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Stelara stopped working

Hi. I have been on stelara for 2.5 years and it seems to have stopped working. Anyone have a similar experience? Theories as to why? I have already tried Entyvio and Humira with no success. Stelara was my dream drug. I was eating very liberally. Could that have made it stop working? Any ideas for next steps? So sad. Stelara was the only thing that worked for me.
 
I don't have a lot of experience with Stelara but pretty sure what you are eating didn't make it stop working. Most people have a limited time on a biologic. For some it is a year or two but others can go 10 or more. It is just a matter of time. My daughter responded beautifully to Remicade and then it just stopped. As her GI explained when you suppress one mechanism of inflammation sometimes other mechanisms upregulate. Sometimes it is a matter of the molecule they use to make the drug changing ever so slightly if the years.

As to what is next, I guess there is Remicade although if you already didn't respond to Humira I am guessing your GI may want to try something else first. Maybe Cimzia? I recently met a woman who ran through all drug options and was put on Tsyrabi even though most HOs have pretty much stopped using it due to PML risk. Her GI is a very prominent doc in the IBD world and he told her if she tested negative for the JC virus it was safer. Not sure how I feel about that but thought I would throw it out there.

I am sure your GI will have other suggestions, maybe adding something to Stelara such as methotrexate? Maybe there is something he could do with Stelara to recapture response.
 
I don’t know if you’ve already tried azathioprine or 6mp, they didn’t do anything for me but some people have years of remission on them. The anti map drugs (antibiotics) is an option but might be worth getting your blood tested first, which is easier said than done, there’s a place in New Zealand that say they can tell if you have it or not. I asked my consultant here in the UK what he thought of anti map and he got in touch with a colleague who has been prescribing it at St Guys (big London hospital), he said they save it for people who have run out of biological and they do get symptom relief for some patients. If you are in Canada the Qbecco people are still recruiting for their clinical trial into a new drug that looks quite hopeful, if you’re USA or Europe there’s talk of a trial next year.

Diet wise, some get remission some don’t, no one seems able to agree on what you’re supposed to eat and drink other than sugar and anything artificial bad, except of course the sugary chemical shakes, which put some people in remission! So who knows.

There are different views on the anti map. Some people describe lasting remission others nothing, and there are implications in terms of long term antibiotic use (resistance) and possible side effects (my consultant said this with a straight face while putting me on
Remicade). If I was out of biological options I’d probably fork out for the lab test to see if it was worth trying.

I don’t know if there’s an option of upping the stelara to try and string it out a bit longer?

I’ve read something about a new drug called filotignib or something like that that’s in trials but don’t know much about it.

Good luck and hope you can get settled again soon.
 

my little penguin

Moderator
Staff member
So Ds has been on Stelara for two years
Other options
Simponi
Remicade
Cimiza

Ilaris (some refractory case)
Ivig (some refractory cases)
New IL-23 drugs approved for psoriasis in process of approval for crohns (there are 2-3 of them )
Remember Stelara is il-12/I’ll-23
These are suppose to work better

Eli Lilly’s IL-23 inhibitor mirikizumab is trailing the field in lead indication psoriasis – where it looks set to be fifth to market – but could leapfrog some of its rivals in Crohn’s disease.

Lilly has just presented phase 2 results with mirikizumab in moderate to severe Crohn’s – a form of inflammatory bowel disease – which reveal significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo.

That included an endoscopic response rate of 43.8% for patients on a 1,000mg dose of the IL-23 antibody, compared to 10.9% of the placebo group. Other doses of mirikizumab – 200mg and 600mg – achieved endoscopic response rates of 25.8% and 37.5% respectively.

Similar benefits on endoscopic remission rates and patient-reported remissions, plus a fairly clean safety profile, have prompted Lilly to accelerate plans for a phase 3 trial in Crohn’s later this year. The data was presented at this week’s Digestive Disease Week (DDW) medical conference in San Diego.

Crohn’s could be an important indication for Lilly, as mirikizumab is very much playing catch-up in the IL-23 inhibitor category when it comes to psoriasis.

