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Dr Paul Froomes - Consultant Physician & Gastroenterologist - Infliximab for Crohn's Disease

Infliximab for Crohn’s Disease

What is Infliximab?

Infliximab belongs to a new class of drugs known as monoclonal antibodies. This particular drug blocks the activity of an inflammatory chemical in the tissue called tumor necrosis factor (TNF). Excessive TNF seems to lead to increased inflammation and damage in the tissues in disorders like Crohn's disease and rheumatoid arthritis. Because infliximab blocks TNF, it is known as “anti-TNF”.

What is it used for?

Infliximab is used for the treatment of patients with moderate to severe Crohn's disease for whom conventional therapy has not been effective. It is also used to treat Crohn's patients who have fistulas which are sinus-like tracts that most often run from the bowel to the perianal area and produce intermittent damage. Infliximab is not a cure for Crohn's disease.

How is it given?

Infliximab is given by intravenous infusion over a two-hour period. The dosage is determined by the patient's weight and the physician's determination of how many milligrams per pound of weight is appropriate.

Are there interactions with food or beverages?

There is no known interaction between this drug and any food or beverage.

Are there interactions with other drugs?

There are no known interactions between infliximab and other drugs including those that a Crohn's patient may be taking which include prednisone, Asacol, Pentasa, Azulfidine, Imuran and 6-MP (Purinethol).

Is there a problem if I have another disorder or disease?

At times, a drug may have a different or enhanced effect when other diseases are present. At other times, the drug may worsen or effect another disease. At present, there is no known adverse effect of this drug on other diseases.

What about allergies?

Allergies are known to occur with infliximab infusion. In clinical testing, about 7% of patients receiving their first infusion had a reaction. About 10% of patients had a reaction on their second infusion. Most of these were considered minor (see Side Effects). About 1% had what were considered more serious reactions, including hives, blood pressure drop or chest pain. Patients who developed certain antibodies in their blood after the first infusion were more likely to develop a reaction on subsequent infusions. The effect of infliximab in pediatric patients and the elderly is unknown.

What if I’m pregnant?

Most females now know that, if possible, no drug, including alcohol, should be taken during pregnancy or lactation. The potential danger, of course, is an injury to the fetus or baby. However, some drugs are much safer than others in this regard. So, the FDA has a grading system for each drug which reflects what is known medically. It ranks drugs from A, where medical studies show no evidence for danger to the fetus or mother, to B, C, D and X, where the medical evidence indicates increasing risk to the fetus which eventually outweighs any benefit to the mother. Infliximab is ranked B. Always consult your physician before taking any drug during or when planning pregnancy.

Most physicians will not want female patients who are already pregnant or trying to become pregnant to receive this drug. Further, males who are trying to father a child generally should not receive the drug. Nursing mothers should not receive this drug as its transmission in mother's milk and effect on the baby are unknown.

Are there other precautions?

Immune antibodies are proteins that the body may produce when another foreign protein is infused. This is, of course, what happens when you are vaccinated. With infliximab, certain antibodies may develop which may make an allergic reaction more likely with subsequent infusions.

Infections can occur after an infusion since the drug does block the body's response to infection and inflammation.

Malignancies have not been clearly seen to develop with infliximab. Long-term Crohn's patients who take other immune suppression drugs may have a very slight increase in a lymphoid tumor, called lymphoma. Infliximab is not known to contribute to any such risk.

How long is it safe to take infliximab?

Infliximab has been released by the FDA for use in 1998. It is a new drug, so long-term effects are not known. During clinical trials, long-term problems have not been seen.

How about side effects?

Adverse reactions can occur with any drug, even over-the-counter medications. Minor reactions generally go away on their own but if they persist, the patient should contact the physician. For major reactions that may occur after returning home from the infusion, the patient should contact the physician immediately. There are no known adverse effects of infliximab on sexual function. There are a number of side effects that can occur after an infusion. These include:

Minor:

  • Headache
  • nausea/vomiting
  • respiratory infection
  • fever
  • skin rash
  • itching
  • cough
  • muscle aches
  • dizziness + abdo pain

Major:

  • hives
  • shortness of breath
  • chest pain

Remicade / infliximab

Remicade has been reported to be capable of allowing the following very serious diseases to appear in users:

  • Lymphoma and other cancers;
  • Tuberculosis, especially extra-pulmonary and miliary tuberculosis;
  • Opportunistic infections, such as histoplasmosis, listerosis, aspergillosis, coccidiomycosis and pneumocystosis, sometimes manifested as life threatening sepsis and abscesses;
  • Multiple sclerosis, optical neuritis, transverse myelitis, and other neurological diseases; 
  • Aplastic anemia and other pancytopenias;
  • Serum sickness, which is a delayed hypersensitivity reaction which can be quite severe, and includes rashes;
  • Lupus.

This type of drug marks a new biological medicine approach to rheumatoid arthritis (RA). 

Remicade (infliximab)

Remicade is sold by Centocor, Inc., located in Malvern, Pennsylvania, which is owned by Johnson and Johnson.  This is a mouse-derived, genetically engineered chimerical monoclonal antibody, sometimes prescribed with methotrexate.  It is administered by infusion in the doctor's office. The usual IV dosage is three mg/kg per eight weeks.  Over 170,000 users.  It is given for moderate to severe rheumatoid arthritis, and Crohn's disease.

How does the drug work?

Our body produces the tumor necrosis factor (TNF) (a type of cytokine in the inflammatory process) as a means of defense against various diseases (among those being the serious diseases listed above).  They are held at bay.  It is believed that rheumatoid arthritis (RA) and Crohn's disease are diseases, on the other hand, which are caused by TNF.  Remicade inhibits TNF production by binding to the TNF cell receptors and blocks interaction.  It also has a prolonged terminal half-life which may contribute to some of its toxic properties.

It is therefore quite explicable how the serious diseases, which might become the basis for a lawsuit, arise.  The drugs purposefully inhibit the TNF, and the body loses its immunity against the diseases, the "seeds" of which are lurking in the body.  The drug allows the side effects to arise, which can cause life-threatening and possibly fatal outcomes.

The mechanisms of action for the adverse drug reactions can be grouped into the following categories:

  • Infections;
  • Immunogenicity; (auto-immune diseases)
  • Delayed hypersensitivity; and
  • Infusion-related reactions

We are not talking about rare side effects.  Although they have a small market compared to big drugs like Vioxx and Celebrex, Enbrel was second in total ADR reports to the FDA AERS program in 2001 (6789 reports), and Remicade was 12th (1935 reports).
Remicade-A Chronology Focusing on Labeling
August 1998- On market for Crohn's disease.
November 1999-FDA approved for RA  (with methotrexate) (expanded use Dec. 2000)
1999-Added to WARNINGS section of labeling, in boldface, warning about infections and sepsis.  Not to give if there is a new infection; use caution if there is a history of recurring infections; and stop if serious infection arises.
October 2001-Added to WARNINGS, in a boldface box, warnings about TB and other opportunistic infections, including histoplasmosis, listerosis, and pneumocystosis.  The doctor is to do tests for latent TB before putting the patient on the drug.  The TB is described as disseminated or extra-pulmonary.
October 2001-Dear Doctor letter: warning not to give to persons with congestive heart failure.
January 2002-FDA issues warning about serious nervous system problems, involving demyelinization, producing MS and other conditions; patients warned to watch for vision changes, and so forth. (This was based upon ADR reports to FDA).
March 2002-Centocor files NDA for treating Crohn's in remission.
April 2002-New York Times story about improper marketing, money inducements to doctor to use.

Last Updated ( Wednesday, 20 February 2008 )