New five-year data on disability outcomes and safety of Kesimpta in people living with relapsing multiple sclerosis

A separate analysis showed that treatment with Kesimpta for up to five years was well-tolerated, with no new or increased safety risks identified. These data will be presented at the American Academy of Neurology (AAN) Annual Meeting held in Boston and virtually on April 22-27, 2023.

“With continuous Kesimpta treatment, key indicators of disability progression and brain volume change showed that most patients remained free from disease progression up to five years,” said principal investigator Jeffrey A. Cohen, MD, of the Neurological Institute at Cleveland Clinic. “Outcomes favored earlier, compared with later, initiation of treatment with Kesimpta. Along with the five-year safety analysis, these data support this treatment as a well-tolerated, efficacious treatment option for people living with relapsing multiple sclerosis.”

In people with RMS who continued in the ALITHIOS study for up to five years, earlier treatment with Kesimpta was associated with fewer confirmed disability worsening (CDW) events, including progression independent of relapse activity and relapse associated worsening, versus those who switched later from teriflunomide. More than 80% of patients remained free of six-month CDW over the same five period.

Additionally, brain volume change remained low (less than 1.5% loss) with Kesimpta treatment over five years, and overall, patients initially randomized to Kesimpta had lower levels of brain volume loss at year five than those initially randomized to teriflunomide. Annual rate of brain volume change (ABVC) in the core Phase III trials for continuous Kesimpta was -0.34%/year and in the switch group, -0.42%/year (P=0.115). In the extension, ABVC in the Kesimpta group was -0.27%/year and in the switch group, -0.28%/year (P=0.666).

“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. “Novartis remains committed to the multiple sclerosis community in our continued study of Kesimpta and to supporting those living with MS and their families throughout their journey.”

The separate analysis of the ALITHIOS extension data showed consistent safety results of Kesimpta for people with RMS following up to five years of treatment. The overall rates of adverse events (AEs) and serious AEs were consistent with the core Phase III trials. The most common AEs were infections (COVID-19 [30.3%], nasopharyngitis [19%], upper respiratory tract infection [12.8%] and urinary tract infection [12.7%]). Most COVID-19 cases were mild to moderate in severity (93.9%) and non-serious (92.3%), and 98.6% of patients treated with Kesimpta recovered, recovered with sequalae, or were recovering from COVID-192. Most (90.3%) infections resolved without discontinuing Kesimpta treatment.

The overall rate of serious infections also remained stable with no increased risk over five years (106 patients, or 5.38%, experienced serious infection in the core Phase III plus extension trials). Mean serum immunoglobulin G (IgG) levels remained stable up to five years of treatment and the majority of patients (98%) had lgG levels above the lower limit of normal (LLN). Mean serum immunoglobulin M (IgM) levels decreased over time but remained above the LLN for the majority of patients (69.4%). There was no association between reduction in Ig levels and risk of serious infections. Treatment interruption/discontinuation was reported in three (0.2%)/four (0.2%) patients due to low lgG; and 202 (10.3%)/71 (3.6%) patients due to low lgM. There were six fatal cases due to serious infections (five were COVID-19-related and one was due to pneumonia and septic shock).