Large cell T-cell lymphoma developing during therapy of pilaris with Stelara

[kiny]

http://link.springer.com/article/10.1007%2Fs00105-012-2526-5

CD30-positives anaplastisch großzelliges T-Zell-Lymphom unter immunsuppressiver Therapie einer Pityriasis rubra pilaris mit Ustekinumab

January 2013

Dr. D. Humme,M. Beyer,H.-J. Röwert-Huber,W. Sterry,S. Philipp

The development of malignancies during therapy with biologics has been discussed controversially. A patient with extensive pityriasis rubra pilaris failed to respond to standard therapeutic approaches. While receiving immunomodulatory therapy, lastly with ustekinumab, the patient developed a CD30+ anaplastic large cell lymphoma.

 

[katiesue1506]

So A person developed this. One person that had an extensive cutaneous disease that also failed many other biologics... the last happening to be Stelara.

Lets not scare people here. Especially people like me who've failed most biologics and only have options like Stelara left.

We all know there are risks to biologics but those risks are just that. None of these drugs have 100% risk of causing lymphoma. There are also other risk factors that make you more susceptible to lymphomas (like being young and male). People who take biologics do so with the understanding of the risks and risk factors. These people are also under the care of doctors who feel the benefits of the drug outweigh the risks.

I also HIGHLY feel that the people developing these drugs are far from idiots. I'm pretty intelligent and I'd have no clue where to start on developing drugs. If you think you have better ideas then why don't you start developing? Start advocating... seriously... if you think you know all about Crohn's and treatments, why aren't you in the field? We need people who are smart and can fix us!


Edit: I had "everyone" in for "people" and forgot to change my word tense. Oh well.

 

[kiny]

People who takes biologics does so with the understanding of the risks and risk factors.

No they don't, how many know what happened in the trials of Tysabri?

I'm not trying to upset anyone with this post. But I am not the first or only one who said that this treatment could go wrong down the line. Stelara blocks specific interleukin that are responsible for T cell proliferation, it's going to go wrong in people, it's not a matter of if but when.

If posts like that upset people then don't visit this section of the site, I always will make posts like this.

As far as these people knowing what they're doing, people don't know half of what these IL do, and they're targeting them. No, they really don't know what they're doing at all, they are purely experiments.

 

[katiesue1506]

I personally understand what happened in Tysabri trials, however even though PML was a risk factor, it also wasn't a 100% risk factor. They have, since, redeveloped Tysabri not to cross the blood/brain barrier which is supposed to lower the risk of PML.

They are all trials and experiments... but its not as if they are uneducated experiments/trials. The only way to come up with new treatments is to test them... no one can develop a drug with no side effects because we simply can't predict the future. The only option to stop bad side effects is to never develop anything. Then we just sit here and suffer.

Your post does not upset me because I understand risk factors. But someone who is new and comes here a couple days after their first Stelara infusion might freak out to read this. That's all I was trying to say.

 

[kiny]

I understand, I also know it's hard decisions when people run out of treatments, I just want people to know those risks too because far too often that side of the coin is not shown. I post about the cancers and the worst case scenarios because I feel they need to be seen too.

Primum non nocere, first do no harm. If there is so much money involved I think many people don't respect this anymore.

 

[xmdmom]

I agree with kiny that risks are downplayed. There needs to be a place on the forum where risks and negative outcomes can be discussed, and perhaps another area where people who don't want to see/hear this info can go.

Primum non nocere was the first thing I learned in medical school, along with all drugs are toxic. That said, drugs with serious risks are sometimes lifesavers.

 

[Ya noy]

So A person developed this. One person that had an extensive cutaneous disease that also failed many other biologics... the last happening to be Stelara.

Lets not scare people here. Especially people like me who've failed most biologics and only have options like Stelara left.

We all know there are risks to biologics but those risks are just that. None of these drugs have 100% risk of causing lymphoma. There are also other risk factors that make you more susceptible to lymphomas (like being young and male). People who take biologics do so with the understanding of the risks and risk factors. These people are also under the care of doctors who feel the benefits of the drug outweigh the risks.

My husband's still recovering from the side effects of his blood pressure med, which resulted in potentially deadly form of Stevens-Johnson syndrome, called TEN, covering roughly 75% of his body with 2nd and 3rd degree burns, and which has a mortality rate somewhere between 30-70%.

If it had been listed as a potential side effects, he probably wouldn't have waited over 2 weeks before seeking medical treatment. At first he thought it was an allergy, then we thought it was shingles. When his temperature dropped to 92 degrees, and all the blisters and welts burst and his skin started turning black, and falling off in gigantic sheets, and his arms started swelling, we were afraid it was sepsis.

If you are one those who just happen to develop lymphoma, it will matter. Especially when you start reading about all the others, and realize it's no where near as rare as you were led to believe.

I also HIGHLY feel that the people developing these drugs are far from idiots.

That may be your opinion, but over 10,000 thalidomide babies born without arms, legs, and other severe deformities makes a rather effective counter argument. The 10,000 is only counting the babies that lived.

If you're not familiar with "Thalidomide" it was a drug developed for relieving the pain of morning sickness during pregnancy, and it worked too. The resulting birth defects were so severe, and heartbreaking, those victimized have still not recovered, and never will.

How about the deaths resulting from the brilliant idea of asbestos? Or from using coal as a home heating source? History is full of the deadly consequences of scientific advancements.

I'm pretty intelligent and I'd have no clue where to start on developing drugs. If you think you have better ideas then why don't you start developing?

Even if Kiny would go into the field, unless s/he happens to have been born in dependently wealthy, still wouldn't have any control, or much say regarding the type of drug that gets developed. Bringing a new drug to market is incredibly expensive, and for good reason. But that doesn't make it any less an issue of money and politics.

