Prescribing information (external link)
All patient imagery on this webpage is fictional and used for illustrative purposes only.
Women of childbearing potential should use effective contraception (methods that result in <1% pregnancy rates) while receiving KESIMPTA® for 6 months after the last administration. Please consult the SmPC for full details.
Welcome to the KESIMPTA® homepage
KESIMPTA® is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.1
For full safety information, please refer to the KESIMPTA® Summary of Product Characteristics (SmPC).1 Learn more about the KESIMPTA safety profile.
Start their active RMS treatment journey with KESIMPTA®
Long term efficacy data and a generally consistent safety profile across clinical trials for up to 8 years in people with RMS.2,3
With a safety profile consistent with pivotal trials and no new unexpected safety concerns identified for up to 8 years,† KESIMPTA® is the only subcutaneous B-cell therapy backed by up to 8 years of clinical and 5 years of real-world data.2–4
Start their active RMS treatment journey with KESIMPTA®
Explore long‑term evidence for KESIMPTA® in RMS. Select an area to review key endpoints and study context:
Treatment naïve patients with mild disease activity – like Sofia
A 25-year-old marketing executive recently diagnosed with RMS, concerned about relapses impacting her career.
Patients considered clinically stable on current therapy – like Marco
A 39-year-old travel blogger who worries about adverse events from his current treatment interfering with his activities when he's away from home.
Patients switching from MET due to breakthrough disease activity – like Hannah
A 35-year-old chef seeking an effective treatment that fits her routine.
Patients switching for flexibility/ease of use – like Aleena
A 32-year-old healthcare assistant who would prefer the control and convenience of managing RMS at home with self-administration.
The efficacy & safety profile of KESIMPTA® was evaluated in 2 RCT's (ASCLEPIOS I & 2) in RMS. Patients included were aged 18-55 years, a disability status at screening with an EDSS score from 0-5.5, & who had experienced at least 1 documented relapse during the previous year or 2 relapses during the previous two years or positive gadolinium (Gd)-enhancing MRI scan during the previous year. Both newly diagnosed patients & patients switching from their current treatment were enrolled.1
Not real patients. All points are fictional representations of a typical RMS patient. Individual patient experiences and symptoms may vary from patient to patient. Please refer to the SmPC for further information about typical responses.
Which of your patients could benefit from KESIMPTA®?
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).1,4
Click to 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
Adapted from Hauser SL, et al. 2022.11
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
Efficacy outcomes
Efficacy outcomes observed with KESIMPTA® up to 7 years
First choice matters: Early start in active RMS with KESIMPTA® delivers greater effect on ARR vs later switching from teriflunomide (exploratory endpoint)4
ARR in the ALITHIOS extension study (RDTN subgroup)*4
Data from exploratory analyses are descriptive and no confirmatory clinical conclusions can be drawn.
Adapted from Bittner et al. ECTRIMS 2025.4
ARR was defined as the number of confirmed MS relapses per year, according to prespecified criteria.4
* Obtained by fitting a piecewise negative binomial model over the core and extension phases, using a log-link function. The model was adjusted for treatment and region as factors, as well as for the number of relapses in the previous year, and the patient’s age at baseline as covariates. The natural log of the time-in-study (in years), by period, was used as an offset to annualise the relapse rate in each period. Baseline variables refer to those collected at the core study baseline.4
† Continuous group refers to patients randomised to KESIMPTA® in the core study; switch group refers to patients randomised to teriflunomide in the core study and switched to KESIMPTA® during the extension phase.4
9 in 10 patients on KESIMPTA® were observed to have no evidence of disease activity (NEDA-3*) at Year 7†2
NEDA-3* status up to 7 years of KESIMPTA® treatment2 (NEDA-3 was determined in a post-hoc analysis of pooled ASCLEPIOS trials)2
Data from exploratory analyses are descriptive and no confirmatory clinical conclusions can be drawn.
Adapted from Hauser SL et al. ECTRIMS 2025.2
* NEDA-3 was defined as no 6mCDW, no confirmed MS relapse, no new or enlarging T2 lesions and no Gd+ T1 lesions.2
† At Year 7 (ALITHIOS extension study Year 7), 95.0% of patients on continuous KESIMPTA® (N=639) and 93.8% of patients on teriflunomide-KESIMPTA® (N=584) achieved NEDA-3 (1.24; 0.76–2.04, ns).2
Within-group comparisons during the extension phase for ASCLEPIOS and ALITHIOS (RDTN subgroup, N=465)*4
Data from exploratory analyses are descriptive and no confirmatory clinical conclusions can be drawn.
Adapted from Bittner et al. ECTRIMS 2025.4
*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 Gd+ T1 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. All p values are nominal p values.4
77.3% (n=64) of continuous KESIMPTA® patients were observed to be free from 6mCDW for up to 7 years (exploratory endpoint)11
Data from exploratory analyses are descriptive and no confirmatory clinical conclusions can be drawn.
