Early initiation of Kesimpta associated with lower rates of disability worsening in MS
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Key takeaways:
- 80% of study participants remained free of disability-worsening events at 6 months.
- Cumulative event rates for 6-month confirmed disability worsening with Kesimpta sustained up to 6 years.
Early initiation and continuation of Kesimpta in those with relapsing MS was associated with lower rates of disability worsening up to 6 years compared with those who switched medication, according to a presentation at ECTRIMS 2024.
“It is important to continue researching how high-efficacy treatments for relapsing multiple sclerosis affect people who are recently diagnosed and haven’t been on previous therapies,” Amit Bar-Or, MD, director of the Center for Neuroinflammation and Neurotherapeutics at the University of Pennsylvania, told Healio in an email. “[Progression independent of relapse activity] plays a substantial role in disease worsening and becomes the main contributor to disability progression as the disease evolves.”
Bar-Or and colleagues sought to examine efficacy up to 6 years of early initiation of continuous Kesimpta (ofatumumab, Novartis) treatment on disability outcomes compared with delayed treatment initiation following a switch from teriflunomide in those with relapsing MS.
Their study evaluated data from 1,367 individuals enrolled in the ASCLEPIOS I/II clinical trials who continued ofatumumab treatment in the ALITHIOS open-label study (continuous group, n = 690), as well as for individuals initially randomized to teriflunomide later switched to ofatumumab within ALITHIOS (switch group, n = 677).
The researchers analyzed event rates of 3- and 6-month confirmed disability worsening (CDW), 3- and 6-month progression independent of relapse activity (PIRA), as well as 6-month relapse-associated worsening (RAW) defined as disability onset within 90 days from a relapse, in both the overall population and in recently diagnosed (within 3 years) treatment-naive (RDTN) participants.
In the overall population at year 6, results showed that cumulative event rates were lower in the continuous group compared with the switch group for 6-month CDW (21.09% vs. 24.77%), 6-month PIRA (15.45% vs. 16.56%) and 6-month RAW (5.24% vs 5.81%).
Data further showed that, overall, 80% of study participants on continuous ofatumumab remained free of 6-month CDW, PIRA and RAW events at 6 years.
Regarding RDTN individuals, researchers found that effect sizes for continuous compared with delayed initiation were larger at 6 years: 6-month CDW (16.61% vs. 23.74%); PIRA (11.12% vs. 16.75%); and RAW (4.26% vs 4.82%).
Additionally, cumulative event rates for 6mCDW with ofatumumab compared with teriflunomide initially observed in ASCLEPIOS I/II were sustained in ALITHIOS for up to 6 years, despite switching medications.
“These results further support the use of Kesimpta as a first-line treatment option,” Bar-Or told Healio. “Limitations of the results include a potential for attrition bias and the open-label nature of the extension study.”
Editor's Note: This article was corrected on Oct. 22 to further clarify the timeframe of the results of Kesimpta treatment.