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Prescribing information

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In Ireland, KESIMPTA® (ofatumumab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.1

For full safety information, please refer to the KESIMPTA Summary of Product Characteristics.

Start high-efficacy treatment early

Starting high-efficacy treatment early has been observed to show favourable long-term outcomes compared with stepwise escalation of therapy*2–4

In a retrospective cohort study of patients with RRMS from the Swiss National Treatment Registry (2007–2023):2

  • 450 patients with RRMS had been maintained on low-efficacy DMTs for ≥2 years and were subsequently escalated to either medium-efficacy DMTs (n=225) or high-efficacy DMTs (n=225; primary analysis). The matching yielded 225 well-balanced pairs†

  • Each escalating group was then matched separately with control patients who remained on low-efficacy DMTs (secondary analysis)

KESIMPTA was not used in this study and therefore results must not be extrapolated.

Low-efficacy DMTs included interferon beta-1a, peginterferon beta-1a, interferon beta-1b, glatiramer acetate, teriflunomide; medium-efficacy DMTs included fingolimod, dimethyl fumarate, ponesimod, ozanimod; and high-efficacy DMTs included ocrelizumab and natalizumab.2

Initiating high-efficacy treatment early can help preserve neurological function and reduce disability worsening compared with escalation from low–moderate-efficacy therapy, potentially allowing patients to maintain their current functioning and quality of life2–4

Probability of being relapse-free over time by escalation cohort2

Primary analysis: up to 7 years, escalation to high-efficacy DMTs was associated with an observed reduced risk of relapses vs medium-efficacy DMTs (HR: 0.67; 95% CI: 0.47–0.95; p=0.027). The median follow-up to pair-wise censoring was 1.9 years, during which 125 outcome events occurred; 73 (58%) in patients switching to MET and 52 (42%) in those switching to HET.2

 

Primary analysis

ine graph showing the probability of being relapse-free over time by escalation cohort in primary analysis of a Swiss National Treatment Registery study.

Adapted from Müller J, et al. 2024.2

 

Secondary analysis: up to 9 years, escalation from low- to medium-efficacy DMTs did not find any evidence of a difference in the cumulative hazards of relapses when compared with control patients on low-efficacy DMTs who did not escalate treatment (HR: 1.19; 95% CI: 0.89–1.60, p=0.2). At a median follow-up of 2.9 years, relapses occurred in 87 (48.6%) of the patients escalating to MET and 92 (51.4%) patients in the control group.2

 

Secondary analysis

Line graph showing the probability of being relapse-free over time by escalation cohort in secondary analysis of a Swiss National Treatment Registery study.

Adapted from Müller J, et al. 2024.2

Escalation from low- to high-efficacy therapy is associated with an observed reduction in the risk of relapses, while a stepwise escalation from low- to medium-efficacy therapy may not affect relapse risk2

Discover how treating with a high-efficacy treatment may potentially impact the lives of eligible patients with RRMS

Find out more

*Better outcomes in terms of risk of relapse, ARR and EDSS.2–4
†To balance the groups for their baseline characteristics, the propensity of treatment escalation strategy was estimated using a multivariable logistic regression model with treatment allocation as outcome and age, sex, disease duration, EDSS, previous treatment, duration on the previous treatment, number of previous treatments, number of relapses in the prior 1 and 2 years, total number of prior relapses, and time since last relapse as independent variables. Nearest neighbour matching was used in a 1:1 ratio, with a calliper of 0.2 SD of the propensity score, without replacement. Patients who were escalated from low-efficacy to medium-efficacy treatment vs from low-efficacy treatment to high-efficacy treatment were matched first. Subsequently, each of these groups was matched separately with the controls.2

ARR, annualised relapse rate; CI, confidence interval; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; HET, high-efficacy treatment; HR, hazard ratio; MET, medium-efficacy treatment; RMS, relapsing forms of multiple sclerosis; RR, rate ratio; RRMS, relapsing-remitting multiple sclerosis; SD, standard deviation.

References

  1. KESIMPTA (ofatumumab) Summary of Product Characteristics.. Available at www.medicines.ie.

  2. Müller J, et al. Brain Behav 2024;14(5):e3498.

  3. Harding K, et al. JAMA Neurol 2019;76(5):536–541.

  4. He A, et al. Lancet Neurol 2020;19(4):307–316.

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ASCLEPIOS and ALITHIOS clinical trials and efficacy

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Downloadable resources

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Safety profile
 

IE11499633 | June 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.