Key takeaways
Remicade is a powerful intravenous immune suppressant prescribed to control moderate to severe forms of ulcerative colitis, an inflammatory bowel disease.
This drug, as well as others in the biologics class, carries a significant risk of serious infections and cancer.
Alternative options for ulcerative colitis treatment exist, many without Remicade’s side effects and that don’t require infusions.
Frequent bloody diarrhea is one of the hallmark symptoms of ulcerative colitis, an inflammatory disease of the colon or large intestine. When disease symptoms escalate to a moderate or severe degree, healthcare providers may prescribe strong medications to douse the flames of inflammation. One such drug is Remicade (infliximab), a monoclonal antibody that blocks the biochemical cascade that fuels this autoimmune disease. As an intravenous infusion given to both halt flare-ups and maintain disease remission, Remicade has powerful potential but also very real risks.
The role of Remicade for ulcerative colitis
Infliximab is an antibody that intercepts one of the key messengers of the immune system’s signaling pathway. It blocks tumor necrosis factor-alpha (TNF-alpha), which can cause inflammation. Ulcerative colitis (UC) is marked by high levels of TNF-alpha in the intestinal wall, where it stokes more inflammation. Remicade can put a stop to it.
Like many diseases, including the other well-known inflammatory bowel disease, Crohn’s disease, UC has varying severities. Mild UC is typified by fewer than four bloody stools per day and no systemic symptoms, like anemia, weight loss, or elevated inflammatory markers (measured with blood tests). When the disease is more severe, bloody diarrhea intensifies, and anemia and abdominal pain may occur. At worst, these elements can be more profound, causing weight loss, fever, or tachycardia (a heart rate above 100 beats per minute). Healthcare providers call upon Remicade for patient care if they fall into the moderate to severe categories.
Benefits of Remicade for ulcerative colitis
Stopping the daily impact of frequent diarrhea and pain is a welcome benefit of Remicade. At another level, UC control boosts one’s overall health. With the immune system not using resources to fight a war on its own body, our systems can devote more proteins and energy to daily living. A meta-analysis of clinical studies has demonstrated the drug’s effectiveness in inducing remission from a UC flare.
As an intravenous (IV) infusion, Remicade requires a healthcare professional to place an IV catheter and administer the medication in a medical clinic. Some people like the fact that Remicade isn’t a self-injection. But on the flip side, it may be inconvenient to go to a clinic or infusion center to get Remicade infusions on a regular basis.
RELATED: Remicade infusions: What to expect
Remicade dosages for ulcerative colitis
Dosages of Remicade are established for the induction and maintenance of disease remission. It is weight-based, and the dose can be increased if needed to maintain control. Alternatively, the interval between doses can be adjusted, becoming more frequent if needed. Here’s the typical Remicade dosing schedule:
- Induction dose: 5 mg/kg of body weight intravenously and repeated to and six weeks from the initial dose
- Maintenance dose: 5 mg/kg of body weight intravenously every eight weeks
- Maximum dose: 10 mg/kg of body weight intravenously every four weeks
You can anticipate a response to Remicade within weeks but may have some relief within days. It is your symptoms that help to guide decision-making about whether to increase the dose or not. In addition, inflammatory markers and drug levels can be monitored with blood tests, providing more feedback to the treating healthcare provider. Gastroenterologists are generally the specialists who have the ultimate responsibility for UC treatment.
It is worth noting that subcutaneous infliximab injections can be an option for maintenance treatment of ulcerative colitis. The subcutaneous infliximab product is called Zymfentra and can be administered easily with a pen injector device.
Remicade side effects & warnings
Remicade has a host of side effects patients should be aware of so they are well-informed to inform their healthcare provider as soon as possible.
Common side effects of Remicade include:
- Mild infusion reactions
- Nausea or abdominal pain
- Headache
- Rash or itching
- Joint pain
- Fever
- Fatigue
Adverse effects of Remicade can be much more severe, though—severe enough for the Food and Drug Administration (FDA) to issue multiple boxed warnings about the drug and its TNF-alpha blocker brethren. Because the drug suppresses the immune system, the FDA warns specifically about the risk of serious infections, such as tuberculosis and fungal infections. A warning about cancer risk was also highlighted, based on lymphoma cases in children.
