Your Guide to Kesimpta for Multiple Sclerosis

Overview of Kesimpta

Kesimpta (ofatumumab) is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). It was approved in August 2020 by the U.S. Food and Drug Administration (FDA).

MS is a long-lasting (chronic) condition affecting the brain and spinal cord (central nervous system). In MS, the immune system mistakenly attacks the protective covering, called the myelin sheath, around axons of nerve cells in the central nervous system, disrupting communication between the brain, spinal cord, and the rest of the body.

This condition causes a range of symptoms, including: vision problems; muscle weakness and muscle stiffness accompanied by painful muscle spasms; tingling, numbness, or pain in the arms, legs, trunk, or face; clumsiness, especially difficulty staying balanced when walking; bladder control problems; and intermittent or constant dizziness.

Many individuals with MS experience periods of worsening symptoms (relapses) followed by periods of recovery (remissions). This form of MS is called relapsing-remitting MS. Over time, recovery may be incomplete, resulting in increased disability.

Around 2.8 million people worldwide have MS, according to the most comprehensive international study to date. Genetic predisposition, certain viral infections and environmental factors like low sunlight exposure increase the likelihood of getting MS, say the experts at the National Institute of Neurological Disorders and Stroke.

While it is not fully understood how Kesimpta works, it is designed to target specific immune cells believed to play a role in relapsing MS.

Kesimpta is a prescription medicine used to treat adults with relapsing forms of MS including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease. It is not known if Kesimpta is safe and effective in children.

Normally, B-cells that form part of the immune system help the body to fight off infection. In relapsing MS, B-cells located in the lymph nodes mistakenly attack the protective covering (myelin sheath) around the nerve cell axons in the brain and spinal cord.

Although the exact way Kesimpta works is not fully known, it is designed to target the B-cells, deplete them, and stops them from attacking and damaging myelin around nerve cells.

Kesimpta is available in the form of prefilled auto-injector pens (Sensoready® pen) and prefilled syringes, which are for one-time use only and should be discarded after use.

When you start Kesimpta, you self-inject one dose of 20 mg/0.4 mL per week for the first three weeks. These are the starter doses. After the third dose, you’ll skip a week. On the fifth week, inject the first maintenance dose. After that, continue taking Kesimpta once a month.

Kesimpta is typically administered as a subcutaneous injection (under the skin) in the abdomen, thigh or outer upper arm. The injection should not be given into moles, scars, stretch marks or areas where the skin is tender, bruised, red, scaly or hard.

The first injection of Kesimpta should be performed under the guidance of a health care professional. After that, you can perform the injections alone at home.

The FDA approved Kesimpta based on evidence from two clinical trials published in the New England Journal of Medicine. The two studies recruited a total of 1,882 participants, who received either Kesimpta or another MS drug (Aubagio, teriflunomide). Patients with relapsing MS were randomized to receive subcutaneous ofatumumab (20 mg every 4 weeks, after 20-mg loading doses at days 1, 7, and 14) or oral teriflunomide (14 mg daily) for up to 30 months. In both studies, compared to patients receiving Aubagio, those receiving Kesimpta had reduced annualized relapses, fewer active lesions (gadolinium-enhancingT1 lesions), fewer new or enlarging lesions and slowed disability progression.

In these two studies, Kesimpta showed a similar safety profile to Aubagio, with the frequency of serious infections and cancer (malignancies) also being similar across both treatment groups. The most common side effects of Kesimpta were injection-related reactions, inflammation of the nasal passages and throat (nasopharyngitis), headache, injection site reactions, upper respiratory tract infection, and urinary tract infection.

After these two clinical trials with Kesimpta, the safety and tolerability of the drug continued to be studied in the long term in relapsing MS. Results published in Multiple Sclerosis Journal show that long-term treatment with Kesimpta has a favorable benefit-risk profile in RMS through four years of treatment.

Based on evidence from clinical trials, the FDA deemed the benefits of Kesimpta to outweigh the risks for people with multiple sclerosis. However, side effects may occur, some of them serious.

Common side effects include:

• Local injection-site reactions, with symptoms like redness, pain, itching and swelling around the area of the injection

• Injection-related side reactions, with symptoms like fever, headache, muscle pain, chills and fatigue

• Upper respiratory infections, with symptoms like sore throat, runny nose and headache

• Headache

Some potential serious side effects are:

• Infections resulting from a weakened immune system. Tell your health care provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment with Kesimpta.

• Hepatitis B virus reactivation: If you’ve ever had a Hepatitis B virus infection, it may become active again during or after treatment with Kesimpta.

• Progressive multifocal leukoencephalopathy (PML): This is a rare, serious brain infection caused by a virus that may get worse over days or weeks, and can result in death or severe disability.

• Low immunoglobulins: Kesimpta may decrease some types of antibodies. Your doctor will do blood tests to check your immunoglobulin levels.