First to market was Johnson & Johnson’s dual IL-12/IL-23 inhibitor Stelara (ustekinumab) for psoriasis, which rapidly achieved blockbuster status with add-on indications in psoriatic arthritis and Crohn’s and made $4bn in sales last year.

Stelara has since been joined by J&J’s follow-up IL-23 inhibitor Tremfya (guselkumab), Sun Pharma’s Ilumya(tildrakizumab) and AbbVie/Boehringer Ingelheim’s Skyrizi (risankizumab), which are all already FDA-approved for psoriasis and require fewer injections than Stelara with safety and efficacy that is at least as good. Tremfya also has data suggesting it works in Stelara-resistant psoriasis.

Lilly’s antibody is still in phase 3 for psoriasis, well behind the leaders, but IBD presents a greater opportunity for the drug. With Stelara already available for Crohn’s, Lilly is hoping to be among the leaders to market in this indication, although as Tremfya and Skyrizi are already in phase 3 it will have to move quickly.

Mirikizumab is however already in three phase 3 ulcerative colitis trials that will start generating results next year, and has a chance of being first to market in this indication – although once again it is in a race with Skyrizi, which also has phase 3 trials ongoing in this setting.

"Following last year's presentation of positive phase 2 results for mirikizumab for the treatment of moderate- to severe ulcerative colitis, we are excited to return to DDW to present more positive data for mirikizumab in patients with chronic, inflammatory gastrointestinal conditions,” said Lilly’s head of immunology R&D Lotus Mallbris.

“As we continue to advance the science of gastroenterology, we are hopeful that mirikizumab helps us raise the standard and make remission possible for people living with immune-mediated diseases like Crohn's disease.”

From
 
Location
San Diego
Hi. I have been on stelara for 2.5 years and it seems to have stopped working. Anyone have a similar experience? Theories as to why? I have already tried Entyvio and Humira with no success. Stelara was my dream drug. I was eating very liberally. Could that have made it stop working? Any ideas for next steps? So sad. Stelara was the only thing that worked for me.

Don't give up on Stelara quite so fast. There are efforts your doc can try first to get Stelara working again. The standard approach is dose intensification - taking a bigger dose or more commonly shortening the time between doses.

You may be one of those who metabolizes the drug faster than usual. And/or you may have developed antibodies to Stelara that is inactivating the drug. Stelara is less immunogenic than the older drugs such as Remicade or Humira, but the rate of antibody development is not zero. Some people do develop drug-inactivating antibodies to Stelara. Again, the standard first step to battling antibodies is dose intensification. Has your doc tested your blood levels of the drug and the anti-drug antibodies? If not I recommend that in order to find out where you stand in that regard.
 

my little penguin

Moderator
Staff member
Forgot to ask what dose you are on ?
Standard is 90 mg every 8 weeks
But can be raised to 90 mg every 4 weeks.
Ds requires 90 mg every 4 weeks which works very well for his arthritis and crohns
 
Thank you so much for this information. It has taken my doctor forever to figure out what to do. I am waiting for an antibody test results. As we speak. Nobody has done an absorption test yet. I am going to see a Crohns specialist (vs a general gastro) at the end of the month and will ask him about that. I was under the impression that if you develop antibodies that you have to stop the medication. Game over. Sounds like I may have gotten that wrong. One thing I wonder is whether I ate too liberally and the stelara couldn’t keep up. Any thoughts? Thanks sooo much for any and all advice.
 
Location
San Diego
Thank you so much for this information. It has taken my doctor forever to figure out what to do. I am waiting for an antibody test results. As we speak. Nobody has done an absorption test yet. I am going to see a Crohns specialist (vs a general gastro) at the end of the month and will ask him about that. I was under the impression that if you develop antibodies that you have to stop the medication. Game over. Sounds like I may have gotten that wrong. One thing I wonder is whether I ate too liberally and the stelara couldn’t keep up. Any thoughts? Thanks sooo much for any and all advice.

I'm not sure there is a specific "absorption test." What I was referring to is that for some patients the drug level goes way down far more quickly than in most others, even though the patient may show no sign of developing antibodies. Thus they chalk it up to the body simply clearing or metabolizing the drug more quickly than usual. But they conclude this by eliminating other explanations, not be direct testing.

