CMSC 2026: Kesimpta outperforms Aubagio in highly active relapsing MS
Patients nearly 20 times more likely to achieve absence of relapses
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A hand holding a blue marker is seen next to a stethoscope and a stack of small Sticky Note pads, with the words "clinical trials" written on the top sheet in blue. (Photo by iStock)
- Kesimpta was more effective than Aubagio for highly active relapsing multiple sclerosis.
- It was much more likely to reduce relapses, MRI lesion activity, and disability progression over two years.
- Kesimpta showed a similar safety profile in this subgroup to that observed in the trials' overall population.
Kesimpta (ofatumumab) was more effective than Aubagio (teriflunomide) at suppressing disease activity in people with highly active, relapsing forms of multiple sclerosis (MS), according to new analyses from the Phase 3 ASCLEPIOS trials.
After two years, those on Kesimpta were nearly 20 times more likely to achieve a composite outcome characterized by an absence of relapses, new MRI activity, and confirmed disability progression.
The data also suggest that the therapy has a similar safety profile in this subgroup of people with highly active disease to that observed in the trials’ overall population.
The data were presented last week at the 2026 annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) by Patricia Coyle, MD, of Stony Brook University in New York. The talk was titled “Efficacy and Safety of Ofatumumab vs Teriflunomide in Participants With Highly Active Relapsing Multiple Sclerosis: Subgroup Analysis From ASCLEPIOS I/II.”
“In this subgroup of relapsing MS with highly active disease … [Kesimpta] versus [Aubagio] was associated with a substantially lower annualized relapse rate, a very marked suppression of MRI lesion activity, [and] numerically fewer individuals that met … confirmed disability worsening,” Coyle said.
Kesimpta works to deplete levels of B-cells involved in inflammation
Kesimpta, from Novartis, is a monthly injectable therapy that works to deplete levels of immune B-cells, which are heavily involved in the inflammatory attacks that damage the brain and spinal cord in MS.
In the U.S. and elsewhere, it is used to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
These approvals were supported by data from the Phase 3 ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) trials, which compared Kesimpta with Aubagio in 1,882 people with RRMS or active SPMS.
The data from the overall population showed that Kesimpta was superior to Aubagio for reducing disease activity, including clinical relapses and lesions on MRI scans, and delaying disability progression.
Among participants with early MS and low disease activity, Kesimpta was similarly efficacious, resulting in near-complete resolution of inflammatory disease activity, Coyle said.
Lesions with active inflammation almost completely suppressed
In the recent exploratory analysis, investigators examined efficacy outcomes in the subgroup of participants on the opposite end of the spectrum — those with highly active disease. That was defined as those who had at least one active, inflammatory lesion at the study’s start and had experienced at least two relapses in the year before trial entry.
Ultimately, the analysis included 212 individuals, including 101 who received Kesimpta and 111 who received Aubagio.
The results showed that Kesimpta “substantially lowered” the annualized relapse rate, or the mean number of relapses per year, by nearly 50% compared with Aubagio, according to Coyle.
Moreover, the number of lesions with active inflammation per MRI scan was almost completely suppressed — a reduction of 97.3% compared with Aubagio. The annual rate of new or enlarging brain lesions also dropped by 81.5%.
Notably, a significantly higher proportion of people on Kesimpta were entirely free of relapses, confirmed disability progression at six months, and MRI activity — a composite outcome measure called No Evidence of Disease Activity-3 (NEDA-3) — than in the Aubagio group.
In the first year, 21.7% of people on Kesimpta and 8.4% of those on Aubagio achieved NEDA-3, with those on Kesimpta being over three times more likely to achieve NEDA-3. In the second year, 79.5% and 19.5% of patients on Kesimpta and Aubagio achieved this outcome, meaning those on Kesimpta were nearly20 times more likely to achieve it.
[The data demonstrate] strong efficacy and safety in participants with highly active MS, supporting [Kesimpta] initiation in this sort of patient.
People on Kesimpta experienced about 50% fewer confirmed disability worsening events than those on Aubagio, including disability worsening that was sustained for three months or six months.
In addition, blood levels of neurofilament light chain, a biomarker of nerve damage, were lower with Kesimpta compared with Aubagio.
Safety findings were consistent with earlier analyses from the trials.
“From a safety point of view, there’s nothing particularly striking that comes out,” Coyle noted.
B-cell-targeting therapies such as Kesimpta can deplete antibodies the body uses to fight infections. Among the study participants, antibody levels remained relatively stable, with most participants maintaining normal levels throughout the study.
Overall, the data demonstrate “strong efficacy and safety in participants with highly active MS, supporting [Kesimpta] initiation in this sort of patient,” Coyle concluded.
Note: The Multiple Sclerosis News Today team is providing live coverage of the Consortium of MS Centers Annual Meeting, May 27-29. Go here to see the latest stories from the meeting.
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