Ankylosing Spondylitis and REMICADE

REMICADE treats pain within the spine and improves many other symptoms of active AS.

If you have ankylosing spondylitis (AS), you already know that this disease primarily affects the spine — it can limit how you move, how you feel, and your ability to accomplish everyday activities. AS is also a progressive disease that can lead to long-term disability. REMICADE is a medicine that treats the back pain, as well as other symptoms caused by AS.

For many patients with active AS, REMICADE can provide rapid and sustained symptom relief in as soon as two weeks. REMICADE has been proven to relieve many ankylosing spondylitis symptoms, such as spinal pain (pain in the back, neck, and hip), fatigue, and morning stiffness. By improving the many symptoms of AS, REMICADE can quickly and effectively help you accomplish and enjoy normal, everyday activities with less pain. Individual results may vary. Only your rheumatologist can determine if REMICADE is right for you.

Here are some reasons that you should talk to your rheumatologist to see if REMICADE is right for you:

REMICADE works with your immune system to block TNF-alpha, a protein in your body that triggers the inflammation leading to ankylosing spondylitis symptoms.
REMICADE is an advanced medicine that can reduce symptoms of AS in as soon as two weeks after you begin treatment. Individual results may vary.
REMICADE has been proven to relieve many AS symptoms, such as spinal pain (pain in the back, neck, and hip), fatigue, and morning stiffness. Individual results may vary.
REMICADE provides infrequent dosing that is customized according to your body weight. REMICADE is given as a two-hour IV infusion by a healthcare professional. You may need REMICADE only once every six weeks after the first three doses. That could be as few as nine times a year.
REMICADE has been used to treat more than one million patients worldwide for conditions such as plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease in adults, pediatric Crohn’s disease, ulcerative colitis, and ankylosing spondylitis.
REMICADE is covered by most insurance plans including commercial insurers, Medicare, and Medicaid. Coverage policies may vary by insurers or even between plans offered by the same insurer. If you have any questions about insurance coverage or reimbursement, you should first call your insurance company or Medicare. If you have any questions or concerns, or if you need additional information related to medical coverage or patient assistance for REMICADE, you may call AccessOne^SM toll-free at
1-888-ACCESS-1 (222-3771) for free assistance.

Individual results may vary. Talk to your doctor to see if REMICADE is right for you. Please read the Medication Guide and discuss any questions or symptoms with your doctor.

For further information about ankylosing spondylitis and REMICADE, please visit the following resources:

Also see:

Strong enough to change the course of AS therapy. This brochure provides information about AS and how REMICADE works to treat AS. En Español
(Requires Adobe^® Acrobat^® Reader. Click here to download)

Ankylosing Spondylitis Lead Photo

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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: January 19, 2009