# Tofacitinib(xeljanz)



## Clash

Anyone heard of this? Saw a commercial for it to be used for RA and came across some info stating studies were underway for CD.

http://rheuminfo.com/medications/tofacitinib-xeljanz/tofactinib-xeljanz-detailed-information


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## nogutsnoglory

Never heard of it but glad to see another drug being studied for Crohn's.


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## Clash

We have a wiki entry on it but it basically says the same as the link I posted. I was wondering how far along they were with studies or if any of our members had been in a study. 

I think I'll see what I can dig up on the studies, if I find anything interesting I'll post.


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## Clash

Yikes, this article is a little concerning, although most the CD drugs come with black warning labels or certain risk factors

http://www.medicalnewstoday.com/articles/259752.php


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## 723crossroads

Clash said:


> Anyone heard of this? Saw a commercial for it to be used for RA and came across some info stating studies were underway for CD.
> 
> http://rheuminfo.com/medications/tofacitinib-xeljanz/tofactinib-xeljanz-detailed-information


wow, this sounds promising! Too bad I have had cancer or i would def. ask my Dr. for it to try.


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## mikyaragon

Hello,

I'm from Barcelona and I have Crohn's disease. Participate in a study of tofacitinib and me is working well. I'm in the third phase, the second was a placebo and not work for me. Now I am taking the correct dose.

My case was complicated because I worked infliximab, humira, ... I also did a treatment of dendritic cells and tried to make an autologous stem cells that could not do for my spinal problems.

We are very excited and hope to be approved for crohn in europe.

regards


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## nogutsnoglory

Glad to hear the medication is helping you. Hopefully it will be approved in the EU soon.


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## treypo9

mikyaragon said:


> Hello,
> 
> I'm from Barcelona and I have Crohn's disease. Participate in a study of tofacitinib and me is working well. I'm in the third phase, the second was a placebo and not work for me. Now I am taking the correct dose.
> 
> My case was complicated because I worked infliximab, humira, ... I also did a treatment of dendritic cells and tried to make an autologous stem cells that could not do for my spinal problems.
> 
> We are very excited and hope to be approved for crohn in europe.
> 
> regards



wow, that sounds awesome. is tofacitinib in a pill or injection form? Is there a pill form or other drug that comes in pill form that can be substituted for humira? thanks


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## seamus o'toole

In phase three. much improved. I am not happy about potential degradation of immune system but checking to see what I can do about that. The fact that it's an oral and not injectable is a plus. Smaller continuous doses. 

I was in the Trichuris suis ova (TSO), commonly known as pig whipworm eggs study which worked well for me. My understanding is they did not work as well as hoped so I am not sure when they may be approved by FDA. This is the direction I would prefer to go. :smile:

The first trial was for a herbal remedy from Japan which consisted of Ginger, Szechwan peppers and ginseng. Possible a little relief but not enough to be sure. 

I refuse to have surgery so I do meditation, control body Ph and do these studies. Diagnosed in 1997. 

Seamus


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## nogutsnoglory

Seamus have you been in remission since the TSO trial or do you feel subsequent doses would be needed?


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## seamus o'toole

remission (and it was) lasted about 30 days after my last dose. I was being re-dosed every two weeks as the "pig" worms can not reproduce in humans. They were hoping it might last longer or reset my system but the crohns was returning. At the 60 day mark I was able to start the test with Tofacitinib. I would not say I am in full remission but it is much improved and certainly manageable. I do hope to be able to go back to TSO if it becomes available. I can say the Tofacitinib also improves my arthritis which has been nice.


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## nogutsnoglory

I was very interested in TSO as well and interviewed for it but sadly the trial was a flop. Hopefully they continue to pursue it and see if there is any hope.


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## kiny

The only biologic that works for crohn's disease is infliximab (and it's derivatives). It's very unlikely to me that any other will ever work for crohn's disease, crohn's disease isn't an autoimmune disease in that it would regard tissue as a self-antigen, it's related to microbes.

There's a laundry list of biologics that they have tried for crohn's disease, the only one that worked is infliximab.

