Stelara Frequency

[Pilgrim]

Has anyone heard of dosing frequency of 2 or 3 weeks at 90mg? I've only been able to find a few case studies, just wondering if anyone has any info/experience.

Tagging @my little penguin from the kids forum but looking for any insight from the adults as well. Thanks

 

[my little penguin]

The highest dose we were told is every 4 weeks at 90 mg
Ds just saw his Gi yesterday
He stated they now know the majority of ibd kiddos are not held at every 8 weeks for Stelara and need. Every 4
Not sure where that leaves the more severe cases like your dd.

I would ask again about genetic studies suck childrebd hospital in Toronto should have something similar to chop /nih
Where they look at immundysregulation , immunodeficiency and other markers for veo ibd crohns
Since it’s tends to be resistant to traditional adult crohns meds

 

[Pilgrim]

H has had symptoms creeping back. Her calpro is around 1500. Being already at 90mg/4 week dosing Stelara the GI has opted to reinfuse. There is a little evidence for some success in adults, but not much yet for kids. It's relatively new as an option. So we'll see how it goes.

She will be infused with another loading dose and then go back into 4 week subQ dosing.

Let me know if anyone else has tried this yet and how it went.

 

[Pilgrim]

Can I move this thread to the Parents and kids forum?

 

[my little penguin]

Moved it for you

 

[my little penguin]

Ds has not tried the re infusion for Stelara
But so far every 4 weeks is working still for him (insurance battle yearly is another issue )
Hope the loading dose helps her

 

[Maya142]

I have heard of another kiddo who has done reinfusions twice and has done very well. In his case it was for arthritis and Crohn’s and vasculitis. However, in their case it was because insurance denied the 4 weekly frequency once and so his levels were 0 by the time it was approved. I’m not sure what happened the second time but I do know he started doing well again after having the infusion.

I really hope it works for H. Do you know if her levels are low by any chance?

 

[Maya142]

In terms of increasing the frequency, the max I’ve heard of is every 4 weeks because it’s incredibly expensive in the US.

 

[Pilgrim]

She did not get levels done. A year ago they were 11. But no idea of present levels.

 

[Pilgrim]

Waiting on GI to see what options we have and a timeline for how long to wait for the reinfusion to work. H had it a week ago but still going downhill. Fatigue and pain is consistent.

I wonder what the best choice would be after a failure of Humira and Stelara? If anyone wants to weigh in....

 

[my little penguin]

Because very little kids tend to fail normal pediatric therapies ….
Can you get a second opinion (online ) through children’s hospital of Philadelphia very early onset clinic ?
They take patients from across the globe and are one of the few places with a team (multiple specialists) who can focus on veo complicated cases

I know more than a few local parents who use their services but never actually travel there when things get tough .

they work with NIH database on just those special kids .

have they tried IL-1 meds ?
Some versions of little kiddie crohns are more auto inflammatory-less autoimmune
And respond well to IL-1 drugs like ilaris

others not do much
Some case studies used ivig infusions
Again limited studies
However if she is prone to migraines ivig can give aseptic meningitis-Ds had this

hugs

 

[Maya142]

Do patients on Stelara develop antibodies? I haven’t had a kid on Stelara so I don’t know.
But if it’s possible that she has, then Skyrizi is an option. Even if she’s just lost response without antibodies, it might still be a good option.

Remicade is also an option - both my daughters responded very well to Remicade after failing Humira. I know infusions are hard for you though. Would she be able to get them locally since she’s older now?

It’s possible you may have to combine two biologics since now she has small bowel disease too (if I’m remembering correctly) - there are studies combining Simponi and an IL-23 inhibitor (guselkumab) in adult patients with Crohn’s that are ongoing. The same combination worked well in adult UC patients.

There are also studies combining Stelara and Entyvio in adult patients I believe. @crohnsinct daughter combined Entyvio and Humira. Subcutaneous Entyvio injections have just been approved in the US - I am not sure if they are approved in Canada but if they are, that might make your life a lot easier.

You could also ask about a JAK inhibitor. Our (adult) GI said Rinvoq has done well in trials for Crohn’s and it’s approved in the US for adult Crohn’s, but I have heard of kids being on it. My daughter’s Crohn’s did very well on Rinvoq, her arthritis was the reason we discontinued it. It works pretty fast for Crohn’s too. It’s a daily pill, so as long as H can swallow pills, I think she’d enjoy the break from shots!

