Sarcoidosis Answers for Physicians, Nurses and Patients

Here at SarcInfo, between 2002 and 2004, we identified the cause of Sarcoidosis, and successfully trialled a curative antimicrobial therapy. During 2005 and 2006 the US FDA designated the antibiotics Clindamycin and Minocycline as Orphan Products in the treatment of Sarcoidosis, and studies are ongoing elsewhere.

For information about this breakthrough, please post your questions at the current study-sites of the Autoimmunity Research Foundation.
 
This archive of the historic study is maintained by volunteers from the Foundation. The material here provides useful background, but most of this site is now out-of-date.

 

** Patient Tutorials **

 Click here to read "WHY DID I GET SARCOIDOSIS? WHY ME? 

  Click here to read "REMISSION IN SARCOIDOSIS"  

 How a Pathologist can see Bacteria causing Sarcoidosis 

"How does Doctor measure my ACE, and my D-metabolites?"

 Weaning from Prednisone

 Protecting your eyes in Sarcoidosis

Vit.D and Calcium in Sarcoidosis

Hypervitaminosis D Symptoms    The SarcInfo F.A.Q.

Medical Abbreviations          CBC Radio Show

Protocol Phase 1-First 3 months

 

** Papers for Physicians **

Antibacterial Therapy induces Remission 

Implications for Autoimmune Disease 
(Here is Fulltext preprint)

Antibacterial mechanisms for ARBs 

Antibiotics in Sarcoidosis- The 1st Year 

Rationale for abx in Sarcoidosis 

1,25-D and Angiotensin II

"New Treatments Emerge.."

Jarisch-Herxheimer in Sarcoidosis

Vit.D and Calcium in Sarcoidosis

Protocol Phase 1-First 3 months

The NIH ACCESS Study finds Sarcoidosis does not go away - Click here to see, and print, the brochure


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 Warnings:Enbrel, Remicade,Thalidomide
Author: Belinda (---.dsl.rcsntx.swbell.net)
Date:   01-17-03 21:04

Here are some reports to bring to the attention of anyone contemplating taking, or taking, Etanercept (Enbrel), Infliximab (Remicade), Pentoxyfylline or Thalidomide.

These drugs are anti-TNF-alfa therapies. The reports below were gathered from the FDA's database for monitoring drug adverse events. The significant side effects reported below include symptoms similar to sarcoidosis, ranging from difficulty walking to malaise, cough, dyspnea, interstitial pneumonitis, Demyelination, and lymphoma (cancer), and they developed within the first month or two of taking the drugs, in some cases.

Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration Dec 2002 issue of Arthritis and Rheumatology
CONCLUSION: Although data from a case series such as this cannot establish a clear causal relationship between exposure to these medications and the risk of lymphoproliferative disease{Admin: including cancer}, the known predisposition of patients with RA and CD {Admin: and Sarcoidosis} to lymphoma, the known excess of lymphoma in other immunosuppressed populations, and the known immunosuppressive effects of the anti-TNF drugs provide a biologic basis for concern and justification for the initiation of additional epidemiologic studies to formally evaluate this possible association.

Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor alpha antagonists infliximab and etanercept Oct 2002 issue of Arthritis and Rheumatology
CONCLUSION: Postlicensure surveillance suggests that acute life-threatening histoplasmosis may complicate immunotherapy with TNFalpha antagonists, particularly infliximab. Histoplasmosis should be considered early in the evaluation of patients who reside in HC-endemic areas in whom infectious complications develop during treatment with infliximab or etanercept.

Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides Dec 2001 issue of Arthritis and Rheumatology
CONCLUSION: Further surveillance and studies are required to better define risk factors for and frequency of adverse events and their relationship to anti-TNFalpha therapies. Until more long-term safety data are available, consideration should be given to avoiding anti-TNFalpha therapy in patients with preexisting multiple sclerosis and to discontinuing anti-TNFalpha therapy immediately when new neurologic signs and symptoms occur, pending an appropriate evaluation.

Trevor, may I count on you for an explantion of TNF-alfa in sarcoidosis?

Belinda

 
 Re: Warnings:Enbrel, Remicade,Pentoxyfylline,Thalidomide
Author: Admin (---.vnnyca.adelphia.net)
Date:   01-20-03 20:40

The key thing to note about the studies that recommend the use of these drugs is that they only recommend them for "Chronic Sarcoidosis". That is doctors-speak for "you are going to die, soon, anyway" (not quite a fair translation, but you get my point.

