Mild disease activity is a definition by Novartis based on the average patient characteristics in the ASCLEPIOS I II trials.

Efficacy

Meaningful efficacy: From the start and for the long term

Safety profile

Well-established long-term safety profile^{6, 7}

Confidence from Day 1 to Year 7 in both naïve and switch patients – no new safety signals from the 6-year findings or increased risk of serious infections in up to 7 years of continuous KESIMPTA treatment in patients with RMS.^{6, 7}

Please refer to the SmPC for further information.

The safety profile of KESIMPTA was maintained for up to 7 years of treatment⁶
 

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The RDTN subgroup refers to patients who were recently diagnosed (≤ 3 years) and treatment-naïve.⁴

EAIR per 100 patient-years is defined as the expected number of patients with the given event over 100 years of exposure to a treatment, assuming the event rate is constant over time.⁴
*IgG levels remained > LLN (5.65 g/L) in 98% of participants in all assessments. The proportion of participants who interrupted KESIMPTA due to low IgG or IgM was 0.4% / 14.4%, respectively.⁶

*Once monthly dosing begins after initial dosing periods at Weeks 0, 1, and 2. Mean overall handling time of 1-minute-a-month per injection includes time to prepare the pen.¹^,⁸
† Administration time varies by product.
‡ Patient must take the pen out of the refrigerator 15–30 minutes before self-administering. Actual injection only takes 3–4 seconds, but additional time is required to prepare the pen and clean the administration site.¹
§ Data from two real-world surveys evaluating experience with the Sensoready® pen. 9, 10 US-based survey (N = 105): Assessed overall satisfaction, device usability, and injection experience among adults with RMS self-administering KESIMPTA within the previous 12 months.¹⁰ Multicenter survey (N = 130; 80 patients, 50 MS nurses): Conducted in the US, Germany, France, and Italy to assess preferences for the Sensoready® pen vs. other MS autoinjectors.⁹

*There are no premedication or drug administration monitoring requirements, and no dose modifications.¹ In two real-world studies, both patients and nurses preferred the Sensoready® pen over other autoinjectors for its ease of use, preparation, and set-up, with 9 out of 10 patients finding it easy to self-administer. ^9,10
† ‘1-minute-a-month’ refers to the time it takes for a patient to inject a full dose of KESIMPTA after preparation.⁸ The initial dosing period consists of 20mg subcutaneous doses at Weeks 0, 1 and 2. Patients must take the pen out of the refrigerator 15–30 minutes before self-administering. Actual injection only takes 3–4 seconds, but additional time is required to prepare the pen and clean the administration site. The first injections should be performed under the guidance of a healthcare professional.¹

Abbreviations:

6mCDW = 6-month confirmed disability worsening; 6mPIRA = 6-month progression independent of relapse activity; AE = adverse event; ARR = annualised relapse rate; BL = baseline; CI = confidence interval; EAIR = exposure-adjusted incidence rate; ECG = electrocardiogram; EDSS = Expanded Disability Status Scale; Gd+ = gadolinium-enhancing; IgG = immunoglobulin G; IgM = immunoglobulin M; LLN = lower limit of normal; MRI = magnetic resonance imaging; MS = multiple sclerosis; NEDA = no evidence of disease activity; ns = non-significant; PIRA = progression independent of relapse activity; RDTN = recently diagnosed treatment naïve; RMS = relapsing multiple sclerosis; SAE = serious adverse event; SC = subcutaneous; SE = standard error.

Reference:

1. KESIMPTA Summary of Product Characteristics.

2. Hauser SL et al. Continuous ofatumumab treatment for up to 7 years shows a favourable safety and efficacy profile in people with relapsing multiple sclerosis. Poster P804 presented at ECTRIMS 2025, Barcelona, Spain.

3. Hauser SL et al. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med 2020;383(6):546-557.

4. Bittner S et al. Continuous ofatumumab treatment for up to 7 years shows a consistent safety and efficacy profile in recently diagnosed treatment-naive people living with relapsing multiple sclerosis. Poster P805 presented at ECTRIMS 2025, Barcelona, Spain.

5. Nelles G et al. Longer-term (up to 6 years) efficacy and safety of ofatumumab in people with non-highly active MS early in the disease course. Poster IOP014 presented at Deutsche Gesellschaft für Neurologie 2024, Berlin, Germany.

6. Pardo G et al. Continuous ofatumumab treatment up to 7 years shows a consistent safety profile and delays disability progression in people with relapsing multiple sclerosis. Poster P7.016 presented at the American Academy of Neurology Meeting 2025, San Diego, CA, USA.

7. Ziemssen T et al. Over 7 years, the risk of serious infections remained low with long-term ofatumumab treatment in people with relapsing multiple sclerosis. Poster 812 presented at ECTRIMS 2025, Barcelona, Spain.

8. Terlizzi RD, King M and Blohm C. Usability validation of the Sensoready® pen in patients with relapsing multiple sclerosis. Ther Deliv 2023;14(4):259-268.

9. Ross AP et al. Patient and nurse preference for Sensoready autoinjector pen versus other autoinjectors in multiple sclerosis: Results from a pilot multicenter survey. BMC Neurol 2023;23(1):85.

10. Ross AP et al. Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis. BMC Neurol 2025;25(1):28.

11. Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler 2022;28(10):1576-1590.

12. ClinicalTrials.gov. Long-term safety, tolerability and effectiveness study of ofatumumab in patients with relapsing MS (ALITHIOS). https://clinicaltrials.gov/study/NCT03650114 [Accessed November 2025].

December 2025 - FA-11522068