Other serious side effects of Remicade include:
- Hepatitis B reactivation
- Anaphylactic allergic reactions
- Severe infusion reactions
- Severe skin rashes, such as Stevens-Johnson syndrome
- Congestive heart failure
- Liver toxicity
- Lung disease
- Autoimmune disease
- Heart attack or stroke
Because of its effect on the immune system, Remicade may cause problems when mixed with other therapeutics. Live virus vaccines must be avoided when using infliximab for fear of infection, and inactive vaccines may not be as effective. Some other immunosuppressants can be used carefully alongside Remicade if needed to control UC, but doing so may increase the risks of infection.
Who should not take Remicade for ulcerative colitis?
Anyone with a history of serious allergic reactions to Remicade should not take it again. Depending on the dose used, moderate to severe congestive heart failure may be a contraindication as well.
Even if those contraindications do not apply, a patient’s pretreatment evaluation may detect a reason to hold off on Remicade. Testing for latent infections with tuberculosis, hepatitis C, and hepatitis B is typical; any of these may require treatment first before getting on an immunosuppressant. A healthcare provider may also ensure their patients are immune to varicella, the virus that causes chickenpox and shingles.
Maternal use of Remicade during pregnancy or breastfeeding may be continued after weighing the benefits of UC control versus the possible risks on an individual basis and getting expert medical advice. In some cases, it may be worth reducing the dose in the third trimester or scheduling the last Remicade dose further away from the estimated delivery date. After exposure during pregnancy, infants can be considered immunosuppressed temporarily after birth due to lingering infliximab. Live vaccines are typically withheld in early infancy after exposure, according to the drug’s labeling, but fortunately, most infant vaccines are not live versions.
Remicade vs. other treatments for ulcerative colitis
Remicade is not your only option for UC treatment. Other TNF-alpha blockers, specifically Humira (adalimumab) and Simponi (golimumab), are alternatives. They can be given by subcutaneous injection, so they can be self-administered at home. There have not been comparison studies showing the superiority of any of these, so the choice of which to use may come down to cost and convenience, aside from the prescriber’s recommendation.
Infliximab is such a complex molecule that when patent expiration allowed generic versions to be made and sold, competing companies aimed for an extremely similar molecule that had the same actions. These biosimilars effectively are the generic versions of Remicade, although slight molecular differences in structure exist. Most importantly, they have shown their similar action and can be more affordable.
Anti-TNF alpha agents are only one variety of biologics for UC. Entyvio (vedolizumab) blocks integrin, a different link in the chain of immune system signaling. It is more specific to the intestine, meaning it may not suppress other actions of the immune system as much. Interleukin is another immune system protein that can be inhibited. Stelara (ustekinumab) and Omvoh (mirikizumab) have this action. Choosing between these biologics and a TNF-alpha blocker may come down to what other autoimmune diseases, such as rheumatoid arthritis or psoriatic arthritis, are present and whether additional risk factors for infection exist.
Oral medications are other options for UC treatment. The so-called small molecule medications include Xeljanz (tofacitinib), Rinvoq (upadacitinib), Zeposia (ozanimod), and Velsipity (etrasimod). Oral glucocorticoids, like prednisone, can be used to treat UC as well, and their IV versions can be substituted in some situations.
Remember that more options than these exist for treating milder forms of UC. Remicade and its alternatives are aimed at moderate to severe cases. TNF-alpha blockers and biologics, in general, can be classified under the umbrella drug category called antirheumatics.
How much does Remicade cost?
Remicade’s disease-modifying and life-changing capability can be appealing despite its serious risks. The drug’s price can be another deterrent, unfortunately. Depending on the dose, a single Remicade infusion can cost between $4,000 and $7,000. If this becomes a barrier to treatment, you can ask your healthcare provider about a lower-cost biosimilar to Remicade. You may even be able to lower the cost of more affordable biosimilars with a SingleCare prescription discount card. Such efforts can make a big difference in controlling ulcerative colitis.
Sources
- The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications, Gut (2006)
- Tachycardia: Fast heart rate, American Heart Association (2022)
- Systematic review with network meta-analysis: the efficacy of anti-tumor necrosis factor-alpha agents for the treatment of ulcerative colitis, Alimentary Pharmacology and Therapeutics (2014)
- Time to clinical response and remission for therapeutics in inflammatory bowel diseases: What should the clinician expect, what should patients be told, World Journal of Gastroenterology (2017)
- Remicade label, DailyMed (2022)