In any case, whether there are antibodies or no, the first approach is usually to up the dose - usually by shortening the interval from 8 weeks to 6 or 4 and see if that will restore remission.

Only after Stelara dose intensification, and then maybe dose intensification plus addition of an immunosuppressant, both fail is it time to think about switching to a different biologic.

As a general rule your first biologic works the best, so you should try to stick with it for as long as you can make it work.
 
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Generally when they run an antibodies test they will test the levels of the drug as well so you may be covered there. Antibodies don't always mean you have to stop. It depends on how high they are and if they can do something to stop them from getting higher. They often form because the drug level goes too low for too long. Increasing dose or shortening the interval can help with that.

It was not what you are eating. Food may cause symptoms but it does not cause a drug to not work.

Let me ask, do you feel better right after they shot and then start to feel progressively worse as time goes on? This type of affect is usually the dug working but clearing the body too quickly and an easy'ish fix. Depends on insurance and approvals etc.
 
Great, great, great. I have cut and pasted all of your ideas into a word document to bring with me to the LONG AWAITED meeting with the Crohns specialist. I just hope we haven't waited too long to increase the dosage. I am super grateful to everyone.
 
Generally when they run an antibodies test they will test the levels of the drug as well so you may be covered there. Antibodies don't always mean you have to stop. It depends on how high they are and if they can do something to stop them from getting higher. They often form because the drug level goes too low for too long. Increasing dose or shortening the interval can help with that.

It was not what you are eating. Food may cause symptoms but it does not cause a drug to not work.

Let me ask, do you feel better right after they shot and then start to feel progressively worse as time goes on? This type of affect is usually the dug working but clearing the body too quickly and an easy'ish fix. Depends on insurance and approvals etc.
I must admit I only feel slightly better in the first week after the drug and then I am struggling (frequent D, some pain). The only good thing is I don't have the crazy pain I had pre-Stelara, which required constant pain meds to manage. So...maybe it's doing something? I found what you said ("They often form because the drug level goes too low for too long. Increasing dose or shortening the interval can help with that.") very interesting and a bit worrying. My gastro mentioned the idea of increasing my dosage a year ago, but said she couldn't figure out if that was a thing and the insurance company wasn't getting back to her. My cynical guess is that she didn't really try very hard as that has been my experience with her (a sort of colonoscopy machine). Anyway, I fear that the year's delay in increasing the dosage allowed the development of too many antibodies. That is, it might be too late to restart/intensify the Stelara. I will know more once I get these test results back. And I know on some level there is no sense crying over spilt milk...and my theory may have no medical basis....but it has been a challenge finding doctors willing to really stay on top of this. Hopefully, the specialist in Denver will be better. October 21...hopefully a better doctor.
 
I'm not sure there is a specific "absorption test." What I was referring to is that for some patients the drug level goes way down far more quickly than in most others, even though the patient may show no sign of developing antibodies. Thus they chalk it up to the body simply clearing or metabolizing the drug more quickly than usual. But they conclude this by eliminating other explanations, not be direct testing.

In any case, whether there are antibodies or no, the first approach is usually to up the dose - usually by shortening the interval from 8 weeks to 6 or 4 and see if that will restore remission.

Only after Stelara dose intensification, and then maybe dose intensification plus addition of an immunosuppressant, both fail is it time to think about switching to a different biologic.

As a general rule your first biologic works the best, so you should try to stick with it for as long as you can make it work.
That makes a lot of sense. I was wondering about if there was another reason beyond the antibodies, such as the body clearing/metabolizing the drug more quickly for whatever reason. Thank you.
 
Another question is coming to mind: I was traveling abroad a week before I was due for my Stelara shot, which is when they wanted to test for antibodies. I had the test a week after I was due for my shot (I delayed the shot until right after the test). Do you think that two week difference could have affected the efficacy of the antibody test?
 
Location
San Diego
No. If anything the delay enhanced the chances of detecting any antibodies directed toward the drug. They try to time the testing for drug levels and for the presence of antibodies to occur just before the next scheduled shot - at the drug's lowest level: its "trough" (as opposed to its "peak" right after the shot.) Since the lower the drug level in the blood the less the drug will interfere with the detection and measurement of the antibodies that react with it.

