FDA Approves Simponi for Ulcerative Colitis, Is It For You?
If you suffer with ulcerative colitis, the fact that the Food and Drug Administration (FDA) just approved golimumab (SImponi) for treatment of moderate to severe cases of the disease may be good news. At the same time, you need to learn what you can about Simponi, consider other treatment options, and then along with your healthcare provider, decide if it is for you.
What is Simponi?
Simponi is in a drug class known as tumor necrosis factor (TNF) inhibitors, which means it has the ability to inhibit the activity of TNF, a substance that promotes inflammation and is the cause of many symptoms associated with ulcerative colitis and other autoimmune inflammatory conditions. In fact, Simponi was previously approved by the FDA to treat diseases in this category, including ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis.
Now the FDA has approved Simponi for patients with ulcerative colitis who have not responded to other approved treatments or who need continuous treatment with steroids to manage their disease symptoms. Those symptoms can include the following, depending on the severity of the disease: rectal pain, feeling of urgency, rectal bleeding, abdominal pain, bloody diarrhea, weight loss, and fatigue.
Ulcerative colitis is an inflammatory condition that affects the innermost lining of the large intestine and rectum. Symptoms typically develop over time and are chronic, and currently there is no cure.
New Simponi studies
The results of two clinical trials convinced the FDA to approve Simponi for ulcerative colitis. In both trials, which included more than 800 patients, patients who took Simponi were more likely to experience symptom relief, achieve clinical remission, and show improvement in the intestinal tract with endoscopic evaluation than patients who took placebo.
Although Simponi has been shown to help reduce symptoms of moderate to severe ulcerative colitis, the drug is associated with significant side effects. One major side effect of Simponi is an increased risk of serious, life-threatening infections from bacteria, viruses, fungi, parasites, and other pathogens, especially Legionella and Listeria.
Other side effects associated with Simponi use include heart failure, allergic reactions, development of skin cancer, neurological disorders, lymphoma, and reactivation of hepatitis B. The investigators noted that the most common side effects were upper respiratory infections and redness at the drug injection site, as the medication is administered under the skin.
Other treatments for ulcerative colitis
Among the conventional treatments for ulcerative colitis are corticosteroids, sulfasalazine, mesalamine (e.g., Apriso, Dipentum), and drugs in the same class as Simponi, including adalimumab (Humira) and infliximab (Remicade). However, because all of these drugs are associated with significant side effects, you may want to consider some alternatives.
Natural treatments for ulcerative colitis include the good bacteria known as probiotics, olive oil extract, and vitamin D. A more controversial treatment option is marijuana, which has demonstrated an ability to relieve pain and depression and improve the ability to work.
Ulcerative colitis is a challenging disease to treat. Simponi is the latest addition to the drug options, yet patients with ulcerative colitis should be aware of the side effects and also of nondrug alternatives for relief.