Adapted from Pardo G et al. AAN 2025.11
Differences in 6mCDW between the two groups on KESIMPTA® at Year 7 were not statistically significant (P=0.069; exploratory endpoint).11
83.7% (n=70) of continuous KESIMPTA® patients were observed to be free from 6mPIRA for up to 7 years (exploratory endpoint)11
Data from exploratory analyses are descriptive and no confirmatory clinical conclusions can be drawn.
Adapted from Pardo G et al. AAN 2025.11
Differences in 6mPIRA between continuous and switch groups were not statistically significant in the 7-year analysis (nominal p=0.426; exploratory endpoint)11
Up to 7 Years of KESIMPTA® efficacy data, including RDTN patients†2,4,6
* Efficacy measured as superiority in ARR vs. teriflunomide (ARR defined as the number of confirmed MS relapses per year, according to prespecified criteria).4 All p values are nominal p values.
Safety profile
KESIMPTA® has demonstrated a safety profile generally consistent with its clinical trial programme for up to 8 years, with no new safety signals, increase in malignancies or unexpected adverse events3
The most important and frequently reported adverse reactions with KESIMPTA® are upper respiratory tract infections (39.4%), systemic injection-related reactions (20.6%), injection-site reactions (10.9%) and urinary tract infections (11.9%).1
Learn more about the KESIMPTA® safety profile.
For full prescribing information, including contraindications, warnings and precautions, please refer to the KESIMPTA® Summary of Product Characteristics (SmPC).1
Overall safety profile up to 8 years3
The safety profile of KESIMPTA® remained generally consistent with up to 8 years of treatment in both the overall population and RDTN subgroup.3
| Overall population (N=2,531) | RDTN subgroup (N=546) | ||
AE | n (%) | EAIR (95% CI) | n (%) | EAIR (95% CI) |
Participants with at least one AE | 2,368 (93.6) | 128.46 (123.39–133.74) | 512 (93.8) | 121.65 (111.56–132.66) |
Participants with at least one SAE | 425 (16.8) | 3.94 (3.58–4.33) | 96 (17.6) | 3.67 (3.00–4.48 ) |
AEs leading to KESIMPTA® discontinuation | 167 (6.6) | – | 55 (10.1) | – |
Serious infections | 140 (5.5) | 1.21 (1.03–1.43) | 34 (6.2) | 1.21 (0.86–1.69) |
Serious infections (excluding COVID-19) | 94 (3.7) | 0.80 (0.66–0.98) | 19 (3.4) | 0.66 (0.42–1.04) |
Serious COVID-19 infections | 53 (2.1) | 0.45 (0.34–0.59) | 18 (3.3) | 0.62 (0.39–0.99) |
Injection-related reactions | 819 (32.4) | 9.54 (8.91–10.22) | 142 (26.0) | 6.35 (5.39–7.49) |
Injection-site reactions | 346 (13.7) | 3.28 (2.95–3.64) | 92 (16.8) | 3.65 (2.97–4.47) |
Deaths | 15* (0.59) | – | 8† (1.4) | – |
Malignancies | 40 (1.6) | 0.33 (0.25–0.46) | 11 (2.0) | 0.38 (0.21–0.68) |
Adapted from Pardo et al. AAN 2026.3
The RDTN subgroup refers to patients who were recently diagnosed (≤3 years) and treatment-naïve.3
≥ Overall population (N=2531) included participants receiving ≥1 KESIMPTA® doses in:
– ASCLEPIOS I/II, APOLITOS, APLIOS, ARTIOS, or the umbrella extension study ALITHIOS1–6
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.3
* Including the following: Sudden death (n=1), oesophageal adenocarcinoma (n=1), ventricular fibrillation (n=1), completed suicide (n=1), gastric ulcer perforation (n=1), COVID-19 (n=2), COVID-19 pneumonia (n=1), COVID-19/COVID-19 pneumonia (n=1), COVID-19 pneumonia/pneumothorax (n=1), pneumonia/septic shock (n=1), injury (n=1), intestinal metastasis (n=1), ovarian epithelial cancer (n=1), cerebrovascular disorder (n=1).3
† Sudden death (n=1), oesophageal adenocarcinoma (n=1), ventricular fibrillation (n=1), completed suicide (n=1), COVID-19/COVID-19 pneumonia (n=1), COVID-19 (n=2), aortic dissection (n=1).3
Generally stable mean IgG levels with KESIMPTA® up to 8 years3
The majority of patients maintained IgG and IgM levels above the LLN up to 8 years of treatment. AEs associated with low IgG were reported in 10 patients (0.40%), and due to low IgM in 297 patients (11.7%).3
Observed preserved mean IgG levels up to 8 years (overall population)
Adapted from Pardo G et al. AAN Meeting 2026.3
For all pooled analyses, a fixed LLN value (based on the ALITHIOS study reference) was used: IgG 5.65 g/L and IgM 0.4 g/L. Treatment interruption/discontinuation was reported in 3 (0.1%)/4 (0.2%) patients due to low IgG, and 205 (8.1%)/71 (2.8%) patients due to low IgM.3
* Switching period refers to patients who started on teriflunomide and is not applicable to patients on KESIMPTA® in the core period. For the teriflunomide/KESIMPTA® group, data from the first dose of teriflunomide until the last dose of KESIMPTA® plus 100 days, or the analysis cutoff date has been used.³
† Mean values at Week 384 in the Switch from teriflunomide group should be interpreted with caution due to the very small number of patients at risk.3
