What makes KESIMPTA® (ofatumumab) different?
KESIMPTA is the first and Only SC delivered B-cell treatment for relapsing MS2
The Pen is easy and simple to use.*
Your patients treat themselves at home in just 1 MINUTE A MONTH† when they're ready to administer3-6
*Based on a cross-sectional survey of adult RMS patients (N=105) in the US who self-administered KESIMPTA with the Sensoready Pen within the previous 12 months. A total of 8 attributes of KESIMPTA Pen use were assessed, including “easy and simple to use,” “easy to prepare,” and “convenient/flexible to travel with." 89.5% of patients scored a 4 or 5 on characteristics of overall ease of use and ease of monthly dosing schedule. Questionnaire has not been validated. Initiation of KESIMPTA in patients may be influenced by insurance and availability (among others). Hence, data should be cautiously interpreted.4,5
†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 (ofatumumab).3,6
Right dose. Right frequency. Right route of administration.
The KESIMPTA Phase 2 trial determined that once-monthly frequency in a low SC dose was comparably effective, with fewer side effects, vs higher SC doses. The 20 mg dose was chosen through dose modeling based on B-cell depletion results and Phase 2 data.7,8‡
‡MIRROR was a Phase 2b multicenter, randomized, double-blind, placebo-controlled, dose ranging study of subcutaneous KESIMPTA (N=232). Primary end point was new Gd+ T1 lesions at week 12. Secondary end points included new Gd+ T1 lesions at week 24, and new and/or newly enlarging T2 lesions. Other clinical end points included Expanded Disability Status Scale, Multiple Sclerosis Functional Composite, and Modified Fatigue Impact Scale scores.7
KESIMPTA is delivered in a pre-filled autoinjector pen6§
The Sensoready® Pen can be kept at room temperature (up to 86°F) for up to a week§
No premedication is required prior to treatment‖
No monitoring is required after administration‖
§KESIMPTA Sensoready Pens must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake. If necessary, KESIMPTA may be stored at room temperature below 30°C (86°F) for up to 7 days and returned to the refrigerator, to be used within the next 7 days.6
‖Only limited benefit of premedication with corticosteroids, antihistamines, or acetaminophen was observed in RMS clinical studies. The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If injection-related reactions occur, symptomatic treatment is recommended.6
"The Sensoready® Pen is easy for me and I never see the needle."
Ananda: wife, mom, registered nurse, KESIMPTA patient
Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.
Actual patient taking KESIMPTA who was compensated for time. Individual results may vary.
Based on prescription data collected from April to September 2023.9
What does the SC delivery difference mean for your relapsing MS patients?
KESIMPTA is the only B-cell treatment that is self-administered once monthly—at home or on the go2,6*
A preloaded device, ranked as easy-to-grip with audible and visual cues to help the patient complete administration.6,10†
Persistence was defined as the number of days from the index date until discontinuation or a switch to a new DMT. It was measured during the post index period, which included the index date. Discontinuation was defined as a >60-day gap in therapy (injectables) or >90-day gap (orals) of the index medication, defined as a gap between the last supply date (based on expected duration of treatment or days’ supply) and the next claim date for the index therapy.11,12
*KESIMPTA Sensoready pens must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake. If necessary, KESIMPTA may be stored at room temperature below 30°C (86°F) for up to 7 days and returned to the refrigerator, to be used within the next 7 days.6
†Based on a survey of multiple sclerosis (MS) nurses (N=50) and patients (N=80) in the US, Germany, France, and Italy. Participants were asked to compare attributes of the KESIMPTA Sensoready autoinjector pen with those of other DMT autoinjectors, some of which are not available in the US. The Sensoready Pen was not injected during the survey nor were all devices compared against each other by participants. A total of 17 attributes were assessed, with "easy to perform self-injection with the pen," "ease of preparation and set-up," and "ease of training patient in use" among those most preferred.10
