflammatory disorder affecting the central nervous system, characterized by myelin destruction and axonal damage. Kesimpta® (ofatumumab) stands as a targeted B-cell therapy offering self-administration for individuals with relapsing forms of MS. Its safety profile and efficacy have been demonstrated in both core studies and the ALITHIOS extension study, with over 100,000 patients treated globally as of March 2024.

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