#AAN2022 – Data from Multiple Trials Show Kesimpta’s Safety, Efficacy

Treatment with Kesimpta (ofatumumab) for more than three years revealed no new or unexpected safety findings, and continued to slow disability progression and prevent the development of new brain lesions in people with relapsing multiple sclerosis (MS), according to new clinical trial data.

Information from another trial also showed that people treated with Novartis‘ Kesimpta can still mount an effective immune response after receiving a vaccine for COVID-19.

The findings were presented in three posters and one oral presentation at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in person April 2–7 in Seattle, Washington, and virtually April 24–26.

“We are pleased to share long-term data of up to four years that support Kesimpta as an efficacious and well-tolerated, first-choice option for people living with relapsing multiple sclerosis,” Lykke Hinsch Gylvin, MD, neuroscience global medical franchise head at Novartis, said in a press release.

Kesimpta is an approved therapy for relapsing MS that is administered via an injection under the skin once a month.

The Phase 3 clinical trials ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231), which served as the basis for the therapy’s approval, compared Kesimpta against the approved oral MS therapy Aubagio (teriflunomide). Results showed that Kesimpta outperformed Aubagio at reducing relapse rates, delaying disability progression, and preventing brain lesions.

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Participants in the ASCLEPIOS studies, and some other clinical trials testing Kesimpta, had the option to enroll in a long-term extension study called ALITHIOS (NCT03650114). The study enrolled nearly 2,000 participants, including 1,292 treated with Kesimpta throughout the trials, and 677 who switched from Aubagio to Kesimpta upon entering the extension study.

Data for up to four years of treatment continue to support Kesimpta’s ability to delay disability progression and prevent brain lesions in MS patients. Results were presented at the AAN meeting in the poster, “Long-term Efficacy of Ofatumumab in Patients With Relapsing Multiple Sclerosis.”

“The sustained reductions in disability progression and lesion activity observed in those receiving continuous Kesimpta versus those who switched later from [Aubagio] highlight the value of earlier treatment initiation with Kesimpta,” Gylvin said.

Long-term safety results, discussed in the oral presentation, “Long-term Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis,” were broadly in line with earlier data for Kesimpta.

After up to about 3.5 years of treatment, 83.8% of participants experienced at least one adverse event (side effect), and 9.7% had at least one serious adverse event. Serious infections were reported in 2.9% of participants, and 0.6% developed cancer.

Systemic injection-related reactions, such as fever, headache, chills, or fatigue, occurred overall in about one of every four Kesimpta-treated patients in ALITHIOS. Local injection reactions, like redness or pain, occurred in about one of 10 patients overall.

Almost all (99.5%) of the injection site reactions were mild-to-moderate in severity, and none of the reactions in the study were life-threatening. Injection site reaction data were detailed in the poster, “Injection-Related Reactions with Subcutaneous Administration of Ofatumumab in Relapsing Multiple Sclerosis: Data from Clinical Studies and Post Marketing Experience.”

Kesimpta works by killing B-cells, a type of immune cell involved in the inflammation that drives MS. B-cells also are responsible for making antibodies, a type of immunological protein that is critical for protecting the body against viruses and other infectious invaders.

Data from ALITHIOS showed that, after up to four years, levels of a type of antibody called immunoglobulin G (IgG) were stable in Kesimpta-treated patients. Another type of antibody called immunoglobulin M (IgM), which is generated earlier in the body’s response to infections, decreased with Kesimpta treatment. However, levels remained within a range that is considered normal. No association was detected between antibody levels and the risk of serious infection.

Activating an antibody response is one of the primary ways COVID-19 vaccines confer protection against the virus. Novartis is running an open-label Phase 4 trial called KYRIOS (NCT04869358) that is testing the effectiveness of COVID-19 mRNA vaccines in MS patients before or during treatment with Kesimpta.

KYRIOS is currently recruiting participants at several sites in Germany. Findings from the ongoing study were shared in a poster titled, “Tracking the immune response to SARS-CoV-2 mRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS clinical trial).”

Data suggest that Kesimpta-treated patients can mount an immune response to the vaccines. All participants vaccinated during continuous Kesimpta treatment developed a detectable immune response as soon as one week after getting a first vaccination. Also, immune responses to a vaccine booster were similar in patients who received the booster before or during Kesimpta treatment.

“KYRIOS data show for the first time that patients vaccinated during stable [Kesimpta] treatment can mount immune responses to [COVID-19] mRNA vaccines,” the researchers concluded.

“During this pandemic, it is critical for people living with multiple sclerosis to have access to safe and efficacious treatments that do not interfere with their vaccine doses,” Gylvin said.

Note: The Multiple Sclerosis News Today team is providing coverage of the American Academy of Neurology (AAN) 2022 Annual Meeting. Go here to see the latest stories from the conference.