2023-04-20 06:31:38 ET
Novartis ( NYSE: NVS ) said early and continuous treatment with Kesimpta for up to five years in patients with relapsing multiple sclerosis (RMS) showed fewer disability worsening events and low brain volume change versus those who started on Sanofi's Aubagio (teriflunomide) and later switched to Kesimpta.
The Swiss pharma giant reported new long-term data from the ALITHIOS open-label extension study.
The company said earlier treatment with Kesimpta was linked with fewer confirmed disability worsening (CDW) events, including progression independent of relapse activity and relapse linked worsening, compared to those who switched later from teriflunomide. More than 80% of patients remained free of six-month CDW over the same 5 year period.
Brain volume change remained low (less than 1.5% loss) with Kesimpta over five years,
Novartis noted that annual rate of brain volume change (ABVC) in the core Phase 3 trials for continuous Kesimpta was -0.34%/year and in the switch group, -0.42%/year. In the extension, ABVC in the Kesimpta group was -0.27%/year and in the switch group -0.28%/year.
The company added that results related to both disability progression and brain volume change up to five years favored earlier start of Kesimpta in patients with RMS.
"These longer-term data continue to reinforce the favorable safety profile of Kesimpta, as well as its ability to slow disease progression, supporting its earlier use in people with relapsing multiple sclerosis," said Victor Bultó, president, Innovative Medicines US, Novartis Pharmaceuticals Corporation.
In addition, Novartis noted that a separate analysis showed that Kesimpta for up to five years was well-tolerated, with no new or increased safety risks seen.
The most common adverse events (AEs) were infections [COVID-19 (30.3%)], nasopharyngitis (19%), upper respiratory tract infection (12.8%) and urinary tract infection (12.7%).
The overall rate of serious infections remained stable with no increased risk over five years (106 patients, or 5.38%, experienced serious infection in the core Phase 3 plus extension trials).
The company added that average serum immunoglobulin G (IgG) levels remained stable up to five years of therapy and the majority of patients (98%) had lgG levels above the lower limit of normal (LLN).
Mean serum immunoglobulin M (IgM) levels declined over time but remained above the LLN for the majority of patients (69.4%), added Novartis.
There were six deaths due to serious infections. Five were COVID-19-related and one was due to pneumonia and septic shock, according to the company.
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Novartis Kesimpta shows benefit in multiple sclerosis patients in 5-year data