Xeljanz is another JAK inhibitor but it has been approved for pediatric arthritis so it has been tested on children. It is approved for UC in the US and not Crohn’s but according to M’s GI, she thinks that the trials for Crohn’s were poorly designed and she has used Xeljanz off-label for Crohn’s.

JAK inhibitors also work for psoriasis, which would be a plus. I know lots of kids with psoriatic arthritis or other subtypes of JIA who have done very well on them.

If it’s possible to do an online second opinion with the CHOP VEO IBD clinic, I would. They also have an immune dysregulation clinic which I REALLY wish my daughter could go to (though she’s much too old now). I am also wondering about IL-1 inhibitors for her arthritis, which is incredibly hard to treat and also started when she was very young.

Just remind me - when did she last have scopes? Given the new flare, it would make sense to do scopes to figure out where her inflammation is so that you can choose drugs that target the right area. There’s probably no point in trying Entyvio if her disease is only active in her small bowel, but it might be a great option if it’s only active in her colon.

 

[Pilgrim]

So right now we're waiting on a full array of labs, including checking for mineral and vitamin deficiencies etc. Our new GI is offering her the option of EEN or budesonide as a bridge. Originally offered Prednisone as the option but I brought up budesonide and she said based on last scopes we could try it. Scopes were a couple years back so we have limited info.
H doesn't have the will for EEN, though she has done it several times in the past. I respect that. She takes 3 shakes a day now to help manage symptoms.
Hopefully the budesonide will calm things down. I'm a Stelara fan and would love to keep it for longer. It's only been 2.5 years.
I've heard a lot of criticism (on this forum -adult side I think) about Skyrizi and not sure about JAK inhibitors yet. But we didn't go into next steps. We'll try to make her current med work.
I could find a VEO-IBD specialist at SickKids in Toronto but I would have to look into the second opinion process here in Canada. I don't think it's necessary yet.
Her inflammation is mostly small intestine I think based on her last few scopes plus symptoms. Entyvio is probably not a good option for her.

 

[my little penguin]

I can’t remember is she on methotrexate as well ?
Leufidomide (Arava ) is similar to methotrexate but can work when methotrexate isn’t tolerated. My dh switched (SpA and arthritis in hands etc..)
From methotrexate to Arava
He said no real side effects and likes it much better.
don’t blame her on the een
Mine was the same way did een a few times when he was very little but around 12-14 just couldn’t bear the thought of it yet again .

hope the steriods help
Ds loves Stelara still after 6 years
Insurance fight is on going to keep him on the dose frequency he needs but otherwise all good

 

[Maya142]

If her scopes were a few years ago, it really may be worth redoing them to figure out where the inflammation is. It is a big factor in figuring out what the next drug would be (though I know you say you don’t want to switch…but you never know. My kiddo with stubborn disease generally lasts 2 years on a new biologic and no longer. She lasted 4 years on Cimzia but that was the longest and she’s been on 10 biologics at least).

Arava or Leflunomide is great for peripheral arthritis but I’ve never ever heard of it used for IBD. There is also limited info on whether it works the same way as MTX and whether it prevents antibodies from forming and increases trough levels of the biologic you’re on. There just haven’t been enough studies. But we have used it for that purpose for M when she couldn’t tolerate MTX.

I do also still think testing for antibodies might be useful. If she does have high levels of antibodies, sometimes they can use that to get a higher than normal dose of a biologic justified. Or a more frequent dose justified.

I can understand how hard EEN is at her age. She was such a trooper for doing it for so long!! Was she ever offered the option of 80% EN and 20% food? My daughter thought that was MUCH easier than 100% formula and also thought inserting her own NG tube and doing feeds at night was way better than drinking shakes.

I have heard good things about Skyrizi from one parent whose kiddo (now 15) has small bowel Crohn’s. He has no disease at all in his colon. But really that’s all I know.

Is Remicade an option, given that she responded to Humira for so long? Can she have infusions close to home now?

I hope Entocort gets her feeling better SOON!

