What is Kesimpta?
Kesimpta (ofatumumab) is a prescription (injection) medication used to treat multiple sclerosis (MS). It is a self-injected monoclonal antibody that helps reduce immune system attacks on the nervous system.
Efficacy And Statistics Of Kesimpta
- Annualized Relapse Rate (ARR): Kesimpta reduced the ARR by about 50% compared to teriflunomide (Aubagio) in the ASCLEPIOS I and II Phase 3 trials.
- MRI Lesions: Patients treated with Kesimpta experienced a 96.4% reduction in gadolinium-enhancing T1 lesions and an 82.7% reduction in new or enlarging T2 lesions over six years compared to those who switched from teriflunomide.
- Disability Progression: Continuous treatment with Kesimpta for up to six years resulted in 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening events compared to patients who switched from teriflunomide.
- Long-Term Outcomes: More than 80% of patients receiving continuous Kesimpta treatment showed no worsening of disability over a five-year period.
- Confirmed Disability Progression (CDP): Continuous Kesimpta treatment for up to six years resulted in a 30% risk reduction in six-month CDP compared to patients who switched from teriflunomide to Kesimpta later.
- No Evidence of Disease Activity (NEDA-3): A significant proportion of patients achieved NEDA-3 status (indicating no relapses) no MRI activity and no disability progression over a five-year period.
- Safety Profile: Kesimpta has demonstrated a favorable safety profile over long-term use. Injection-related reactions were mostly mild to moderate and no life-threatening reactions reported. Besides that immunoglobulin levels remained stable and no association between decreased immunoglobulin levels and serious infections was observed.
What Are The Side Effects Of Kesimpta?
Common Side Effects Of Kesimpta:
- Upper Respiratory Tract Infections: Thesecould be seen in more than 10% of patients. Symptoms may include sore throat, runny nose and headache.
- Injection-Related Reactions: About 20% of patients experience these reactions within 24 hours after administration. Symptoms could be; fever, headache, muscle pain, chills and fatigue. 99.8% of these reactions are mild to moderate in severity.
- Injection Site Reactions: These local reactions like as; redness, pain, itching and swelling at the injection site could be seen in more than 10% of patients.
- Headache: Reported in more than 10% of patients.
- Urinary Tract Infections (UTIs): These happen in more than 10% of patients. Symptoms are; strong persistent urge to urinate, burning sensation during urination and cloudy urine.
Less Common Side Effects Of Kesimpta:
- Back Pain: Reported in 1% to 10% of patients.
- Oral Herpes: Reported in 1% to 10% of patients.
Serious Side Effects Of Kesimpta:
- Infections: Kesimpta can increase the risk of serious infections such as; bacterial, fungal and new or reactivated viral infections. Some of these infections have been fatal in patients treated with other CD20 antibodies.
- Hepatitis B Virus (HBV) Reactivation: Kesimpta may lead to HBV reactivation in patients who are chronic carriers. This can cause to serious liver problems like liver failure or death. Patients should be screened for HBV before starting treatment.
- Progressive Multifocal Leukoencephalopathy (PML): PML is a serious brain infection that has been associated with Kesimpta but rare. Symptoms; vision problems, loss of coordination and memory difficulties. Immediate medical attention is necessary if PML is suspected.
- Low Immunoglobulin Levels: Kesimpta can lead to decrease in immunoglobulin levels and can increase the risk of infections. Monitoring of immunoglobulin levels is recommended during treatment.
You can find details about another common and effective MS drugs Gilenya in below:
What Are The Costs Of Kesimpta?
Cost Of Kesimpta in the United States
- List Price Of Kesimpta: The list price for Kesimpta is about $8,736 per treatment.
- Annual Cost Of Kesimpta: Given that the treatment involves multiple doses throughout the year, the annual cost can be significant and change according to doses number.