So if you are at your wits end, prepared to try anything, you might be offered these drugs instead of antibiotics and ARBs.

Before you accept them, have a long think about the Thalidomide study:
Several of the most notable sarc experts in the USA produced a report saying "The drug was well tolerated and may be a useful alternative to systemic corticosteroids" (full text) while another group of doctors testing Thalidomide for 'Age related Macular Degeneration' halted their study early because they judged the same side effects to be too damaging for their patients (Chet Scerra, Ophthalmology Times, October 15 2001) (see these course notes). The side effects noted were "drowsiness, dizzyness, shortness of breath and irreversible peripheral neuritis (numbness)".

The FDA prescribing instructions for Thalidomide say "Thalidomide is known to cause nerve damage that may be permanent", yet when Drs Baughman, Judson, Teirstein, Moller, and Lower wrote up their study they chose to downplay the 50% incidence rate amongst their study patients of this most crippling side-effect by saying "The complaint of numbness was subjective and may have been overreported".

So you need to be awfully careful that your perception of acceptable risk is similar to that of your physician

..trevor..

 
 Re: Warnings:Enbrel, Remicade,Pentoxyfylline,Thalidomide
Author: Admin (---.vnnyca.adelphia.net)
Date:   01-25-03 06:24

Reuters has just reported that Enbrel may increase the severity of Congestive Heart Failure.

You can read about it here

..Trevor..

ps: People have asked why I am so "down" on these TNF-alpha drugs. The reason is simple - when you really understand the inflammatory process, these drugs are NOT the right way to solve the problem. They are going after TNF-alpha, and you cannot just go out and inhibit one of the cytokines without expecting problems.
IMO, of course...

 
 Re: Warnings:Enbrel, Remicade,Pentoxyfylline,Thalidomide
Author: Belinda (---.dsl.rcsntx.swbell.net)
Date:   02-19-03 23:32

Here are the "Dear Doctor" letters, from the Federal Drug Administration website, warning of some risks of some biologics that are being used in sarcoidosis:

Use of Remicade (infliximab) and reports of tuberculosis, and other serious opportunistic infections such as histoplasmosis, listeriosis and pneumocystosis. October 5, 2001

Higher incidences of mortality and hospitalization for worsening heart failure in patients with moderate-to-severe congestive heart failure treated with Remicade (infliximab) October 18, 2001

Rare cases of central nervous system disorders, including demylinating disorders such as multiple sclerosis, myelitis, and optic neuritis have been reported in patients with rheumatoid arthritis who have received Enbrel therapy. October 10, 2000

Consult the letters for instructions on reporting adverse events related to medication. Consumers themselves may report adverse events.

Belinda

PS These are PDF files so you need Adobe Reader to read them.

 
 Re: Warnings:Enbrel, Remicade,Pentoxyfylline,Thalidomide
Author: Admin (---.vnnyca.adelphia.net)
Date:   04-28-03 12:51

Daniel said (on 28 April 2003):

Trevor, just ran across this article, more bad news for the Steroid camp.

Here is an August 15, 2001 news article
about Remicade and tuberculosis from the Johns Hopkins website at URL
http://www.hopkins-tb.org/news/8-13-2001.shtml

"Remicade Takers to Get TB Tests [L. Neergaard, August 15, 2001]:
WASHINGTON (AP) -- Rheumatoid arthritis patients must be tested for tuberculosis before they begin taking a treatment called Remicade, the drug maker and the government announced Wednesday. Patients using Remicade are at least four times more likely than average Americans to get active tuberculosis, the Food and Drug Administration estimates. The Problem: Apparently the drug suppresses the users immune systems enough that if they unknowingly carry the TB germ, the respiratory illness can suddenly flare up and turn in to ACTIVE TB. The warning is serious because untreated, TB can kill -- and it's also an airborne illness that these patients could spread to family and friends. Worldwide, 88 cases of tuberculosis have been reported among the estimated 170,000 people who have tried Remicade, FDA's Dr. Bill Schwieterman said Wednesday. Fifteen of those people died. Some 2 billion people worldwide are infected with TB and risk developing an active case of the disease. In the United States, TB cases dropped to a record low of 16,377 last year. But the illness is a continuing threat here, with increased foreign travel and immigration from countries where TB
is common. Rheumatoid arthritis afflicts more than 2 million
Americans when their immune systems go awry and attack their joints, causing severe swelling, pain and stiffness. Remicade is a bioengineered drug that roams patients' blood to sop up an immune system protein called tumor necrosis, a factor responsible for much of the swelling. But that immune suppression, so important in fighting rheumatoid arthritis, can leave users at a higher risk for serious infections. Remicade's label has long carried warnings about various infections, but it now will carry a boxed warning in bold type about the TB risk – the strongest warning possible for a prescription drug. The warning doesn't say people should stop using Remicade. The risk of activating latent TB appears highest in the first three to six months of use, so doctors should carefully evaluate those patients, Schwieterman said. But before prescribing Remicade to a first- time user, doctors should test for TB -- it's a simple skin test -- and treat TB carriers, the FDA concluded.
Manufacturer Centocor Inc. will send letters to thousands of doctors who prescribe Remicade, both for rheumatoid arthritis and the bowel ailment Crohn's disease, alerting them to the warning. A similar rheumatoid arthritis treatment called Enbrel also suppresses the immune system and carries warnings that users face the risk of serious infections. But so far, Enbrel users don't seem to face a special TB risk, Schwieterman said."