 

[my little penguin]

Abstract
Background: Immunomodulator therapy with the purine analogs azathioprine and 6-mercaptopurine (6-MP), is efficacious in the treatment of moderate to severe Crohn's disease (CD), but is not tolerated by a significant minority of patients. The pyrimidine analog, leflunomide, has demonstrated efficacy in the treatment of rheumatoid arthritis (RA) patients. Because established RA immunomodulator agents may demonstrate success in the treatment of CD, we reviewed our clinical open-label experience with leflunomide in a refractory CD population. GOALS Assess the effect of leflunomide 20 mg daily, on disease activity, steroid requirement and serologic measures of inflammatory activity in our series of CD patients intolerant to azathioprine/6-MP.
Study: CD patients intolerant of azathioprine/6-MP were offered leflunomide treatment. The Harvey-Bradshaw (H-B) disease activity index, global assessment, serologic parameters and ability to taper corticosteroids of those who accepted were retrospectively assessed.
Results: Leflunomide was well tolerated and resulted in a significant reduction in the H-B score, global assessment and serologic parameters in 8/12 patients. Average follow-up was 38 weeks and a majority of steroid-dependent patients were able to successfully taper following leflunomide initiation.
Conclusions: Our case series demonstrates that the pyrimidine analog leflunomide may be effective for treating moderate to severe CD patients intolerant to standard immunomodulator therapy and warrants further investigation in a randomized controlled trial.

From

Leflunomide treatment of Crohn's disease patients intolerant to standard immunomodulator therapy - PubMed

Our case series demonstrates that the pyrimidine analog leflunomide may be effective for treating moderate to severe CD patients intolerant to standard immunomodulator therapy and warrants further investigation in a randomized controlled trial.

pubmed.ncbi.nlm.nih.gov

.

it’s been used in crohns

 

[Maya142]

That is very interesting MLP! But is it actually being used beyond by GIs small studies? It seems like it’s just being investigated from the study you posted.

I also wanted to add, I know H had a bad experience with MTX last time. So did M when she was on it as a teenager. We tried every trick in the book - switching from pills to shots, doubling folic acid, adding Leucovorin (folinic acid), lowering the MTX dose, Zofran, granisetron, giving it at night etc. and nothing worked at all. It ruined her entire weekend - she had terrible nausea, would vomit (not always but sometimes) and struggled with fatigue and dizziness which was so bad that she spent the whole weekend in bed. It made her so miserable, she got anxious if you even mentioned the word MTX before we finally stopped it.

We even tried anti-anxiety medication to see if she was get anxious and then VERY nauseous and dizzy from the anxiety. That didn’t help at all - instead of just being nauseous, she was very sleepy too! We tried it 3 or 4 separate times with different doses - 25 mg, 15 mg, 10 mg and 7.5 mg (I think…it’s been a while!).

Anyway, she retried MTX as a young adult. I expected it to fail miserably but she has (thankfully) done well. And by well, I mean she’s been on it for 3 years now without any side effects!! In the beginning she used to take Zofran before MTX because she was nervous about getting nauseous. Now she doesn’t even bother with that. She gives herself the injection - 15 mg weekly. No side effects except mild hair loss. NO nausea at all!!

So if H is willing, you could consider trying again. It might help give Stelara the boost it needs!

 

[Pilgrim]

Thanks @Maya142 ! That is a very positive anecdote. This forum is so great because it is both the research and the personal experience that people offer that help us roll around options.
H was much the same although we mostly dealt with injections due to her GI preference. It was 4-6 weeks of ruined weekends with nausea and vomiting and then when her body adjusted we would have just severe fatigue.
We'll see how the steroids work and I'll put that long term idea in my back pocket!

 

[Pilgrim]

@my little penguin Lefluminide is another idea! H had pancreatitis from AZATHIOPRINE years ago. I will keep my eyes open for more info on the drug in the near future.

 

[Maya142]

Both my daughters did well on Leflunomide - no really significant side effects. However, if you look at the possible side effects it does list many of the same ones as MTX - nausea, vomiting, hair loss, loss of appetite, diarrhea etc. But anecdotally, I have heard from numerous parents of kids with JIA that their kids who were miserable on MTX did very well on Leflunomide. In the JIA world, for many kids, it's an incredible relief to find a med like MTX without the side effects.

I will say that M lost weight on it the first time she tried it. And she actually did lose significantly more hair on it than on MTX, which surprised me (but she was also malnourished at the time, so that may be why). But no nausea or vomiting so for many years she was on that instead of MTX. She was absolutely thrilled to be on it considering how awful she felt on MTX when she was younger.

For both my daughters' joints MTX does work better. But Leflunomide did work pretty well too and it's possible it'll be an option in the future