How does KESIMPTA work?
The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.1
In which types of patients with RMS is KESIMPTA appropriate?
KESIMPTA is indicated for the treatment of adult patients with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
KESIMPTA was studied in a broad range of patients in two Phase 3 clinical trials.
- Approximately 40% of patients in KESIMPTA clinical studies were DMT-treatment naïve
- The study population included patients 18-55 years of age with an EDSS score of 0 to 5.5.1,4
What is CDP?
A key clinical outcome measured in the pivotal studies was confirmed disability progression (CDP). Disability progression was defined as an increase in EDSS of at least 1.5, 1, or 0.5 points in patients with a baseline EDSS of 0, 1 to 5, or 5.5 or greater, respectively.
Can I provide samples to any patient?
Samples can be provided to any KESIMPTA patient, but consider your patients’ access scenario:
- Commercially insured patients start treatment immediately with the KESIMPTA Access Card—they’ll avoid insurance delays and get a $0 copay. Remind them to use the samples provided for initial dosing and the medication they receive in the mail for their monthly dosing
- Alongside™ KESIMPTA will work to secure coverage prior to dispensing paid product to government-insured or uninsured patients so they can get started as quickly as possible
What injection training support does Novartis offer?
As the first injection of KESIMPTA should be performed under the guidance of a health care professional, it is up to the discretion of the HCP to determine how to monitor their patients.1
Alongside KESIMPTA offers supplemental resources and flexible assistance to patients on how to administer KESIMPTA—fitting into their needs via:
- Quick Tips for Use brochure (sent to patient’s home with Welcome Package)
- On-demand training videos at KESIMPTA.com
- Virtual injection training (eg, video chat) by nurses
- In-home injection training by nurses
How can I order in-home supplemental training?
Simply check the "supplemental injection demonstration" box on the Start Form.
Were there any cases of hepatitis B observed with KESIMPTA?
No cases of hepatitis B virus (HBV) reactivation were identified in KESIMPTA clinical studies. Hepatitis B reactivation has occurred in patients treated with anti-CD20 antibodies, which in some cases resulted in fulminant hepatitis, hepatic failure, and death. Patients with active hepatitis B disease should not be treated with KESIMPTA. All patients should be screened for hepatitis B before starting KESIMPTA.
What COVID-19 safety protocols are in place for in-home injection training?
Twenty-four hours prior to the scheduled appointment, in-home nurses will call the patient to confirm the appointment, and will run through several COVID-19 screening questions:
- Do you have a fever?
- Do you have a cough or shortness of breath?
- Does anyone in your household have a fever, cough, or shortness of breath?
- In the past 2 weeks, have you been exposed to anyone who has COVID-19?
If the patient answers “Yes” to any of these questions, the appointment will be rescheduled. Nurses will also self-assess with the above questions; if the nurse answers “Yes” to any of the above questions, the appointment will be rescheduled, and the patient may be assigned to a different nurse. All nurses will be equipped with the following PPE for any in-home appointments:
- Alcohol wipes
- Face masks
- Face shields
- Shoe covers