http://www.hopkins-tb.org/news/8-13-2001.shtml

 
 Re: Warnings:Enbrel, Remicade,Pentoxyfylline,Thalidomide
Author: Admin (---.vnnyca.adelphia.net)
Date:   04-28-03 13:40

Take a careful listen to the CBC radio show "Bacteria Revolution" (click here)

Dr Lynn Margulis explains some photos of bacteria changing back and forth from the CWD form to the normal form. She says that when the environment is harsh (eg in granuloma) they go into CWD form, but when the environment is favorable (eg: when someone's immune system has been totally shut down by these silly drugs) they change back to the normal spirochette bacteria.

I guess this is why some CWD mycobacteria might transition to TB bacteria.

I wonder how the pulmonologists explain this away??

..Trevor..

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Radha Moorthy (---.ny325.east.verizon.net)
Date:   06-02-03 08:31

My daughter is suffering from Spondylo arthropathy and has been recommended to treating herself with Enbril. The side effects seems scary. Could you suggest other sources where we could look up for further side and long term effects of enbril.

Thanking you,

Sincerely,

Radha Moorthy

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Admin (---.vnnyca.adelphia.net)
Date:   06-02-03 08:44

Radha,
Enbrel is a TNF-alpha antagonist. It you work through the biochemistry in the paper "New Treatments Emerge.." you will find that there is no TNF-alpha generated if the Angiotensin II is blocked by an ARB. These are a very safe class of drugs, used by millions for blood pressure. But if you dose them as suggested in that paper, 40mg Benicar every 6-8 hours, they apply a very effective block against the Th1 inflammation and the TNF-alpha it releases.

Amgen is not going to tell you this because they make 100s of million of dollars by selling Enbrel.

There are no long-term side-effects of Enbrel documented yet. But the short term side effects are scary, and portend long-term problems, IMO. It is too new. But it is messing with the biochemistry at the level of individual cytokines, and that is not something I would recommend.

I am not sure exactly what course your daughter's "Spondylo arthropathy" ("auto-immune" arthritic pain in the vertebrae) is going to take. I strongly recommend you have the degree of systemic inflammation checked by getting bloodwork done for the D metabolites. Make sure you report the actual numbers from those tests here - the labs don't know how to interpret that data yet. You can read more about that data at this link.

..Trevor..
ps: I forgot to say that all these Th1 inflammatory conditions are due to CWD bacteria. Minocycline Antibiotic is the therapy to actually eliminate such infections. ARBs mitigate the symptoms, and take you through the herxheimer.

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: angie (---.cox-internet.com)
Date:   06-05-03 14:19

I have read info regarding enbril. My father is in the hospital with very high fever so far nothing has shown up in test. any info about drinking alcohol and enbril side effects
angie

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Meg (---.188.232.59.euc.wi.charter.com)
Date:   06-05-03 20:36

Hi Angie,

Welcome to SarcInfo. I'm sorry your father is so ill. Does he have sarcoidosis?

Excessive alcohol intake can complicate any illness. What are the doctors saying?

Meg

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: bruce wilson (---.s113.tnt1.annp.md.dialup.rcn.com)
Date:   02-21-04 06:32

My girlfriend has osteoperosis and the beginnings of chrones-her mother died from chrones at the tender age of 35, she is currently having infusions of remicide along with all her current pills, she is also a heavy drinker and smoker-what sort of personality disorders should I expect as there seem to be a lot.