- Patient Assistance: KESIMPTA Patient Support Program offers an Access Card that can reduce out-of-pocket costs to $0 for eligible patients. Specifically; 97% of all prescriptions filled have a $0 out-of-pocket cost when used with the Access Card. Program provides up to $18,000 in annual copay benefits for patients with commercial insurance who have coverage for Kesimpta.
Cost Of Kesimpta in the Europe:
- Per Dose Cost Of Kesimpta: Single dose of Kesimpta (20 mg/0.4 mL) costs around €1,700 in Europe.
- Annual Cost Of Kesimpta: Kesimpta injections are administered once a month. This results in an estimated annual cost of about €25,500 in the first year and about €20,400 in subsequent years.
What Are The Dosages Of Kesimpta?
Recommended dosage regimen consists of an initial loading phase followed by a monthly maintenance phase.
Standard Dosage Schedule
- Initial Loading Doses:
- Week 0: 20 mg (one injection)
- Week 1: 20 mg (one injection)
- Week 2: 20 mg (one injection)
- Maintenance Dose:
- Starting at Week 4: 20 mg once per month
Administration Details
- Kesimpta is injected subcutaneously (under the skin) in the abdomen, thigh or upper arm.
- The first dose may be administered by a healthcare worker but subsequent doses can be self-administered at home.
- Patients should rotate injection sites to avoid irritation.
Special Considerations
- Missed Dose Of Kesimpta: If a dose is missed, it should be taken as soon as possible and the regular schedule should be continued.
- Hepatitis B Screening: Patients should be screened for Hepatitis B Virus (HBV) before starting Kesimpta.
- Immunoglobulin Monitoring: Kesimpta may lower immunoglobulin (Ig) levels over time and requiring periodic monitoring.
Advices For Kesimpta Users
1. Follow the Dosage Schedule
- Initial loading phase: Be sure about following the prescribed schedule for the first three doses (week 0, week 1 and week 2) and then switch to the monthly maintenance dose starting at week 4.
- Consistency is key: Stick to the once-a-month injection schedule to maintain effectiveness.
2. Be Aware of Side Effects
- Injection-related reactions: Some people may experience fever, headache, chills or fatigue after the injection. Especially in the first few doses. These reactions are usually mild to moderate and go away after a short time.
- Infections: Be aware of any signs of infection such as; fever, sore throat, cough or pain during urination because of Kesimpta can weaken your immune system.
- Serious side effects: Seek immediate medical attention if you experience any symptoms of severe infections; progressive multifocal leukoencephalopathy (PML) or if you notice unexplained changes in vision, memory issues or difficulty with coordination.
3. Monitoring and Tests
- Hepatitis B: Be sure you are screened for Hepatitis B before starting treatment. Reactivation of Hepatitis B can be a risk and it’s important to fallow your liver function throughout treatment.
- Immunoglobulin levels: Kesimpta may lower immunoglobulin levels so periodic testing is recommended to monitor your immune system’s ability to fight infections.
- Neurological evaluations: Keep regular appointments with your doctor to track any potential neurological changes or signs of MS progression.
4. Injection Technique
- Self-injection training: Make sure you’re properly trained to inject Kesimpta at home.
- Rotate injection sites: Alternate between different areas like your abdomen, thigh and upper arm to avoid irritation at the injection site.
- Proper storage: Keep your Kesimpta injections in the refrigerator (between 2°C to 8°C / 36°F to 46°F) until you’re ready to use them. Don’t freeze the medication.
5. Stay in Contact with Your Doctor
- If you experience any side effects or have concerns discuss them with your doctors. They can adjust your treatment plan if needed.
- If you’re planning on traveling or if your schedule changes discuss how to manage your monthly injections.
6. Healthy Lifestyle
- Stay active: Regular exercise can help maintain health and may also help manage MS symptoms.
- Eat a balanced diet: Healthy diet is important for your immune system and well-being.
- Stay hydrated and get enough rest.
We wish you a healthy and happy life. Also you can find a detailed comparison of most common MS treatment drugs in below:
