Kesimpta™ (ofatumumab)
Drug Identification Number (DIN): 02511355
Novartis Pharmaceuticals Canada
Kesimpta is a monoclonal antibody that specifically targets CD20, a protein that is found on the surface of white blood cells called B lymphocytes or B cells. Kesimpta is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.
Indications and use
Kesimpta is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.
Administration and dose
Kesimpta is self-injected under the skin once monthly. The first three doses of 20mg are self-injected weekly, then at week 4, switching to 20mg injected once monthly.
Mechanism of action (MOA)
Kesimpta is a monoclonal antibody that binds to CD20 and destroys targeted B cells. B cells are among immune cells that have been implicated in causing damage to the central nervous system in MS.
Side effects*
The most common adverse effects reported for Kesimpta during the clinical trials include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.
Kesimpta may have the potential to cause more serious side effects including hepatitis B virus (HBV) reactivation, and Progressive Multifocal Leukoencephalopathy (PML), a rare brain disease caused by infection by, or re-activation of the John Cunningham virus (JC virus). No cases of PML were reported for Kesimpta in the clinical trials, PML resulting in death has occurred in people treated with ofatumumab for chronic lymphocytic leukemia (CLL) at significantly higher doses than the recommended dose in MS but for a shorter duration of treatment.
This is not a comprehensive list of all possible side effects of Kesimpta. Please see the Kesimpta product monograph for a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Kesimpta.)
Clinical trials
The Health Canada approval of Kesimpta was based on two identical phase 3 studies (ASCLEPIOS I and II) wherein participants were randomly assigned to receive ofatumumab (self-injected once a month), or daily oral teriflunomide for up to 30 months. Kesimpta reduced annual relapses significantly more than teriflunomide, reduced disability worsening at three months, and reduced disease activity on MRI scans.
Cost reimbursement
The price of Kesimpta is approximately $26,000 per year. Much of the cost can be reimbursed through private and group health plans for people who meet the prescribing criteria.
Drug support program
Go Program
Phone: 1-866-841-5518
Fax: 1-866-841-5519
Email: go.program@novartis.com
Hours of Operation: Mon–Fri, 8 a.m. to 8 p.m. EST
References
Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Häring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246. PMID: 32757523.
Kesimpta™ is a trademark of Novartis Pharmaceuticals Canada.