Golimumab is a prescription biologic medication used to manage specific autoimmune disorders. It is a man-made protein designed to target a particular part of the immune system that contributes to inflammation. Available under brand names like Simponi and Simponi Aria, this therapy is not a first-line treatment and is often considered when other medicines have not worked sufficiently.
Conditions Treated by Golimumab
Golimumab is approved to treat several autoimmune conditions characterized by chronic inflammation. One of the primary uses is for moderate to severe rheumatoid arthritis, a disease where the immune system primarily attacks the joints, causing pain, swelling, and potential destruction. It is often used in combination with another medication, methotrexate, for this condition.
Another application is for psoriatic arthritis, which involves both the joint inflammation seen in arthritis and the scaly skin patches associated with psoriasis. It can be used alone or with methotrexate for this condition. It is also prescribed for ankylosing spondylitis, a type of arthritis that mainly affects the spine, leading to pain and stiffness. Finally, it is used for moderate to severe ulcerative colitis, an inflammatory bowel disease that affects the large intestine.
Mechanism of Action
Golimumab is a type of synthetic protein known as a monoclonal antibody. This antibody is specifically engineered to identify and bind to a protein in the body called Tumor Necrosis Factor-alpha, or TNF-alpha.
In many autoimmune diseases, the body produces an excess of TNF-alpha. This protein acts as a messenger, signaling immune cells to create inflammation. While inflammation is a normal process for fighting infection and healing injuries, its overproduction in these conditions leads to a persistent attack on the body’s own tissues, such as the joints or digestive tract.
Golimumab works by intercepting these TNF-alpha messenger proteins before they can deliver their inflammatory signals. By binding to and neutralizing TNF-alpha, the drug prevents it from activating the inflammatory cascade. This action helps decrease disease symptoms like pain and swelling and can slow the progression of joint damage.
Administration and Dosing
Golimumab is delivered in two ways, depending on the product. The first method, associated with the brand name Simponi, is a subcutaneous injection. This involves injecting the medication just under the skin, a procedure that patients can be trained to do themselves at home. These injections are administered on a monthly basis.
The second method is an intravenous (IV) infusion, marketed as Simponi Aria. This procedure is performed in a clinical setting by a healthcare professional. The medication is delivered directly into a vein, and the process takes more time than an injection. Following an initial loading dose schedule, these infusions are given every eight weeks. The exact dosage and frequency for either method are determined by a physician based on the specific condition being treated and the patient’s weight.
Potential Side Effects and Safety Information
Treatment with golimumab carries a risk of side effects. Common reactions include:
- Redness, swelling, pain, or itching at the injection site
- Upper respiratory infections, such as a runny nose or sore throat
- Viral infections like the flu
- Abnormal liver function tests
- High blood pressure
A primary safety concern is its potential to suppress the immune system, increasing the risk of serious infections. The U.S. Food and Drug Administration has issued a black box warning for this drug regarding this risk. Patients may become more susceptible to infections, including tuberculosis (TB), as well as bacterial, fungal, and viral infections that can be severe or even fatal. Before starting treatment, patients must be tested for TB, and those with a history of chronic or recurrent infections require careful evaluation.
There is also a noted risk of certain types of cancer. Some users, including children and young adults, have developed lymphomas and other malignancies from TNF-blocking drugs like golimumab. A rare and aggressive type of cancer called hepatosplenic T-cell lymphoma has been seen in some younger patients treated for ulcerative colitis or Crohn’s disease. Patients should immediately report symptoms like swollen lymph nodes, unusual bruising, or unexplained weight loss to their doctor.
Other serious potential side effects include the worsening or new onset of heart failure, and individuals may experience shortness of breath or swelling. The medication can also lead to nervous system disorders, such as multiple sclerosis, or cause a lupus-like syndrome characterized by a sun-sensitive rash and joint pain. Patients should discuss their complete medical history with their healthcare provider to weigh the benefits and risks of starting golimumab.