Simponi (golimumab) is a TNF-alpha blocker biologic medication used to treat autoimmune conditions such as ankylosing spondylitis, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis. Golimumab (Simponi) is a fully human monoclonal antibody that helps control inflammation and prevent joint damage. Golimumab has been marketed as Simponi and Simponi Aria. Simponi is administered subcutaneously using an auto-injector, generally one injection every four weeks. Simponi is approved for treating ankylosing spondylitis, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis.
Simponi Aria is an intravenous infusion administered by a healthcare professional. It is typically given every eight weeks after two initial doses at week 0 and week 4. It has been FDA-approved for treating ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. Simponi Aria infusion is not approved for ulcerative colitis.
Simponi Uses and Dosages
The physician decides the frequency and dosage of Simponi after assessing the disease condition, body weight, and how the disease responds to the treatment. Golimumab is used to treat the following conditions:
Ankylosing Spondylitis
Simponi reduces inflammation, alleviates pain, improves mobility, and eases stiffness in patients with active ankylosing spondylitis. It improves the overall quality of life to participate in daily tasks and physical activities. Simponi (golimumab) has rapid action, with many patients reporting symptom relief within weeks.
Simponi subcutaneous injection is typically prescribed as a 50 mg dose every four weeks for treating moderate to severe ankylosing spondylitis. Simponi Aria is generally prescribed a 2mg/kg IV infusion over 30 minutes at week 0 and week 4, followed by a 2mg/kg maintenance dose every 8th week.
Ulcerative Colitis
Simponi is indicated for patients with moderate to severe ulcerative colitis who are not responding to conventional therapies. It can help reduce inflammation and ease symptoms such as abdominal pain, diarrhea, and rectal bleeding. It can also promote gut healing and restore normal gastrointestinal function.
Simponi is typically prescribed as a 200 mg subcutaneous dose at week 0, a 100 mg dose at week 2, and a maintenance dose of 100 mg every 4 weeks. The physician will assess the disease condition and devise the dosage plan accordingly.
Psoriatic Arthritis
Simponi targets autoimmune inflammation in psoriatic arthritis and alleviates symptoms such as joint swelling, stiffness, pain, and tenderness. It also effectively manages inflammation of tendons and ligaments and “sausage joints” associated with psoriatic arthritis.
Simponi can help with chronic fatigue by effectively controlling systemic inflammation. It can also improve skin symptoms such as psoriatic plaques and scaling. Simponi is typically prescribed as a 50 mg subcutaneous dose once a month for moderate to severe psoriatic arthritis in adults. A physician will assess the disease condition and may suggest combination therapy with methotrexate.
Simponi Aria is prescribed as a 2 mg/kg intravenous infusion for over 30 minutes for moderate to severe psoriatic arthritis in adults at week 0 and week 4, followed by a 2mg/kg maintenance dose every 8th week. Simponi can improve symptoms within 2 to 4 weeks, with significant improvement after 8 – 12 weeks, depending on the disease severity and responsiveness to the treatment.
Rheumatoid Arthritis
By controlling inflammation, Simponi eases joint pain, swelling, and morning stiffness. It can also slow disease progression, reduce joint erosion and deformation, and improve mobility. Simponi alleviates systemic inflammation and helps manage chronic fatigue associated with rheumatoid arthritis.
Simponi is typically prescribed as a 50 mg subcutaneous dose once a month for adults with active rheumatoid arthritis. A physician will assess the disease condition and may suggest combination therapy with methotrexate or other anti-inflammatory medicines.
Simponi Aria is administered 2mg/kg intravenous infusion over 30 minutes at week 0 and week 4, followed by 2mg/kg maintenance doses every 8 weeks. The physician may suggest combination therapy with methotrexate.
Polyarticular Juvenile Idiopathic Arthritis
Simponi Aria effectively manages joint pain, swelling, and stiffness in children aged 2 or above with polyarticular juvenile idiopathic arthritis. It is administered as a 2 mg/kg intravenous infusion for over 30 minutes at week 0 and week 4, followed by 2mg/kg maintenance doses every 8th week.
Risks and Side Effects
Patients with existing heart conditions should discuss with a healthcare professional before using Simponi as TNF-alpha blockers can worsen some heart conditions. A preliminary screening is recommended before starting Simponi to prevent the reactivation of latent infections such as tuberculosis and hepatitis B. A latent infection happens when bacteria or viruses enter the body but do not cause symptoms right away. They have the potential to reactivate and cause infections under a weakened immune system.
Live vaccines should not be administered while on Simponi medication. Consult your physician if you plan to receive any vaccines. Like all biologics, Simponi may come with the following side effects:
- Mild allergic reaction
- Headache
- Upper respiratory tract infections
- Itching or swelling at the injection site
Serious but less common risks and side effects may include:
- Severe allergic reaction
- Serious infections such as vaginal and urinary tract infections. Simponi suppresses the immune system, which can also reactivate latent infections (e.g., tuberculosis and hepatitis B)
- Increased risk of certain cancers (e.g., skin cancer)
Benefits of Simponi
All TNF-alpha blocker biologic medications work similarly to reduce inflammation. However, different biologic medications have different efficacy for TNF-alpha, and suitability may vary depending on the disease. Always consult a healthcare professional when choosing a TNF-blocker.
Some patient-centered advantages of Simponi are:
- Simponi is offered as a pre-filled autoinjector that is easy to administer.
- Simponi Aria has rapid action due to intravenous infusion
- Simponi has a convenient dosing schedule: once a month for subcutaneous dose and once every 8th week for intravenous infusion. Humira and Enbrel require weekly administration.
- Simponi has a consistent efficacy profile with better tolerability.
Cost of Simponi
In the United States, Simponi costs $6000 to $8000 per month for a subcutaneous autoinjector. The cost may vary depending on pharmacy and insurance coverage. Janssen Biotech also offers cost support for Simponi.
The cost is generally lower in European countries, ranging from $3000 to $6000 per month due to government negotiations. Biosimilar to Simponi, AVT05 is currently under development and may offer significant cost savings when launched.
Conclusion
Simponi effectively manages the selected autoimmune conditions by reducing systemic inflammation by blocking TNF-alpha. It is convenient to use and has a rapid onset of action when used intravenously.
Consult a healthcare provider for personalized advice to see if Simponi is suitable for your condition.