However, what the one week delay may have affected is the measurement of the Stelara drug. The drug levels in the blood are the highest right after the shot and slowly decline over the 8 weeks until the next shot. One of the key measurements in determining whether or not you need dose intensification is how low the drug gets (the trough) just before the next shot. If the trough levels are high enough then drug intensification may not help so much. If the trough is low then maybe more drug is called for. What your measurement will show is the drug level with 9 weeks of decline instead of the standard 8. So the doc may need to sort of estimate what it probably was one week earlier. It's not a big problem - just a minor complication.
 
No. If anything the delay enhanced the chances of detecting any antibodies directed toward the drug. They try to time the testing for drug levels and for the presence of antibodies to occur just before the next scheduled shot - at the drug's lowest level: its "trough" (as opposed to its "peak" right after the shot.) Since the lower the drug level in the blood the less the drug will interfere with the detection and measurement of the antibodies that react with it.

However, what the one week delay may have affected is the measurement of the Stelara drug. The drug levels in the blood are the highest right after the shot and slowly decline over the 8 weeks until the next shot. One of the key measurements in determining whether or not you need dose intensification is how low the drug gets (the trough) just before the next shot. If the trough levels are high enough then drug intensification may not help so much. If the trough is low then maybe more drug is called for. What your measurement will show is the drug level with 9 weeks of decline instead of the standard 8. So the doc may need to sort of estimate what it probably was one week earlier. It's not a big problem - just a minor complication.
Ok. That makes sense. I will point that out to the specialist. Thanks again. Very helpful.
 
I don’t know if you’ve already tried azathioprine or 6mp, they didn’t do anything for me but some people have years of remission on them. The anti map drugs (antibiotics) is an option but might be worth getting your blood tested first, which is easier said than done, there’s a place in New Zealand that say they can tell if you have it or not. I asked my consultant here in the UK what he thought of anti map and he got in touch with a colleague who has been prescribing it at St Guys (big London hospital), he said they save it for people who have run out of biological and they do get symptom relief for some patients. If you are in Canada the Qbecco people are still recruiting for their clinical trial into a new drug that looks quite hopeful, if you’re USA or Europe there’s talk of a trial next year.

Diet wise, some get remission some don’t, no one seems able to agree on what you’re supposed to eat and drink other than sugar and anything artificial bad, except of course the sugary chemical shakes, which put some people in remission! So who knows.

There are different views on the anti map. Some people describe lasting remission others nothing, and there are implications in terms of long term antibiotic use (resistance) and possible side effects (my consultant said this with a straight face while putting me on
Remicade). If I was out of biological options I’d probably fork out for the lab test to see if it was worth trying.

I don’t know if there’s an option of upping the stelara to try and string it out a bit longer?

I’ve read something about a new drug called filotignib or something like that that’s in trials but don’t know much about it.

Good luck and hope you can get settled again soon.
Thank you. Lots of useful information and ideas. Great!
 
So Ds has been on Stelara for two years
Other options
Simponi
Remicade
Cimiza

Ilaris (some refractory case)
Ivig (some refractory cases)
New IL-23 drugs approved for psoriasis in process of approval for crohns (there are 2-3 of them )
Remember Stelara is il-12/I’ll-23
These are suppose to work better




From
This sounds very promising. I may an “IL”
Gal. I never responded in any real way to Humira or Entyvio.
 

my little penguin

Moderator
Staff member
My son has been on
Remicade (allergic reaction)
Humira (5 years)
Stelara (2 years so far )

Has not needed to try simponi or cimiza yet
 
Have your levels been tested and if you developed antibodies? I would test for that first. My son stopped responding after a year and levels were low with no antibodies so they increased dose to every 4 weeks. I have also heard of a re-loading dose and adding in methotrexate or other med to enhance Stelara's effect. We tried Thiopurine but it tanked my son's plateletes so had to stop it. He is going for a scope in a few minutes so we will see if Stelara every 4 weeks is doing to trick or if it is time to re-load or change as well. Either way for you, it is important to see your levels. It appears many with Crohns need it every 4 weeks.
 
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