‡Based on a cross-sectional survey of adult RMS patients (N=105) in the US who self-administered KESIMPTA with the Sensoready Pen within the previous 12 months. A total of 8 attributes of KESIMPTA Pen use were assessed, including “easy and simple to use,” “easy to prepare,” and “convenient/flexible to travel with.” 89.5% of patients scored a 4 or 5 on characteristics of overall ease of use and ease of monthly dosing schedule. Questionnaire has not been validated. Initiation of KESIMPTA in patients may be influenced by insurance and availability (among others). Hence, data should be cautiously interpreted.4,5
§Study 1: retrospective cohort study of adult RMS patients treated with KESIMPTA (n=333) vs platform injectables (n=333) (glatiramer acetate, interferon beta-1a/1b, and peginterferon beta-1a).11
Study 2: retrospective cohort study of adult RMS patients treated with KESIMPTA (n=576) or oral DMTs (n=576) (dimethyl fumarate, fingolimod, teriflunomide, cladribine, siponimod, ozanimod, diroximel fumarate, monomethyl fumarate, and ponesimod).12
Both studies were conducted from August 2020 to November 2021, utilizing the IQVIA PharMetrics® Plus database. Patients were indexed on first observed therapy and followed until discontinuation, switch, or 12 months post index for persistent patients. Propensity score matching was used to balance the baseline demographic, clinical, and RMS characteristics, as well as use of prior DMT between cohorts.11,12
Analyses using claims data are dependent on the accuracy and specificity of information provided. Early discontinuation may be overestimated if treatment occurred outside the purview of the claims data source. Caution should be exercised in making any direct comparisons due to differences between DMTs.
IQVIA PharMetrics® Plus is a longitudinal health plan database of medical and pharmacy claims in the United States.
Meet the KESIMPTA Sensoready Pen
See how patients learn to administer KESIMPTA with the Sensoready Pen
Take a different approach to relapsing MS. Make KESIMPTA your 1st choice treatment today!
"KESIMPTA works with my busy schedule. I don't have to rearrange my routine for my treatment."
Kristin: mom, real estate agent, KESIMPTA patient
Actual patient taking KESIMPTA who was compensated for time. Individual results may vary.
How to discuss dosing with your patients6
KESIMPTA dosing schedule
To help patients understand dosing with KESIMPTA, share the instructions below:
Dosing regimen
Initial dosing of 20 mg by subcutaneous injection at weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by subcutaneous injection once monthly starting at week 4. After initial dosing, KESIMPTA is administered once monthly.6
Additional dosing information6
First Dose
The first injection should be performed under the guidance of a health care professional.
Missed Doses
Administer as soon as possible without waiting until the next scheduled dose; subsequent doses should be administered at the recommended intervals.
The use of premedication is not required
Prior to initiating KESIMPTA, perform hepatitis B virus (HBV) screening, test for quantitative serum immunoglobulins, and vaccinate (at least 4 weeks prior for live or live-attenuated vaccines and at least 2 weeks prior for inactivated vaccines)
"The box has an indicator to help keep it at the right temperature during shipping."
Maggie: wife, mom, recent college graduate, KESIMPTA patient
Please see full KESIMPTA package insert for complete instructions for storage and handling.
Actual patient taking KESIMPTA who was compensated for time. Individual results may vary.
Start your patients right away
Life with relapsing MS is complicated enough, starting treatment shouldn't be
Life with relapsing MS is complicated enough, starting treatment shouldn't be
Sample program is only available to patients who are determined to be appropriate candidates for treatment with KESIMPTA.
How KESIMPTA is administered
Your patients can administer KESIMPTA with the Sensoready Pen at home or anywhere with these steps. These are not the complete instructions for using KESIMPTA.6
Please see full Instructions For Use.
How does KESIMPTA administration differ from other B-cell therapies?
This chart is only intended to show administration times. No conclusions of comparative efficacy and safety should be drawn. KESIMPTA is administered in 1 minute a month subcutaneously. Ocrevus and Briumvi are administered twice yearly via infusion. Please refer to the product’s specific prescribing information for complete dosing and administration instructions.
*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.3,6
DMT, disease-modifying therapy; Gd+, gadolinium-enhancing; Ig, immunoglobulin; MOA, mechanism of action; MS, multiple sclerosis; RMS, relapsing multiple sclerosis; SC, subcutaneous.