In an autoimmune disease, tissue is regarded as a self-antigen, in crohn's disease there is an immunodeficiency resulting in the inability to control and manage pathogens. Why would biologics that work for autoimmune disease work for crohn's disease, time and time again, biologics for crohn's disease fail.

Infliximab is from 15 years ago, since then, not one single biologic for crohn's disease has succeeded. (excluding derivatives)


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## seamus o'toole

I think we would all like to find that silver bullet that could allow us to lead lives without the company of our mutual friend. I also agree that crohns is more than an auto-immune disease. Unfortunately it may also be more than a single thing but rather symptoms of more than one "disease". The one thing I do know is uncontrolled inflammation is extremely dangerous and will in most cases cause damage that will require surgery or cause one to sustain damage that may not be reversible. That is my primary goal right now. Minimize inflammatory damage until we can get a better handle on specific treatments addressing cause and not just minimize effects. At my age natural deterioration is a concern so any other actions causing irreversible damage is high on my list of things to avoid. I am just trying to better the odds of me having something to save if a cure or cures be found. 

I am HLA B27 antigen positive and suffer from Ankylosing Spondylitis (AS) there seems to be a verifiable relationship between this genetic marker and several diseases (crohns). Causal or corollary I do not know but a useful clue I hope.

At 62 (birthday last Sunday) I am entering grad school and moving into a third career. If this takes me down before I can use this additional education I will to say the least be quite miffed. lol

To all be well, Seamus




I too was saddened by the apparent disappointment with TSO. It worked so well for me. I had been studying the relationship between parasites and certain diseases for the past few years and certainly looked forward to my involvement in the study. If nothing else it gave me six months of "normal" life and helped me reenergize.


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## worriedboy

Kiny - what about Humira ? We do see it has been a real success for many patients ...

plus, why does it matter if the inflammatory process is being driven by a persistent bacteria or another cause, as long as you are able to regulate the immune response to normal levels ? maybe Stelara can work after all ?

can you elaborate what you mean that Remicade is the one and only biologic for Crohn ?


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## kiny

worriedboy said:


> Kiny - what about Humira ? We do see it has been a real success for many patients ...


..



			
				kiny said:
			
		

> infliximab* (and it's derivatives)*


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## kiny

worriedboy said:


> plus, why does it matter if the inflammatory process is being driven by a persistent bacteria or another cause


because microbes are related to crohn's disease autophagy defects, lack of alpha-defensin from paneth cells, NOD2 and ATG16L1 for sensing bacteria and control of autophagy, inflammation of peyer's patches, macrophage deficiencies that line the intestine,....if you're unwilling to think about bacteria, then don't expect better treatment

have a hard time understanding your questions to be honest, are you not interested in the cause behind crohn's disease? I am

no one is saying you should care, you can not care also, but I have no idea why you're asking me these questions then

if you're asking me why I personally care, because I've had this disease for about 14 years now (I lost count)...since I was a kid, it's really hard not to care at this point

why does it matter if the sky is blue, some people want to know why, I don't question why they want to know, they just do, human curiosity


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## worriedboy

Thanks for your reply Kiny. I did not know Humira is a derivative of Remicade really (besides that they are both anti tnf-a) ... what else is considered a Remicade derivative ?

It was way off from what I meant, of course I do want to know the underlying cause, up till that day I think it all started to me because of a severe infection. I guess I am pre disposed and here we go ...

To make it clear what I meant about "care" is treatment-wise (just a poor figure of speach); while getting out the root cause is for sure the best treatment, this one is probably not yet available (as it would provide a sort of a cure ?).
In the meanwhile we are trying to keep the inflammation down. And what I was asking is why do you think there is no chance for other biologics than Remicade (and its derivatives) to work ?


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## kiny

worriedboy said:


> And what I was asking is why do you think there is no chance for other biologics than Remicade (and its derivatives) to work ?


Infliximab is special in that it causes apoptosis of specific activated immune cells (as in activated by the lymphatics through APC) by binding on the cell wall with TNF-alpha. Other immunosupressant biologics don't do that.

