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REMICADE for Crohn's

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The approval for REMICADE maintenance therapy in fistulizing Crohn’s disease was based on the results of the ACCENT II study. ACCENT II stands for "A Crohn’s disease Clinical study Evaluating infliximab in a New long-term Treatment regimen." in patients with fistulizing Crohn’s disease.

Who were the study participants?

A total of 296 patients with fistulizing Crohn’s disease were studied in clinical centers in North America, Europe, and Israel. To enter the study, patients had to present with either single or multiple draining enterocutaneous fistulas, including perianal and abdominal fistulas, for at least 3 months. Women with rectovaginal fistulas were also included as long as they had at least one other enterocutaneous fistula present. Patients were evaluated for a fistula response. A fistula response was defined as a reduction of at least 50 percent in the number of draining fistulas from the start of the study and maintained over a 4-week period of time. Additionally, patients were assessed to see how long they could keep their response while on therapy. All patients included in this study had never received REMICADE before, and many were taking other medications, such as steroids, 5-aminosalicylates (e.g. mesalamine), or antibiotics.

Which medications were given to study participants?

All participating patients were each given 3 doses of REMICADE 5 mg/kg. The first dose was infused at the start of the study (Week 0) the second dose at Week 2, and the third dose at Week 6. Patients were checked for a fistula response throughout the 54-week study period at specified time points. Patients who achieved a fistula response with REMICADE at Week 10 and maintained that response at Week 14 were placed into one of 2 groups.

Group A was made up of patients that achieved a fistula response at Week 10 and maintained that response at Week 14. These patients were given additional doses of REMICADE 5 mg/kg once every 8 weeks for the remainder of the study. This means they were given 5 milligrams of REMICADE for each kilogram of their body weight (a kilogram is equivalent to 2.2 pounds).

Group B was also made up of patients that achieved a fistula response at Week 10 and maintained that response at Week 14. These patients received placebo (an inactive substance). Placebo patients were not given maintenance REMICADE therapy. Instead these patients were given an infusion that had no medical effect on their fistulizing disease. These infusions were given every 8 weeks through Week 46. This group was the control group that was used to compare the results with group A.

Results from the ACCENT II study:

1. REMICADE induced and maintained fistula response
At Week 14 of the study, almost two-thirds of all patients treated with the 3 initial doses REMICADE had a fistula response. At Week 54, more patients in Group A (38%) had no draining fistulas compared to patients in Group B (22%). Also, Patients in Group A had a longer time until they lost fistula response (greater than 40 weeks) compared to Group B (14 weeks). In other words, patients in Group A experienced fistula closure for a longer duration than patients in Group B.

2. REMICADE reduced the number of hospitalizations and surgery
When looking at all patients that achieved and maintained a fistula response at Weeks 10 and 14, it was found that the average number of hospitalizations among those patients who received REMICADE maintenance therapy was less than that among the placebo maintenance treated patients.

IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE^® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE^®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE^®.
Lived in a region where certain fungal infections such as histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, have diabetes or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take REMICADE^®.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Nervous system disorders (such as multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while REMICADE^®.

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE^®.

You should tell your doctor right away if you have any of the signs listed below:

Infections (such as TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers in adults and children.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss it with your doctor.
(Requires Adobe^® Reader^®. Click here to download.)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Last Updated: April 13, 2010