Regards,

bruce wilson

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Meg (---.115.74.164.euc.wi.charter.com)
Date:   02-21-04 07:39

Bruce,

Your girlfriend's problems are beyond the scope of our Internet Study. Please talk with her doctor about your concerns.

Good luck,

Meg

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Hayden (---.s514.tnt5.lnhva.md.dialup.rcn.com)
Date:   02-22-04 12:21

Trevor

It seems clear that blocking TNF is not a good thing to do if there are alternatives. My question is this: Blocking Ang II also stops TNF so why shoudn't the same warnings apply to Benicar?

Hayden

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Meg (---.115.74.164.euc.wi.charter.com)
Date:   02-22-04 15:42

Hayden,

Trevor is having computer problems so he may answer later. When I asked Trevor that same question, this is what he said:

"The ARBs stop TNF-alpha from being released from the macrophages. They
also stop the other cytokines.

Infliximab is a TNF-alpha receptor (called an antagonist) which just binds to any TNF-alpha floating around, and leaves the rest of the inflammatory cytokines intact.

ARBs work at a higher level than the cytokines or chemokines. They are
obviously a superior way to go."

..Trevor..

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Hayden (---.s598.tnt3.lnhva.md.dialup.rcn.com)
Date:   02-23-04 09:24

Meg

Thank you for your reply. I too believe that Benicar is superior to Enbrel and the others. But that was not my question.

Enbrel etc. block TNF but have certain cautions for those who take them.

Benicar blocks TNF (and other cytokines). Should the same cautions apply?

Hayden

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Admin (---.dsl.dock.net)
Date:   02-23-04 09:43

Hayden,
No, you have it wrong.

Benicar blocks the production of ALL inflammatory cytokines, including TNF-alpha, by reducing the inflammation.

Enbrel and Remicade seek out just one of those inflammatory cytokines, TNF-alpha, and bind to it so as to eliminate it from the bloodstream. All the other cytokines and chemokines produced by the inflammation are left intact. This is a totally different mode of action on the inflammatory immune response.

..Trevor..

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Hayden (---.s486.tnt1.lnhva.md.dialup.rcn.com)
Date:   02-23-04 13:39

Trevor
Please excuse me for being a slow learner. I understand that the way the TNF is blocked is very different. But regardless of how it is done the end result is that TNF is blocked. The following is a quote from Mayo Clin Proc, June 2001, Vol 76, p 574.


"With the central role that TNF plays in our immune system, it is naive to believe that compete blocking of TNF for long periods of time will be without toxic effects."

Hayden

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Admin (---.vnnyca.adelphia.net)
Date:   02-23-04 13:47

Hayden,
If some of the best medical minds can't understand TNF-alfa and cytokines and NuclearFactor-KappaB then you should not be ashamed that you are learning slowly.

Mayo says that there should not be "complete blocking of TNF". I agree with them. You see Benicar is not BLOCKING the TNF-alpha which exists, it is INHIBITING the release of TNF-alpha from the sarc Th1 immune reaction. Big difference.

Prednisone also inhibits the release of TNF-alpha, but does it by shutting down NuclearFactor-kappaB, a protein that is needed to build bone and combat high blood sugars. Which is not good. Benicar, on the other hand, prevents the AT1 receptors in the inflammation from signalling to NuclearFactor-kappaB that it is time to migrate to the nucleus, and release a messenger RNA that begins the cytokine release. Again, two totally different mechanisms.

..Trevor..

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Hayden (---.s486.tnt1.lnhva.md.dialup.rcn.com)
Date:   02-23-04 13:55

Trevor
Thanks for the explanation. I thought all TNF came from Ang II and with that blocked there would be no TNF in the body.

Hayden

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: bpeck (---.bluebird.ibm.com)
Date:   02-26-04 09:59

Hayden and Trevor:

First big difference is that the anti-TNF antibodies from the injectable
RA drugs are grown in mice.

