What Is Remicade (infliximab)?

Date: Jul-25-2012Remicade (infliximab) is a TNF inhibitor, a monoclonal antibody against tumor necrosis factor alpha (TNF-α), that is prescribed for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, chronic plaque psoriasis, psoriatic arthritis, Crohn's disease, and ankylosing spondylitis. Infliximab is used to alleviate the symptoms of pain and inflammation.

In September 2011, the US FDA approved Remicade for treating children aged 6 or more years whose ulcerative colitis responded inadequately to conventional therapy.

Infliximab first came onto the market in August 1998, when the US FDA (Food and Drug Administration) approved it for the treatment of Crohn's disease.

Remicade belongs to a class of drugs known as "biologics", therapies based on proteins which are usually antibodies. These proteins have been developed through genetic engineering. Remicade is a fully human monoclonal antibody; a type of protein that searches out, finds and binds to specific proteins.
Autoimmune diseases and TNFα
Scientists and specialists still do not fully understand exactly why autoimmune diseases occur. According to many studies, TNFα (Necrosis Factor Alpha) seems to play a major role in inflammation that is present in most autoimmune diseases, including Crohn's disease, ankylosing spondylitis, rheumatic arthritis and the other illnesses which benefit from Remicade treatment.

TNFα causes inflammation when the immune system is activated.

TNFα delivers messages between cells in the body. Excess levels of TNFα can make the immune system attack healthy tissue and cause inflammation.
How does Remicade work?
Remicade binds to Necrosis Factor Alpha and blocks its inflammatory effect; this reduces inflammation and pain for patients with autoimmune diseases. Autoimmune disease are incurable, but Remicade can help reduce the symptoms of pain and inflammation.

Remicade can start making a difference within 48 hours for some patients, while others may have to wait several weeks. Patience, perseverance, and adhering to the treatment regime are important for best results.

One of the drawbacks, though, is that because Remicade reduces immune system activity, it can also undermine the body's ability to infections. Patients on Remicade who think they might have an infection should tell their doctor straight away.
How is Remicade (infliximab) administered?
Remicade (infliximab) is administered directly into a vein (intravenous infusion). This is done in a hospital or clinic.







It cannot be taken orally because the drug's active ingredient would be destroyed.
Who benefits from taking Remicade?
Moderate to severe rheumatoid arthritis - sometimes known as rheumatoid diseases or RA. RA is a chronic, progressive autoimmune disease which causes inflammation and pain in the joints, as well as surrounding tissue. Sometimes other organs are affected. RA can be severely disabling.

Active psoriatic arthritis - about 10% of patients with psoriasis also suffer from joint inflammation.

Active ankylosing spondylitis - long-term inflammation of the sacroiliac joints and the spine. The sacroiliac joints join the hips to the spine. There may be considerable pain and stiffness in and around the spine area. The vertebrae may eventually fuse together (ankylosis). Some patients with Crohn's disease and psoriasis also suffer from ankylosing spondylitis.

Professor Jurgen Braun, M.D., from the Free University of Berlin, led a clinical study which demonstrated that patients with ankylosing spondylitis who were given Remicade over 24 months had significant improvements in spinal mobility. He added that they also showed sustained reductions in spinal inflammation.

Moderate to severe Crohn's disease - a long-term condition in which there is inflammation in the digestive tract, which can occur in any part of the gut, but is more common in the lower part of the small intestine (ileum). Pain is a common feature of Crohn's disease, as is diarrhea.

Moderate to severe ulcerative colitis - a relatively common, chronic disease that causes inflammation of the large intestine (colon). Ulcerative colitis is a form of inflammatory bowel disease. The colon becomes inflamed. In severe cases painful ulcers may form, which may bleed and produce pus and mucus. Clinical studies carried out in Belgium showed that Remicade significantly reduced the incidence of bowel surgeries in patients with ulcerative colitis.

Moderate to severe chronic plaque psoriasis - the most common type of psoriasis. There are well-defined patches of red raised skin (plaques), usually around the knees, elbows, scalp, trunk and nails. However, plaques may appear anywhere. Scale accumulates on the plaques and then flakes off. Patients have extremely dry skin, which can be itchy, cracks easily, and is often painful.

A 2008 study showed that patients treated with Remicade experienced rapid and substantial improvement in psoriasis in critical regions of body.
Important information regarding Remicade
Remicade can lower the patient's ability to fight infections. Seniors on Remicade have been known to develop serious viral, bacterial or fungal infections that have then spread all over the body, including TB (tuberculosis) and histoplasmosis. In some rare cases there have been deaths. It is vital that patients are checked for signs of TB while on Remicade.

Some teenagers and children on TNF-blocker medications have developed unusual cancers. Cases of a rare and fatal form of lymphoma - Hepatosplenic T-cell lymphoma - have been reported in a small number of mostly male teenage/child patients with Crohn's disease or ulcerative colitis who were on a combination of Remicade and azathioprine or 6-mercaptopurine.

Tell your doctor if you:

Have or have had TB (tuberculosis)
Have been in close contact with anybody with TB
Lived someplace where histoplasmosis or coccidioidomycosis were endemic
Have recurring infections
have an immune system problem
Have diabetes
Have or had cancer
Have any cancer risk factor, such as COPD, or some types of psoriasis phototherapy
Have or had any heart condition
Have HBV (hepatitis B virus) infection. Or you suspect you may be a carrier (the doctor can test)
Have a disorder of the nervous system, such as MS (multiple sclerosis)

The doctor has to know about any medications the patient is currently on before deciding on whether to prescribe Remicade, including vaccines or Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab).

Women who plan to become pregnant, are pregnant, or are breastfeeding or plan to do so should tell their doctor.

Patients should not be given a live vaccine while taking Remicade.

Women who took Remicade while pregnant need to tell the baby's pediatrician and nurse before any pediatric vaccines are administered.

Common side effects linked to Remicade usage

Coughing
Rash
Sinus infections
Sore throat
Stomach pain

More serious side effects linked to Remicade usage

If you experience any of the side-effects below, tell your doctor immediately:

Any infection, fatigue, fever, flu, alterations in skin. Anything that may indicate there is an infection
Any signs of cancer
Liver problems, including jaundice
Feel tired, unwell, have a poor appetite, skin rash, joint pain (could be a reactivation of hepatitis B virus)
Any signs of a blood disorder, such as persistent fever, bleeding, pallor, or bruising.
Any signs of a nervous system disorder, including weakness, tingling, numbness, changes in vision, or seizures
Any injections during or following the infusion, such as breathing problems, chest pains, changes in blood pressure, swelling of the hands or face, chills, or fevers
Lupus-like syndrome - a persistent pain/discomfort in the chest, joint pain, skin rash on the arms or cheeks that seem to get worse when exposed to sunlight.
Worsening or new psoriasis symptoms

Remicade is Marketed by Janseen Biotech Inc. in the United States, Mitsubishi Tanabe Pharma in Japan, Xian Janssen in China, and Schering-Plough (part of Merck & Co) in the rest of the world.

Written by Christian Nordqvist

View drug information on Actemra; Kineret; Orencia.

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