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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.
KESIMPTA efficacy
Click on the buttons below to explore the analyses from the ASCLEPIOS pivotal studies and the ALITHIOS open-label extension study.
Explore ASCLEPIOS and ALITHIOS study designs
KESIMPTA has demonstrated efficacy in ASCLEPIOS I and II (2-year core studies), two Phase III randomised, double-blind, double-dummy, active comparator-controlled, parallel-group, multicentre pivotal trials, comparing a range of outcomes to active comparator teriflunomide in 1882 patients with RMS, following patients for up to 6 years (including the 4-year extension phase, ALITHIOS study).1–3
ALITHIOS is an ongoing, open-label, single-arm, umbrella-extension, Phase IIIb study assessing the risk–benefit profile of KESIMPTA (20 mg subcutaneously every 4 weeks) and its tolerability in patients with RMS.4
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Adapted from Hauser SL, et al. 2022.4
ASCLEPIOS I and II primary endpoint: annualised relapse rate (ARR) was defined as the number of confirmed relapses of multiple sclerosis (MS) per year, according to prespecified criteria.3
ASCLEPIOS I and II secondary endpoints: disability worsening confirmed (CDW) at 3 months and 6 months, disability improvement confirmed (CDI) at 6 months, the number of gadolinium-enhancing (Gd+) lesions per T1-weighted magnetic resonance imaging (MRI) scan, the annualised rate of new or enlarging lesions on T2-weighted MRI, serum neurofilament light chain levels (NfL) at Month 3, and brain volume change (BVC).3
KESIMPTA met the primary endpoint in ASCLEPIOS I/II, with up to 58% reduction in ARR vs teriflunomide (ASCLEPIOS I: 51% [0.11 vs 0.22]; RR: 0.49 [95% CI: 0.37–0.65]; ASCLEPIOS II: 58% [0.10 vs 0.25]; RR: 0.42 [95% CI: 0.31–0.56]; both p<0.001).1,3
A low ARR* was observed in patients treated with KESIMPTA up to Year 75
Use the arrows below to navigate to the 7-year recently-diagnosed (≤3 years) treatment-naïve (RDTN) data.
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*ARR was defined as the number of confirmed MS relapses per year, according to prespecified criteria. Confirmed relapses are those accompanied by a clinically relevant change in expanded disability status scale (EDSS).2
9 out of 10 patients on KESIMPTA were observed to have no evidence of disease activity-3 (NEDA-3) at Year 7 (post-hoc analysis)5
NEDA-3 was determined in a post-hoc analysis of pooled ASCLEPIOS trials and open-label extension study.2,5
Data from exploratory analysis is descriptive, and no confirmatory clinical conclusions can be drawn.
Use the arrows below to navigate to the 7-year NEDA-3 and RDTN subgroup data.
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Significant and near-complete suppression of MRI lesion activity up to 7 years in overall and RDTN patients5,6
Within-group comparisons during the extension phase for ASCLEPIOS and ALITHIOS (RDTN subgroup, N=465)**6
In the overall population (N=1367):5
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**Diagnosed ≤3 years and DMT naive.
Confirmed disability worsening at 7 years7
Use the arrows below to navigate to the RDTN subgroup data.
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6m CDW was defined as an increase from baseline in EDSS score (≥1.5, ≥1 or ≥0.5 points for patients with a baseline EDSS score of 0, 1–5 or ≥5.5, respectively) sustained for ≥6 months. Time to first event rates were assessed using Kaplan–Meier estimates. For core+extension, p values were obtained using the log-rank test.7
PIRA at 7 years (exploratory endpoint)7
Use the arrows below to navigate to the RDTN subgroup data.
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Data from exploratory analyses are descriptive, and no confirmatory clinical conclusions can be drawn.
6m PIRA was defined as a 6m CDW event with either no prior relapse or an onset more than 90 days after the start date of the last investigator-reported relapse. Additionally, to qualify as a PIRA event, no relapse must have occurred within 30 days after confirmation of EDSS worsening.7
Continuous KESIMPTA treatment showed an observed reduction in serum NfL levels versus teriflunomide from 12 months to 4 years (observational data)8
Serum NfL levels during the overall period8
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Adapted from Alvarez E, et al. 2023.8
Switching from teriflunomide to KESIMPTA resulted in an observed decline in serum NfL levels during the open-label extension period, which converged over time8
The most important and frequently reported adverse reactions are upper respiratory tract infections (39.4%), systemic injection-related reactions (20.6%), local injection-site reactions (10.9%) and urinary tract infections (11.9%).1
This is not an exhaustive list of adverse reactions; please refer to the KESIMPTA Summary of Product Characteristics for more details.1
Learn more about the KESIMPTA safety profile
*ARR was defined as the number of confirmed MS relapses per year, according to prespecified criteria. Confirmed relapses are those accompanied by a clinically relevant change in expanded disability status scale (EDSS).2
†ARRs are obtained from fitting a piecewise negative binomial model for the time period core phase and extension phase with log-link, adjusted for treatment and region as factors and number of relapses in previous year, baseline EDSS, baseline number of Gd+ lesions, and the participant’s age at baseline as covariates. The natural log of the time-in-study (in years) by period is used as offset to ARR in each period. Baseline variables are from the core study baseline. All p values are nominal p values. RDTN was defined as ≤3 years from diagnosis.6
‡Estimated from fitting a piecewise negative binomial model for the time period core phase and extension phase with log-link, adjusted for treatment as factor and baseline number of T1 Gd+ lesions and participant’s age at baseline as covariates. The natural log of the number of scans with evaluable Gd+ lesion counts by period is used as offset to obtain the lesion rate per scan in each period. Baseline variables are from the core study baseline. All p values are nominal p values.6
6m, 6-month; ABVC, annual rate of brain volume change; ARR, annualised relapse rate; CDI, confirmed disability improvement; CDW, confirmed disability worsening; CI, confidence interval; EDSS, expanded disability status scale; Gd+, gadolinium-enhancing; HR, hazard ratio; MRI, magnetic resonance imaging; MS, multiple sclerosis; NEDA-3, no evidence of disease activity-3; NfL, neurofilament light chain; OR, odds ratio; PIRA, progression independent of relapse activity; RDTN, recently-diagnosed treatment-naïve; RMS, relapsing forms of multiple sclerosis; RR, rate ratio.
References
KESIMPTA (ofatumumab) Summary of Product Characteristics. Available at www.medicines.ie.
Wiendl H, et al. Poster P9.010. American Academy of Neurology Annual Meeting. 13–18 April 2024, Denver, CO, US.
Hauser SL, et al. New Engl J Med 2020;383(6):546–557.
Hauser SL, et al. Mult Scler J 2022;28(10):1576–1590.
Hauser SL, et al. Poster P804. European Committee for Treatment and Research in Multiple Sclerosis Annual Congress. 24–26 September 2025, Barcelona, Spain.
Bittner S, et al. Poster P805. European Committee for Treatment and Research in Multiple clerosis Annual Congress. 24–26 September 2025, Barcelona, Spain.
Pardo G, et al. Poster P7.016. American Academy of Neurology Annual Meeting. 5–9 April 2025, San Diego, CA, US.
Alvarez E, et al. P6013. American Academy of Neurology Annual Meeting. 22–27 April 2023, Boston, MA, US.
IE11499623 | July 2026