Lymphocyte and neutrophil levels remained generally stable for up to 8 years of treatment with KESIMPTA®3
The majority of patients maintained lymphocyte (72.6% in the overall population and 82.0% in the RDTN subgroup) and neutrophil levels (81.5% in the overall population and 83.7% in the RDTN subgroup) above the LLN (0.91 × 109/L and 1.96 × 109/L).3
KESIMPTA®: Up to 8 years of active RMS safety data, including RDTN patients3
Convenience
Convenient, 1-minute-a-month self-administration1,7,8
1 MINUTE A MONTH (after-preparation)*1,2
Once-monthly dosing begins after initial dosing periods at Weeks 0,1 and 2.1
The first subcutaneous injection must be performed under the guidance of a HCP.1
The following are not routinely required with KESIMPTA®:1
Premedication not required
Dose modification not required (renal and hepatic impairment)
No post-loading dose injection monitoring required
Monitoring is required in patients with positive hepatitis B serology.
Patients with active hepatitis B disease should not be treated with KESIMPTA®. Please refer to KESIMPTA® safety profile.
Self-administration at home.†
KESIMPTA® self-administration offers convenience and ease of use‡8,10
In a real-world survey of patients in the US, 89.5% (n/N=94/105) found the KESIMPTA® Pen (Sensoready® Pen) to be easy to use overall.8
* ‘1 minute a month’ refers to the time it takes for a patient to inject a full dose, based on stability data.2,4
Take the pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature.1
Additional time is required to prepare the pen and clean the injection site.1,2
† The flexibility to self-administer without the need for HCP involvement means dosing can occur at home or elsewhere appropriate outside the hospital setting.
‡ KESIMPTA® is intended for patient self-administration by subcutaneous injection with the first injection performed under the guidance of an appropriately trained healthcare professional.1
Nurses (N=50) and patients (N=80) agree:10
Scores: highly rated (>8.0), mid-rated (7.0-8.0), low rated (<7.0)
Easy to perform the self-injection with the KESIMPTA® Pen: nurses vs patients score 9.6 vs 9.3
Patient able to use independently: nurses vs patients score 9.3 vs 9.4
Easy to prepare and set up the KESIMPTA® Pen: nurses vs patients score 9.5 vs 9.3
Patient survey: A cross-sectional survey of adult patients with RMS (N=105) in the US who self-administered KESIMPTA® with the KESIMPTA® pen within the previous 12 months. A total of eight attributes of KESIMPTA® pen were assessed, including ‘administration time’, ‘overall ease of use’, ‘ease of monthly dosing schedule’, ‘time required to device preparation’, ‘ease of device preparation’, ‘device ergonomics’ and ‘portability.8
Nurse and patient survey: multicentre survey including 50 MS nurses and 80 MS patients aimed to investigate their preference for using the KESIMPTA® Sensoready® Pen vs other autoinjector devices. The pilot survey was conducted in Germany, followed by 45-minute, in-field interviews across the US, Germany, France and Italy.10
Convenient, 1-minute-a-month self-administration1,7,8
6mCDW, 6-month confirmed disability worsening; 6mPIRA, 6-month progression independent of relapse activity; AAN, American Academy of Neurology; AE, adverse event; ARR, annualized relapse rate; 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; MET, medium-efficacy treatment; MRI, magnetic resonance imaging; MS, multiple sclerosis; NEDA, no evidence of disease activity; ns, non-significant; OR, odds ratio; PIRA, progression independent of relapse activity; RCTs, randomized controlled trials; RDTN, recently diagnosed treatment naïve; RMS, relapsing multiple sclerosis; SAE, serious adverse event; SC, subcutaneous; SE, standard error
References:
KESIMPTA® Summary of Product Characteristics.
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.
Pardo G et al. Ofatumumab treatment up to 8 years shows a favorable and consistent safety profile in people living with relapsing multiple sclerosis. Poster P9.006 presented at the American Academy of Neurology Meeting 2026, Chicago, IL, USA.
Hauser SL et al. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med 2020;383(6):546-557.
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.
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.
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.
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.
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.
Novartis UK DOF OFA005, September 2022.
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.
UK | FA-11693358 | June 2026
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