Here is an excellent site that explains most of the anti-TNF injectable
drugs for RA.

http://www.hopkins-arthritis.som.jhmi.edu/rheumatoid/tnf.html

Barb

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Belinda (---.dsl.rcsntx.swbell.net)
Date:   06-08-04 07:11

A new report is out, based on the FDA adverse event reporting system, collected through September 2002. Here it is:

Granulomatous infectious diseases associated with tumor necrosis factor antagonists.
Clin Infect Dis. 2004 May 1;38(9):1261-5. Epub 2004 Apr 15.
PMID: 15127338 [PubMed - indexed for MEDLINE]

Full text of the article is found at this URL: http://tuberculosis.umdnj.edu/granul.pdf

Belinda

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Belinda (---.dsl.rcsntx.swbell.net)
Date:   06-14-04 10:53

This post has been moved to the appropriate thread by a moderator.
Belinda
----------------

Author: Kimberley Kalish (170.122.250.195)
Date: 06-14-04 08:48

I have know about my sarcoidosis for about 8 years now. I have a chronic problem with it and my lungs. I have been on and off prednisone and other drugs for most of the time. I definitely feel better on then off prednisone. I have a new MD and he has suggested I try Remicade. My sarcoidosis is now classified as Stage 3. I am a little concerned about the infection factor as I work in an invasive lab in a hospital. I am already showing some bone degeneration from the prednisone, though. Any suggestions or information?

farmkim

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Meg (---.188.240.36.euc.wi.charter.com)
Date:   06-14-04 17:08

Hi Kimberly,

Welcome to SarcInfo. You are wise to consider getting off prednisone. The risks far, far outweigh the benefits. Bone degeneration is also caused by high 1,25-D. Please ask your doctor to measure both D-metabolites asap.

Prednisone is used as a first line treatment because it ruthlessly suppresses the body's immune system. It stops the body from fighting the bacteria, and consequently reduces the inflammation the body produces during that fight. That is why you feel better on prednisone.

But you cannot shut down the body's immune response for very long. The bacteria multiply in the tissues without any hindrance once the Prednisone has shut down the body's immune reaction. At some time the sheer amount of toxin they are generating will become uncontrollable, even if the dose of Prednisone is continually increased. When you stop taking the Prednisone your condition will relapses, to a state much worse than when they started on the steroid.

With all due respect to your new physician, you should know that the staging system is no longer considered accurate by sarcoidosis experts because it only reflects the condition of your lungs. His suggestion to take Remicade is part of a trend to try drugs that allow you to cut back on prednisone. They are called steroid-sparing.

You are right to be concerned about acquiring an infection if you are taking Remicade. If Remicade was aimed at the cause of your sarcoidosis, it might be worth the risk. But it just suppresses the immune system in a different way than prednisone.

Please read this entire thread for lots of background information about Remicade. There are many studies about its risks. Remicade does work, in that sarcoidosis patients have reported feeling much better for the first few months. It is then that the problems usually start. Personally, I don't think any drug which causes death as frequently as Remicade is worth paying $18,000 a year for. Minocycline will only cost you about $300 and promises far less excitement. Just resolution of your symptoms.

Please let us know if you have any other questions.

Meg

 
 Re: Warnings:Enbrel, Remicade,Thalidomide
Author: Belinda (---.dsl.rcsntx.swbell.net)
Date:   12-26-04 17:29

FDA Issues New Warning Regarding Remicade

The FDA issued a new warning regarding Infliximab (Remicade) on December 22, 2004.

The new FDA warning is regarding severe hepatic reactions - including acute liver failure - in patients receiving Remicade. The FDA-ordered Dear Doctor Letter and label with new safety warning are available at the FDA website.

Belinda

*MODERATOR* Dx: FM 80's, sarcoidosis '01; Lung, skin, spleen, liver and neuro. Refused Prednisone. 7/02 1,25-D 61.1, 25-D 14.3. MP since '02 PhaseIII with symptoms gone, slight Herx. Improved PFTs, CTs, X-ray, energy and stamina. I walk 3-4 mi daily now

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This is an archive site, membership and posting are no longer allowed.

Historical perspective on Sarcoidosis:


  1. The John's Hopkins Vasculitis Center: Prednisone Side Effects (incl. PHOTOS and PHOTOGRAPHS)
  2. Steroid-Treated patients Have higher risk of Cardiac problems
  3. "Evidence Growing That Inhaled Steroids, Like Steroid Pills, Can Cause Bone Loss"
  4. "Corticosteroids contribute to the prolongation of the disease by delaying resolution"
  5. "No data to suggest that corticosteroid therapy alters long-term disease progression"
  6. Cochrane Review - "Oral and Inhaled Corticosteroids have no discernible effect on lung function"
  7. Prednisone Improves Symptoms but not Lung Function in Sarcodiosis
  8. There is no conclusive evidence that corticosteroids affect the development of irreversible pulmonary damage
  9. Clinical Guideline For Treatment Of Arthritis Pain
  10. Angiotensin II receptor on BALF macrophages from Japanese patients with active sarcoidosis

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