No Disease Activity After 4 Years for Nearly 80% of Patients on Kesimpta

People with relapsing forms of multiple sclerosis (MS) who were continuously on Kesimpta (ofatumumab) for up to four years were about four times more likely to have no evidence of disease activity than those initially on Aubagio (teriflunomide), according to updated data from the ASCLEPIOS and ALITHIOS clinical trials.

The new data was presented at the European Academy of Neurology (EAN) annual meeting, held in Vienna and virtually June 25–28. The presentation was titled, “Longer-term Efficacy of Ofatumumab in Patients with Relapsing Multiple Sclerosis.”

Kesimpta is an anti-CD20 monoclonal antibody that’s approved to treat relapsing types of MS. The therapy is administered monthly via subcutaneous (under-the-skin) injections and it works by depleting inflammatory B-cells that drive the disease.

Approvals of Kesimpta were based on data from the Phase 3 clinical trials ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231), which collectively enrolled more than 1,800 patients with relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).

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Participants were randomly assigned to Kesimpta or Aubagio, an approved oral MS treatment, for up to 2.5 years. Results showed Kesimpta significantly outperformed Aubagio at lowering relapse rates, preventing disability worsening, and decreasing disease activity on MRI scans.

After the ASCLEPIOS trials were completed, about 90% of the participants elected to continue into an open-label extension study called ALITHIOS (NCT03650114), wherein all participants were treated with Kesimpta. At the EAN meeting, researchers at Novartis, which markets Kesimpta, and other institutions presented trial data for up to four years of treatment.

Results showed that nearly four out of five (78.8%) of the participants who had been on Kesimpta for the duration of the trials showed no evidence of disease activity (NEDA-3) — defined as no relapses, no worsening disability, and no new inflammatory activity on MRI scans.

“NEDA-3 is an important endpoint for physicians to consider when deciding to initiate high efficacy therapy,” Ludwig Kappos, a professor at University Hospital Basel who presented the findings, said in a Novartis press release.

In contrast, among those who had originally been on Aubagio in the ASCLEPIOS trials and then switched to Kesimpta upon entering ALITHIOS, the NEDA-3 rate was 51.8%. Statistical analyses showed that participants who started on Kesimpta were nearly four times more likely to achieve NEDA-3, compared with those who started on Aubagio.

“Early initiation of high-efficacy therapies for the treatment of relapsing multiple sclerosis has been shown to improve long-term outcomes versus escalating from lower efficacy therapies,” Kappos said. “With this latest data from ALITHIOS we can clearly see the benefit of starting Kesimpta early versus switching to it later from [Aubagio].”

In a separate presentation at EAN, researchers shared analyses of scores on the Symbol Digit Modalities Test (SDMT) — a standardized measure of cognition that requires a person to substitute numbers or letters for abstract symbols using a reference key — during the ASCLEPIOS trials.

The presentation was titled, “Improvement in Cognitive Processing Speed with Ofatumumab in Patients with Relapsing Multiple Sclerosis.”

Comparing SDMT scores at the study’s start to scores after two years indicated Kesimpta generally led to cognitive processing speed improvements.

The percentage of patients who experienced a sustained improvement of at least four points, suggesting a markedly better cognitive ability, was significantly higher among those on Kesimpta compared to those on Aubagio (25% vs. 19.6%). The likelihood of such an improvement was about 14% higher for those on Kesimpta than on Aubagio, according to statistical analyses.

Analyses of patients who had recently been diagnosed at the trial’s start generally found consistent results.

The scientists concluded Kesimpta “was associated with more clinically meaningful improvements in [cognitive processing speed] versus [Aubagio] when measured by change in SDMT in both the overall and [recently diagnosed] populations.”