Researchers analyze switching to Kesimpta from oral therapies

Injecting Kesimpta resulted in less disease activity than oral therapies in relapsing MS

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A patient holds up both hands like a scale while considering two treatment options, one a pill and the other an injection.

People with relapsing multiple sclerosis (MS) who experienced disease activity while on oral therapies had less disease activity after switching to Kesimpta (ofatumumab), according to an analysis of data from the Phase 3 ARTIOS clinical trial.

The patients previously were on Gilenya (fingolimod), or fumarate-based therapies such as Tecfidera (dimethyl fumarate), Vumerity (diroximel fumarate), or Bafiertam (monomethyl fumarate).

After switching to Kesimpta, patients experienced significantly fewer relapses and had less lesions, and few experienced confirmed disability progression over more than one year.

These findings “suggest that patients with breakthrough disease with fingolimod or fumarate-based therapies could benefit from switching” to  Kesimpta, researchers wrote.

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The findings were presented at this year’s annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC), in the poster, “Ofatumumab Effectiveness and Safety in Relapsing Multiple Sclerosis Patients with Breakthrough Disease on Oral Fumarates or Fingolimod: Artios Interim Analysis.” The work was funded by Novartis, which markets Kesimpta.

Kesimpta is an approved treatment for relapsing forms of MS that works by depleting B-cells, a type of immune cell involved in driving the disease. It’s administered via monthly injections under the skin.

Shortly after Kesimpta was first approved, Novartis launched the ARTIOS clinical trial (NCT04353492) with the aim of assessing the therapy in patients who had experienced disease activity (i.e., relapses or new lesions) despite treatment with older oral MS therapies, namely Gilenya or fumarate-based medications.

The trial enrolled more than 500 participants with either relapsing-remitting MS or active secondary progressive MS, and the main goal is to evaluate the effect of Kesimpta treatment on relapse rates over 96 weeks (nearly two years).

The CMSC poster covered an interim analysis that was conducted when about half of participants had been in the trial for at least 48 weeks (about one year), which amounts to about a quarter of the total data that is planned to be collected in the study.

The analysis covered data on 278 participants who had been treated with Kesimpta for at least a year. Among them, 89 had been on Gilenya previously, while the other 189 had been on fumarates. About two-thirds of participants were female and their average age was 37.4 years.

Significant reduction in relapses

In the year prior to entering the trial, patients had experienced an average of 0.9 relapses per year. After one year of Kesimpta treatment in the trial, the relapse rate was reduced significantly, to 0.12 relapses per year.

The number of lesions with active inflammation also significantly decreased after patients switched to Kesimpta. After a year on Kesimpta, the average number of active lesions was 97.4% lower than that seen in MRI scans taken at the trial’s start. A similar reduction was seen in the total number of new or enlarging lesions.

Only nine patients (less than 4% of all participants) experienced a confirmed worsening of disability scores, as measured with the Expanded Disability Status Scale, over a year on Kesimpta.

And finally, average blood levels of neurofilament light chain (NfL, a marker of nerve damage) also decreased after patients switched to Kesimpta, with significant differences being observed as early as six months after treatment.

“The ARTIOS Phase 3b late-breaking data presented at the 2023 Consortium of Multiple Sclerosis Centers congress show that patients receiving Kesimpta had adjusted annualized rate of relapse of 0.12 and near-complete suppression of MRI lesion activity at week 48, with no new safety signals observed. These are all important findings for people living with relapsing multiple sclerosis,” Dharmesh Patel, MD, vice president, medical unit head, neuroscience at Novartis, said in an email to Multiple Sclerosis News Today.

Consistent with prior studies

Safety data in ARTIOS have been consistent so far with prior studies of Kesimpta, with no apparent differences based on which therapy patients had been on previously. Most reported side effects were not deemed serious, and among the 3.2% of patients who did experience serious side effects, all were resolved with appropriate care.

“We are encouraged that the interim results continue to reinforce the efficacy and safety profile of Kesimpta in patients with RMS [relapsing forms of MS], and look forward to reporting the full data at a future congress and furthering our research as part of our ongoing commitment to the RMS community,” Patel added.