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The Biologics: TNF-a Inhibitors

In this section we have compiled numerous, informative resources regarding a new class of medications for AS and related diseases: The Biologics, TNF-a Inhibitors. These medications include Enbrel® (entanercept), Remicade® (infliximab) and Humira® (adalimumab). All three have been approved by the FDA for treatment of AS.

Quick Links

-Q&A Regarding the TNF-a Inhibitors-  -Patient Assistant Programs-
 -News Articles-  -Links to Other Online Resources-




Q&A Regarding the TNF-a Inhibitors

Once the fusing begins, is there a way to stop it or slow it?

John D. Reveille, MD, responds: The TNF-a blockers being used in AS seem to stop or slow radiographic progression in many AS patients. The problem is that they are expensive and we do not yet have long-term data on the safety profile. There are now international guidelines that we are using not only to help determine who needs the drug, but also who is most likely to benefit from the drug. We are trying to implement those with our patients. That is the only treatment that we are aware of right now that appears to stop the fusion, and whether or not they continue to work over time, remains to be seen.

In the January - February 2004 edition of Spondylitis Plus, the guidelines for prescribing TNF-a inhibitors are discussed. Click here to view the issue in our Spondylitis Plus archive in the Member Area.
How is the decision made on who needs the TNF-a blockers?

John D. Reveille, MD, responds: Right now, we are restricting them for patients who adhere to the New York modified criteria for AS (diagnostic confirmation criteria for AS). A one-page test called the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), which can be found on the SAA web site, scores an average on six scales between 0 and 10. A person needs to score a 4 on this on average, have active disease for at least four weeks, and have failed at least two NSAIDs. Of course, the usual contra-indications must be taken into account (chronic infections such as tuberculosis, cancer, or other rheumatic disease such as lupus). With the use of TNF-a blockers, the BASDAI in most patients will improve; however, if the treatment hasn’t worked within six to twelve weeks, then it most likely will not work. Bottom line: TNF-a blockers are very expensive, they work, but not every one with AS needs them.

Straight Talk On Spondylitis
Want more information on the TNF-a inhibitor class of medications as well as other treatments? Then our book, Straight Talk On Spondylitis is a perfect resource. You can click here for a sneak preview of the book, or
click here to buy now.

Why do we require NSAIDs and sulfasalazine before moving onto Enbrel® or one of the other TNF-blockers?

Paul M. Peloso, MD, responds: We know that exercise, physical therapy and NSAIDs work fine for some people. We don't know exactly what the percentage is, but it might be as high as 50%. In addition, the TNF-blockers are very expensive, and they have potential side effects. So the real issue is, if you don't need them, why take them?

What are the most serious potential side effects of the TNF-blockers?

Paul M. Peloso, MD, responds: The main side effect we see on a regular basis is increased infections. We need to test for TB before we use TNF-blockers, and we need to treat TB if a patient has it. There is a risk of increased sinus infections, bronchitis and pneumonia. Other issues that are still being investigated are the risk of lymphoma, congestive heart failure and multiple sclerosis. We are still trying to figure out how important those things are after TNF-blockers.

Question: I am considering being treated with one of the TNF-a inhibitors, and I was wondering what might happen to someone who has undetected pre-cancerous cells of the prostate, cervix, or anywhere else in the body where it may take a long time for cancer to show up. Has anyone talked about this, or are patients automatically pre-tested for these conditions before starting the TNF medications?

For information on this subject (and other questions regarding possible side effects), we suggest you visit the National Institute of Health web pages on the TNF-a Inhibitors:

ENBREL (Etanercept)
Patient Information

REMICADE (Infliximab)
Patient Information

Humira (Adalimumab)
Patient Information

 

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Patient Assistance Programs

Although the TNF-a inhibitors have shown very promising results in some people with AS, not everyone has access to them. There are programs that may be able to help.

  • The Patient Access Network Foundation - From the site: "The Patient Access Network Foundation is a non-profit 501(c)(3) organization dedicated to supporting the needs of patients that cannot access the treatments they need due to out-of-pocket health care costs."

  • Partnership for Prescription Assistance - From the site: "The Partnership for Prescription Assistance brings together America’s pharmaceutical companies, doctors, other health care providers, patient advocacy organizations and community groups to help qualifying patients who lack prescription coverage get the medicines they need through the public or private program that’s right for them."

  • Enliven: Enbrel Patient Assistance Program - From the site: "Enliven Services offers free information and assistance designed specifically for people who use ENBREL."

  • Remicade Patient Assistance Program - Remicade was recently approved by the FDA to treat AS.

  • Chronic Disease Fund - Their focus is to provide assistance to those under-insured patients who are diagnosed with chronic or life altering diseases that require the use of expensive, specialty therapeutics.

  • RxHope - From the site: RxHope is the only patient assistance Internet initiative financially supported by PhRMA (Pharmaceutical and Research Manufacturers of America) and participating pharmaceutical companies.

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In the July / August 2004 edition of Spondylitis Plus, We have a detailed overview of the TNF-a blockers.

Excerpt: "Enbrel, Humira and Remicade are biologics or biologic response modifiers (BRM), Biologics got their name because they are made biologically from living cells..." Click here to view the issue in our Spondylitis Plus archive in the Member Area. Not a member?
Then Click here to join!



News Articles

FDA Approves Remicade ® for Psoriatic Arthritis

Understanding the role of biologic medications in AS

Long Term Safety Data on the Biologics: Enbrel, Remicade

Enbrel and Remicade News

FDA Approves REMICADE for Patients with Ankylosing Spondylitis

The Latest on Remicade® (Infliximab) in the Treatment of Ankylosing Spondylitis

The Biologic Era: New Interest & Treatments in Spondylitis

Anakinra for Treating AS

Predicting an AS patient’s response to TNF-a treatment

FDA accepts supplemental biologics license application (sBLA) for Remicade® to treat AS

Determining who receives TNF-a therapy for Ankylosing Spondylitis

Weekly etanercept might replace twice-weekly doses

Patients on TNF inhibitors “concealing” adverse effects?

The Effect of tumor necrosis factor on the response of pneumococcal vaccination in patients with rheumatoid arthritis ankylosing spondylitis

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Links to Other Online Resources

The TNF Superfamily of Cell Regulators
Want to read some of the detailed science behind the tumor necrosis factor, or TNF? If so, here is a link to a PDF file that explains it in depth:
The TNF superfamily regulate a variety of immune and developmental events

Enbrel (etanercept)

  • Enbrel.com - Enbrel was developed by Amgen & Wyeth and this is their official Enbrel site.
  • Enbrel (etancercept) Info from NIH - More information on Enbrel from the National Institute of Health (NIH) / Medline Plus site including indications, side effects, etc.

Remicade (infliximab)

  • Remicade.com - Remicade was developed by Centocor, Inc. and this is their official Remicade site.
  • Remicade (infliximab) Info from NIH - More information on Remicade from the National Institute of Health (NIH) / Medline Plus site including indications, side effects, etc.

Humira (adalimumab)

  • Humira.com - Humira was developed by Abbott Laboratories and this is their official Humira site.
  • Humira (adalimumab) Info from NIH - More information on Humira from the National Institute of Health (NIH) / Medline Plus site including indications, side effects, etc.


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