I think it has anti-microbial properties. Infliximab is counterindicated for TB, that's why you get that mantoux shot if you start it. But because people with crohn's disease have certain macrophage deficiencies, I think it's possible it's acting like an anti-microbial.

http://www.ncbi.nlm.nih.gov/pubmed/22398081

I think it is coincidence that infliximab works for crohn's disease. Lots of biologics were supposed to work for crohn's disease, based on the fact infliximab did, and they didn't.

Just the fact that most autoimmune diseases have a laundry list of biologics that work for them, they have literally dozens to choose from, and crohn's disease has 1 that works, and it was introduced 15 years ago. That should tell you there is more going on that simply suppressing the inflammation.

Things like vedoluzimab, if you have to use CDAI scores and only manage to put 6% of people into remssion versus controls....you're arguing that a biologic that has a worse remission rate than pentasa works....I don't think it actually works, there's a lot of ways to manipulate data.

I also think it's interesting that infliximab is slightly more effective than it's derivatives. Other immunosupressant biologics, from what I read, often barely manage to surpass placebo, you're arguing about single digit remission rates at that point, infliximab and it's derivatives have much higher remission rates.


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## kiny

Oh when I say biologic I mean immunosupressants that target cytokine / interleukin, the direct innate or adaptive immune response. I don't mean things like Qubiologics or molecules that can target biofilms or stuff like that.


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## seamus o'toole

Tofacitinib

Starting into week three on long term (30 weeks) phase. Have had a few bad days. I also have eye involvement with crohns and it has returned to some degree as well. I do have a history of my crohns getting worse in January. Most of my hospitalizations have been in January. After reading several discussion groups I have added (yesterday) vitamin D (5,000 IU)to my diet, any thoughts? Again it is not a severe situation at this point but concerning. I'll keep everyone updated on my Tofacitinib adventure. Good health to all. Jim


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## Essieluv

Personally, I am really excited that studies for new Crohn's medications and treatments are actually happening! Just the fact that people are trying to find better options for us is hopeful, even if it isn't always so successful at first. Although I do think that the Xeljanz study looks promising, because it is pill form instead of injection like other IBD medications. I think that there are way too few medication options for people with Crohn's disease and Ulcerative Colitis.


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## seamus o'toole

Health continued to decline during January. Got new round of meds. (Tofacitinib or placebo). Health improving again. Wish I was back on TSO. Microbial transplants seem to be showing great promise. If I can find a study I will try to get in it. I promise to report back. I am not happy about a course of medication that lowers your immune system. I just might need it for something else.


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## durwardian

kiny said:


> The only biologic that works for crohn's disease is infliximab (and it's derivatives). It's very unlikely to me that any other will ever work for crohn's disease, crohn's disease isn't an autoimmune disease in that it would regard tissue as a self-antigen, it's related to microbes.
> 
> There's a laundry list of biologics that they have tried for crohn's disease, the only one that worked is infliximab.
> 
> In an autoimmune disease, tissue is regarded as a self-antigen, in crohn's disease there is an immunodeficiency resulting in the inability to control and manage pathogens. Why would biologics that work for autoimmune disease work for crohn's disease, time and time again, biologics for crohn's disease fail.
> 
> Infliximab is from 15 years ago, since then, not one single biologic for crohn's disease has succeeded. (excluding derivatives)


Thus my point that a lot of people are being falsely diagnosed and treated with the wrong medications.


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## seamus o'toole

TSO worked for me, It protected me from inflammation and It worked more quickly and completely than anything in the last 18 years. The question is why didn't it work broadly enough to generate a successful study. It is available in Europe and I will consider it when current studies are over. 

Fecal (microbial implants) are working on more and more gut related issues. 95% remission (one year) in some and no serious side affects. It acts on the premise something was lost at some point due to illness or anti bacterial use. they are pinpointing which microbes do what and plan on using more of a strategic hit protocol rather than scatter shot. 

But right now I am on Tofacitinib and will report back to those interested.


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## seamus o'toole

TSO worked for me, It protected me from inflammation and It worked more quickly and completely than anything in the last 18 years. The question is why didn't it work broadly enough to generate a successful study. It is available in Europe and I will consider it when current studies are over. 

