KESIMPTA® (ofatumumab) is the first and only self-administered SC B-cell RMS treatment1,3
1
Powerful overall efficacy vs Aubagio® (teriflunomide) in Phase 3 trials1*
No evidence of disease activity (NEDA-3) for 9 out of 10 patients at year 64†‡
Safety profile proven over 6 years4
Components of immune function may be maintained in KESIMPTA patients1,4-6§
1 minute a month when the patient is ready to self-administer via easy-to-use pen1,2,7,8||¶
Start patients today with samples#
The first choice matters
Start your treatment-naïve patients on KESIMPTA today
*As evidenced by ARR, MRI (Gd+ T1 and T2 lesions), and 3- and 6-month CDP. Primary end point, ARR reduction of 51% (0.11 vs 0.22), 58% (0.10 vs 0.25).1
†Limitations: This analysis considers patients without evidence of disease activity (which may also include patients with partially missing information) as NEDA-3. A sensitivity analysis was conducted for the population of patients who completed the full 24 months of treatment.9 No conclusions of clinical outcomes can be drawn.
‡NEDA-3 post hoc analysis design: All patients from the pivotal trials, full analysis set population (all randomized patients with assigned treatments) who also received KESIMPTA in the ALITHIOS extension study (data cutoff: September 25, 2023) were included in the intent-to-treat principle, but patients who discontinued from the study drug prematurely for reasons other than “lack of efficacy” or “death” and had NEDA-3 before early discontinuations were excluded. The outcomes presented here are the proportion of study patients within a treatment group who met the NEDA-3 criteria vs those who did not. The proportion of patients meeting NEDA-3 criteria was analyzed cross-sectionally in 1-year time intervals across 6 years. Within the prespecified time period, patients who achieved NEDA-3 experienced no 6-month CDP; no confirmed relapse; no Gd+ T1 lesions; no NE T2 lesions; and no discontinuation from the study drug due to either lack of efficacy or death.4,9
§The precise mechanism by which KESIMPTA exerts its therapeutic effects is unknown. The clinical relevance of these data is unknown. Preclinical evidence suggests that KESIMPTA may spare B cells in the spleen that help maintain immune function. A post hoc analysis of a Phase 2 RMS clinical study showed that T cells remained largely unaffected with KESIMPTA. Data from an extension analysis of Phase 3 data showed mean IgG levels remained stable for up to 6 years in KESIMPTA patients.1,4-6
||As per stability technical specification data, when the patient is ready to inject, it typically takes less than 1 minute a month to administer. Once-monthly dosing begins after the initial dosing period, which consists of 20 mg subcutaneous doses at weeks 0, 1, and 2. Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.1,2
¶Based on a survey of adult RMS patients (N=105) in the US who self-administered KESIMPTA within the previous year. 89.5% of patients scored a 4 or 5 on ease of use. Questionnaire has not been validated.7,8
#Sample program is only available to patients who are determined to be appropriate candidates for treatment with KESIMPTA and is intended to give patients a chance to see if KESIMPTA may be right for them.
ARR, annualized relapse rate; CDP, confirmed disability progression; Gd+, gadolinium-enhancing; IgG, immunoglobulin G; MRI, magnetic resonance imaging; MS, multiple sclerosis; NE, new or enlarging; RMS, relapsing multiple sclerosis; SC, subcutaneous.
References: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 2. Data on file. Injection time. Novartis Pharmaceuticals Corp; East Hanover, NJ. June 2020. 3. National Multiple Sclerosis Society. Injectable Therapies. Accessed May 28, 2024. https://www.nationalmssociety.org/article/injectable-therapies 4. Wiendl H, Hauser SL, Nicholas J, et al. Longer-term safety and efficacy of ofatumumab in people with relapsing multiple sclerosis for up to 6 years. P9.010. Presented at: 76th American Academy of Neurology Annual Meeting; April 13-18, 2024; Denver, CO. 5. Theil D, Smith P, Huck C, et al. Imaging mass cytometry and single-cell genomics reveal differential depletion and repletion of B-cell populations following ofatumumab treatment in cynomolgus monkeys. Front lmmunol. 2019;10:1340. doi:10.3389/fimmu.2019.01340. 6. Wiendl H, Fox E, Goodyear A, et al. Effect of subcutaneous ofatumumab on lymphocyte subsets in patients with RMS: analysis from the APLIOS study. LB129. Presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020; Paris, France; Virtual. 7. Ross AP, Nicholas J, Tai MH, et al. Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis. LB09. Presented at: Consortium of Multiple Sclerosis Centers Annual Meeting; May 31-June 3, 2023; Aurora, CO. 8. Novartis KESIMPTA Sensoready® pen survey HEORUSV201392. June 2022. 9. Data on file. OMB157G (ofatumumab). Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.