New real-world data show approved MS therapy Kesimpta is safe, effective
Greatest benefits seen with early treatment and among younger patients
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A real-world study found the approved MS therapy Kesimpta helps limit long-term disease progression. (Photo from iStock)
- The approved injection therapy Kesimpta is safe and effective for treating relapsing multiple sclerosis, real-world data show.
- Using Kesimpta was found to help stabilize the progressive disease, reduce relapses, and limit long-term progression among patients.
- Treatment is most effective when started early and in younger patients, researchers say.
The approved injection therapy Kesimpta (ofatumumab) is generally safe and helps most adults with relapsing forms of multiple sclerosis (MS) keep their disease stable over time with few or no relapses, a real-world study has found.
The data show treatment is especially effective when started at a younger age, and before significant disability has developed.
The therapy, an anti-CD20 antibody, is indicated in the U.S. for adults with MS types ranging from clinically isolated syndrome to relapsing-remitting MS and active secondary progressive MS. It is approved in the European Union for similar indications, and can be self-administered by patients at home or on the go.
Overall, the researchers concluded that “these findings support early anti-CD20 therapy as an effective strategy to preserve neurological function and limit long-term progression” in MS.
The study, “Real-world effectiveness and safety of ofatumumab in multiple sclerosis: a longitudinal study integrating clinical, cognitive, and MRI outcomes,” was published in the journal Therapeutic Advances in Neurological Disorders.
A chronic neurological disease, MS is caused by inflammation that damages the protective myelin covering around nerve cells. Over time, accumulating damage leads to long-term disability.
Disease-modifying treatments can reduce the frequency of relapses and lesions on MRI scans, and also slow the gradual worsening of disability. Increasing evidence supports the use of high-efficacy therapies early in the disease, which seem to be more effective for preventing long-term disability. But many countries continue to use an escalation approach, in which high-efficacy therapies are used only after generally safer, more conservative approaches have been tried.
Investigating escalation strategy vs. early high-efficacy therapy use
In this study, a team of researchers in Italy, where this escalation approach is often still used, set out to gather real-world data to define whether that strategy remains acceptable or if people with MS should instead start on a high-efficacy therapy soon after diagnosis.
The team focused on people who were treated with Kesimpta, a high-efficacy therapy for relapsing forms of the neurological disease, at their MS center in Verona.
Kesimpta contains an antibody that attaches to a protein on the surface of immune B-cells, which play a key role in driving MS inflammation. By targeting B-cells, the therapy helps reduce their activity, easing symptoms and slowing the worsening of disability.
A total of 89 adults with relapsing MS were treated with Kesimpta between January and November 2022. On average, these individuals had been living with MS for 9.4 years and were followed for three years after starting Kesimpta.
Over this period, the researchers assessed the response to Kesimpta using a composite measure called no evidence of disease activity, or NEDA-3. Patients achieve and maintain NEDA-3 status if they experience no relapses, no new lesions or lesions with active inflammation on MRI scans, and no confirmed progression of disability.
Over 90% of patients on Kesimpta had no evidence of disease activity
The results showed the vast majority of patients (91%) achieved NEDA-3 during follow-up. Those who did not achieve that status either experienced progression independent of relapse or new MRI activity (8%) or a relapse alongside new MRI activity (1%).
A subgroup of these patients also underwent cognitive assessments during the study, and 37 of the 54 individuals (69%) with available data remained cognitively stable, meeting criteria for NEDA-4, which is a stricter outcome than NEDA-3.
On average, patients who did not maintain NEDA-3 were older (47.7 vs. 39.3 years) and had more disability at the start of treatment than those who maintained NEDA-3. Disability was measured using the Expanded Disability Status Scale (EDSS), which rates the extent to which MS affects walking and other daily functions. A higher EDSS score means more disability.
As with patients who did not maintain NEDA-3, those who failed to maintain NEDA-4 had a higher EDSS score — a median one point more at the start of treatment — than those who maintained NEDA-4, according to the researchers.
This suggests that starting treatment earlier, before disability becomes more advanced, may be linked to greater benefits. Both newly treated patients and those switching from other treatments responded similarly.
These [findings] confirmed the robust short-term efficacy and safety of [Kesimpta] in routine clinical practice, as well as the convenience in maintaining long-term disease control.
Most side effects from the treatment were mild and temporary. The most common was a temporary fever after the first and second injections of Kesimpta, which is given subcutaneously, or under the skin.
Two patients stopped treatment because of side effects. Two others ended treatment because of progression independent of relapses, and one because of new MRI lesions.
The researchers concluded that Kesimpta “provided sustained multidimensional disease control, high NEDA-4 rates, and excellent tolerability” when used in patients with relapsing MS. The team added that these real-world data “[underscore] the importance of early intervention” in people with MS, noting that disability at the study’s start “was the primary predictor of suboptimal response” to treatment.
Overall, according to the scientists, “these [findings] confirmed the robust short-term efficacy and safety of [Kesimpta] in routine clinical practice, as well as the convenience in maintaining long-term disease control.”
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