Fecal (microbial implants) are working on more and more gut related issues. 95% remission (one year) in some and no serious side affects. It acts on the premise something was lost at some point due to illness or anti bacterial use. they are pinpointing which microbes do what and plan on using more of a strategic hit protocol rather than scatter shot. 

But right now I am on Tofacitinib and will report back to those interested. The down side is so many of these medications are dangerous in their on right, choices, choices and cost (a med is worthless if you can't afford it), travel prohibitive. My hope is that one of these gives me time to be here when a cure might come as all but minor surgeries are a no go for me. Choices, choices. Reporting from the trenches.


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## Gmama

Good thought & prayers your way Seamus. You are paving the way for the rest of us!


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## seamus o'toole

No one should go through this. Hell I shouldn't go through this but I may have other family that is or will suffer from this. I also feel it is very important to put yourself into the fight if you are in a place to do it. My kids a grown, I'm divorced and still have a sense of adventure. There shouldn't be any young kids going through this. Teen years are hard enough and young adults should be on adventures of their own. Gives reason to something that has no reason. No guts no glory! no pun intended.


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## seamus o'toole

Health continued to decline through January so I well may have been on placebo for 30 days. Switched to "new" batch on Feb 6th and was very sick by that time. I have been improving slowly through the month so maybe I have now been on the medication or full dose anyway. I go to the doctor next Tuesday not sure if they change again or continue on what I am on now. Hopefully improvement will continue. Will check back in.


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## canope

I'm in a trial for tofacitinib. (I have ulcerative colitis.) I've gotten quickly and dramatically better, so I'm pretty sure I'm on the drug and not a placebo. The risk of intestinal perforation worries me. 

It also completely pisses me off that I can't titrate off the Prednisone until the 9-week induction period is over. I've gained significant weight, my gut is enormous, I have a hump on my neck, and I appear to be working on a beard - not a good look for a woman. I started off normal weight and reasonably attractive. Now I look like the fat lady in the circus. I actually took myself off the Prednisone shortly after I stopped bleeding, but my study doctor (who appears to have some anger management issues) went ballistic, so I'm back on it (Pfizer's condition for keeping me in the study).

I so deeply wish I hadn't been on Prednisone when I entered the trial, but I couldn't get off it. Every time I went below 20mg I started to flare worse.


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## seamus o'toole

Well am on my last 8 weeks. Improved the last three weeks. Had several kidney stones over the past three months. It always makes it difficult to figure out what is hurting and why until it starts passing. Anyway things were good till last night when I had a bad bleed but stopped before it knocked me off my feet so I made it to my appointment (I moved so it's a three hour drive now). Bleed not connected to meds so we move forward. If this continues to help I can be (might be) put on a long term study. High stress is a natural killer. I need to start to teaching meditation again, it's the only way I meditate regularly. lol  Prednisone is a no go for me. It turns me in to a person even the afore mentioned meditation can't help. I can take a bit in my IV when hospitalized but once I'm out the stuff nearly drove me insane. I sympathize with your desire to get off it. Well here is to success and eventually remedies that don't compromise everything else. Good luck canope be sure to share, so far it's been better for me as well.  (crohns)


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## canope

My study doctor said that after the 8-week induction period, I can continue on the drug as part of a 3-year maintenance study, if I want to. Are you in the Octave trial, too? The Octave study design says that you get re-randomized after the induction period, so people who had been on the drug and went into remission could get re-randomized off the drug and flare. This is why I wanted to get off the Prednisone NOW, while I'm quite sure I'm on the drug. But nooooo.

If I get re-randomized into a placebo group at the end of the 8-weeks and flare coming off the Prednisone, I then have to wait 6 more weeks before I can go into an open-label phase, where they give you the highest dose of the drug, no more fooling around. It's all very much centered on what helps Pfizer, not the patients in the study. The design is quite callous towards the welfare of the study participants. Still, the drug is helping me, and my doctor (the real one, not the bad-tempered study doctor) says it would cost $25,000/year to buy and I'm getting it for free. It's not a perfect situation, but it's better than the alternative!