Start advocating... seriously... if you think you know all about Crohn's and treatments, why aren't you in the field?

In the future, s/he may very well end up doing just that.

 

[katiesue1506]

I don't think the resulting side effects from these drugs make the developers idiots.

History is full of the deadly consequences from scientific advancements but as I already stated the only option is to no longer develop anything new.

Scientists can not predict the future. The people who developed thalidomide and asbestos did not do it maliciously... these scientists aren't developing drugs FOR the bad side effects... not everything is a conspiracy.

You either forage ahead with the knowledge that bad things could happen or you do nothing.

So we do nothing then? That way no one ever gets hurt.

Basically my point is that its a double-edged sword... you can't have a perfect world. Bad and horrible things happen to everyone at sometime. All you can do is fix things with the knowledge you have because hindsight is 20/20.

 

[xmdmom]

Katiesue you are right that scientists can't predict the future but physicians should continuously assess new information which may change their decision making re: which drugs to use when. Unfortunately, there have been cases where drug manufacturers and medical device manufacturers knew of risks but didn't come clean until a lot of people were exposed to the risk and/or harmed.

example http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?_r=0
http://www.awkolaw.com/news/defective-drugs/diabetes-drug-maker-byetta-hid-heart-risk-from-fda/

 

[Ya noy]

katiesue,

Very little in life is that "black or white". If you expand your thought processes, you should be able to realize there are a number of alternative options and safeguards, many of which are now being employed. More than a few as a direct result of those Thalidomide babies.

Knowledge is power, and in order to make an informed decision, the ability to acknowledge, and openly discuss the potential risks and negative side effects, is every bit as important as the potential benefits.

If you find such discussions "scary", yes, but they are also necessary. The development of a healthy fear is actually an integral part of life--critical to survival. Without our "fight or flight" instincts, the human race would probably have died off long ago.

As far as "conspiracies" go? Maybe drug companies don't intentionally release drugs maliciously, but history is also filled with subsequent "cover ups"--To protect their own corporate interests. May not actually be malicious, but at minimum, cruel and indifferent. The actions of the tobacco industries alone are evidence of this.

You do realize that after 50 years of battling it out in court, the drug company responsible for Thalidomide has only recently settled the very first lawsuit--Leaving thousands of victims to struggle and die for over 50 years without the financial compensation that, at minimum, could have provided them with a more comfortable and humane "quality of life." The company didn't even issue an apology until just last year, which the remaining surviving victims are not accepting.

As far as "idiots" go? Well, I personally still want to slap the idiot(s) who developed nuclear weaponry. Sure, lots of good came out of that particular research, but it could also end all life on this planet as we know it. So which is the greater evil?

I agree that hindsight is 20/20, and yes, horrible things happen to us all, and are often beyond our knowledge or control.

but kiny was only seeking to provide information to assist others in making an informed decision. I feel you may be reading more into this than was intended.

 

[katiesue1506]

I agree these discussions need to be had and there should be a sharing of ALL information.

I just didn't like how the article was only about one case. I don't feel that people can base a decision on whether to take these meds based on an article about one person. I feel some who are not used to seeing articles or someone newly diagnosed who hasn't had a chance to get used to seeing medical jargon and risk numbers might take this article and use it as a basis for making treatment decisions.

Just as you said that companies are hiding information to protect their own interests, I don't think that's a clear picture either.

It may seem that I'm on the side of "big pharma"... I'm not. I'm actually not on either side. I do agree companies do things that aren't transparent. But I don't want the most horrible cases of everything to influence people either. I think you have to read all the information you can on BOTH sides and then make a decision.

PS. I agree about nuclear weapons But I can't say they are idiots. They are still smarter than I for even being able to make them. Just bad decision-making.

ETA:My idiot comment was resulting from a post that kiny had on here saying they were idiots, the post has since been deleted.

 

[xmdmom]

I know we are all on the side of wanting the best outcomes for people with Crohn's.

 

[Ya noy]

Yes, but also understand, that kiny was not posting a complete dissertation, but simply presenting information from one article, about one specific case. If you look at kiny's other posts, s/he presents information about all kinds of research, from wide variety of sources, and has demonstrated the same degree of skepticism towards the effective of so-called "natural" remedies, as pharmaceutics. I haven't noticed any bias either way.

There are geniuses and idiots in every profession. Those who are awarded Nobel prizes for literature are recognized as being every bit as brilliant in their field, as those who are awarded the same for their scientific advancements. And please don't imagine that just because someone happens to have an aptitude for chemistry, that somehow makes them "smarter" than you. It just makes them different, that's all.

In fact, it's known that a rather high percentage of the most brilliant individuals in history, are/were inflicted with: aspbergers, autism, OCD, ADD, bipolar, various addictions, and a wide variety of other disorders. Van Gogh was an alcoholic, Edgar Allen Poe was addicted to opium, while it is widely believed Einstein suffered from various disorders, including dyslexia and aspbergers. Thomas Edison, Winston Churchhill, Leonardo Di Vinci and William Shakespeare also all had learning disabilities. It is also believed that rather than a deterrent, these disabilities and disorders may have contributed to, or were even directly responsible for, the brilliance of their work.

So please don't sell yourself short. They probably aren't actually smarter, most of us just don't have enough "crazy" in us.

Oh, BTW, do you realize that the only reason Crohn's disease wasn't called Oppenheimer's or Ginzberg's disease is because the letter "c" happens to come before "g" and "o" in the alphabet?

See article:
http://www.cnn.com/2010/LIVING/02/17/mf.namesake.medical.condition/index.html