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## seamus o'toole

Like you said we get to use drugs that we couldn't afford in most cases and get them sooner than available to others. Early Bird gets the worm but the second mouse gets the cheese. I'm hoping this is an Early Bird story and not a second mouse one. Also don't forget the big bucks you earn doing this.  But I guess enough of us are sick enough that we are willing to take the chance. I did really well on the TSO but I don't know what the plans are for future studies. As I understand the overall results we not what was hoped. Meditative forms really do help with stress, well Ativan does too but you build up a tolerance. Be well my friend.


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## canope

My poop has turned very yellow in the last couple of weeks. I just googled this, and it can mean an intestinal infection. I'm especially vulnerable to infection from tofacitinib because I'm also on prednisone, another immune suppressant. I'm a little scared. I'm going to call the study doctor in the morning.


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## seamus o'toole

I know you said you had a very "serious" doctor so I suppose you haven't added and vitamins or other supplements. Sometimes stool color will vary considerably depending on reaction to food. Dairy is a know culprit even if it gives you no other indications. Transit time. But an infection can be a factor so a check up is important. I have had several things pop up and was glad I had a gastroenterologist free of charge as I didn't have insurance. I am quite pleased with Doctors and nurses I work with. This is my third time up to bat with new studies. Sorry you have an additional stressor with your Doc. 

Be Well, Seamus (Jim)


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## canope

Actually, I'm taking 17 (sic) different supplements. I started these before entering the tofacitinib study. I'm also on a strict paleo diet.

I don't consider the study doctor to be my doctor, though I'm stuck with him taking care of me for the duration of the study. I really don't like him at all. I wish I was still under the care of my "real" doctor. On the other hand, the care is free when you're in a study, and I'm pretty broke right now. I had a colonoscopy at no charge, which was nice. I do have health insurance - I'd be dead if I didn't.

The yellow stool turned out to be from eating a lot of cashews. When you eat whole nuts, 20% of the fat is not absorbed. You get fatty stool. It took several hours of googling to figure this out.


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## seamus o'toole

Wonderful. Other than we who have severe intestinal problems would ever use colonoscopy and nice in the same sentence. lol I have been a vegetarian for 40 years so I just adjust amount of "roughage" as things go up and down. I have been on what I believe to be non placebo for almost 6 weeks and the results are very good after ups and downs. I want to get off of drugs that lower immune resistance but for the time being this is good times. Glad everything turned out on the infection worries. I have to do my nieces wedding this Sunday and there have been a ton of folks coming into town over the last week and I have been putting more than a few up, having four bedrooms is like having a pickup truck everyone want to borrow them/it lol. so If I get through this without a flair It will be a good test of efficacy.  Best of luck! Jim


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## seamus o'toole

My apologies for not reporting back sooner. I have been in two moves and now finally back home in Colorado. 

I was on the Xeljans long term study which is over now. The good news I had been in total remission from February 2014 until 8 weeks after discontinuation in July 2015. Got my life back for a time. I had forgotten what that was like.  Unfortunately it did affect my cholesterol numbers the last six months of the trial (160 to 390.) Well, first post drug flare third week in September. but cholesterol back to 160. So it works! It just causes cholesterol problems in some participants. I'm sure there are more side effects possible but total remission was achieved. 

I go in Thursday for a colonoscopy before starting new trials. I'll try to repost back in a more timely manner. 

Jim


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## canope

I went into remission quickly with tofacitinib. Then I was taken off the drug as part of the trial (after the initiation phase) and got very sick. When I got sick I was put on open label (no more double blind - highest dose of the real drug), but it was very difficult for me to get back into remission, and I was almost thrown out of the study. I barely got back into remission because you develop antibodies to biologics when you are taken off them. The study design was moronic and cruel. But I did manage to get back into remission and now I'm doing well again.

My cholesterol is fine. My only side effect is headaches. I have always been migraine-prone, and the tofacitinib makes them worse. I take a preventive med now and do some other preventive measures. It beats severe UC, however.


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