If small bowel and colonic activity - is Entyvio a good choice?

[nelsonshan]

Hi -
My son has already failed Remicade, Humira, and Stelara. They are looking at Entyvio as a possible option. First we are doing EEN, budesonide, and my hope is that he'll go into remission and we can continue on with Stelara. Should that fail, they are considering entyvio +- diverting ileostomy.

My question is with everything that I"m reading, Entyvio appears to work best in the colon. But my son has active disease at the terminal ileum and cecum mainly. So what happens to his small intestine if we do Entyvio?

We are planning on scopes in July after EEN. He did have an MRE. The last 4-5cm of terminal ileum are bad, so they are saying they could go just up from that for the ileostomy. We'd like to avoid that if possible. But not sure the Entyvio alone will do it.

Seems like the best bet would be Stelara with Entyvio, but I'm sure insurance won't go for that.

Does anyone know if there's success with Entyvio in the small bowel/stomach area??

Thanks!

 

[my little penguin]

Tagging @crohnsinct

 

[crohnsinct]

Hey there! Back in the parents section I was asking where majority of his disease is. So it is small bowel. And he is on Stelara now? How long has he been on it? I ask because it is a very slow action drug but it does have much better success rate in small bowel than in colon. Entyvio has better success in colon than small bowel.



O has disease in T.I. and colon but her colonic disease is the real drama queen. The small bowel is a supporting actress. They are having trouble finding a drug that will treat both areas. But since it is her colon that is refractory to all drugs and we haven’t tried Stelara yet they are talking about colectomy to get rid of the problem child and then hopefully treat TI by continuing with Humira or switching to Stelara.

Sorry I know this isn’t helping other than to say you are not alone.

So back to your question Entyvio is not known for it’s success with the small bowel although it does sometimes work. I think it’s success with the colon is even pretty low at like 40%.

O got two biologics approved. She is on Entyvio for her colon and Humira for her small bowel. It helps if one is infusion and one is injection because then one goes through pharmacy benefits and one through medical.

Neither drug is working for O right now and we are also thinking of doing a round of EEN to heal things up and then see if Humira can take over from there. We had to do this years ago with Remicade. It just couldn’t take on her disease burden but once we healed things with EEN, Remicade worked like a charm.

 

[crohnsinct]

I don’t know a lot about T.I. surgery but I am wondering why they can’t remove the damaged portion of the TI and then connect the healthy part to the colon. Is this a permanent diversion or are the hoping temporary to rest the colon and then reconnect later.

I know you are at the beginning of these discussions and your head is probably spinning and you may not have all the answers just yet.

I know in general we parents here tell others to make sure we see pediatric docs and I totally agree with that but when it comes to surgery and especially more advanced IBD surgery there are fewer pediatric surgeons who specialize in bowel surgery. I have been encouraged by our old GI to get three opinions before doing any surgery and he suggested we go to a well established adult center where they have dedicated IBD surgeons as they have seen a lot more cases and might come up with an option the pediatric docs might not have thought of. A little easier for us with O as she is 20 but I would still recommend it to anyone. I am even hoping the adult GI’s at one of these centers might have a suggestion med wise. For instance a lot of them are using tofacitinib now and I am wondering if this might be an option for O. Pediatric GI’s are starting to use it now also. Not sure how I feel about it but I would at least like to hear more about it.

you might also ask about getting a second opinion at a pediatric IBD center that has a lot of experience with surgeries (if your center doesn’t). We are at a pretty major hospital and I was surprised at how few surgeries they do there and will be seriously considering the benefit of staying at a hospital she is familiar and comfortable with vs going to a major center that might require a flight and staying out of town for a while.

 

[my little penguin]

If surgery is on the table children’s hospital of Cincinnati has one of the best colorectal surgeons in the world not just US
Treats adults and kids
Prior to d of crohns they were looking at rectal surgery for ds and this doc was the best of the best
Good luck

 

[Delta_hippo]

Sorry to hear what you’re little one is going through. I have been in entyvio for a year (I’m an adult) for aggressive Crohn’s that started in small intestine but moved on to large within months. It has kept systemic inflammation under control (taking over from remicade which I couldn’t tolerate) but has struggled to get intestinal inflammation as measured by faecal cal protection to anything near normal. I also had an endoscopy after six months on entyvio which showed mild issues in stomach which they said was gastritis and as I don’t drink, take cocaine, antibiotics or nsaids is possibly the Crohn’s.
So I can’t give you a ringing endorsement for the entyvio, on the positive side it’s much nicer in terms of side effects and seems very low risk around Coronavirus. If you go for it I would recommend keeping an eye on the FCP which is easy as stool test not intrusive.
Good luck

 

[nelsonshan]

What are the thoughts on using Entyvio with immunomodulators? Does Entyvio carry a risk of antibody formation that azathioprine could help with?

 

[my little penguin]

They don’t recommend aza anymore in kids especially males with biologics
The preferred med is methotrexate
Tagging @crohnsinct
To cover both areas small intestine and colon -two biologics were used

 

[crohnsinct]

Hey there! Yes you could use Entyvio and Stelara. We are using Entyvio and Humira and the GI's I follow on so me often use Entyvio with another biologic so it can be done and be successful and does get approved. Especially if you are trying to heal the two different areas.

I know Entyvio is not the go to med for the small bowel but O had disease in her T.I. and colon and she just had her colonoscopy and it seems Entyvio healed her T.I. and a bunch of her colon. It can and does work, it is just a crap shoot (forgive the pun). Now she did recently add Humira so maybe the Humira healed the small bowel but it was so recently added, I don't think that was the agent, I really think it was the Entyvio.

Entyvio is still pretty new so they don't know as much about it as the anti tnfs but they don't think there is the same issue with antibody formation so they don't "need" to use immunomodulators as much.

Entyvio takes FOREVER to work. Similar to Stelara. You will need bridge therapy. What we have found is if you can heal the bowel with EEN or at least tame the inflammation with steroids then the new med has a better shot at working.

 

[crohnsinct]

Where is he with his EEN cycle? How did the budesonide do?

Maybe you can wait and see how that and Entyvio do and then look at the T.I. and colon. If T.I. is still a problem then maybe surgery becomes a resection rather than an ileostomy? Have they said why they are considering an stony if his primary problem is the T.I.?

 

[nelsonshan]

He's on week 13 of EEN and scopes are tomorrow. While his CRP and Sed rate have decreased, his calprotectin has increased to 750 now. We are anxious to see how the scopes look. We did the budesonide for a month and it seemed to help with his symptoms. They didn't want to keep him on it too long, since they wanted to see how the EEN did. He's had some instances of stomach pain, but overall I think he's felt well on it. Just don't like that the calprotectin has increased, since that seems to coorelate best with his disease activity.

If still lots of active inflammation, they are thinking about trying the Entyvio with or without a diverting ileostomy. I asked about removing the portion that's bad around the terminal ileum, and they said they like to do DI first since the surgery can lead to scar tissue, etc..

Seeing has how we just did the EEN, would you think steroids would be the next bridge? Or hoping things look good enough to continue the Stelara perhaps with partial EEN?

I know the recommendation varies between institutions whether they give Imuran or MTX, and we are comfortable with the Imuran. I'm just asking if it would decrease chance of antibody formation with Entyvio if we kept it on, or if we should just drop it.

 

[crohnsinct]

Hmmmm that's not super encouraging. I mean great that the CRP and sed rate came down but an increasing cal pro is never encouraging. Let's cross fingers for a blip. Perhaps the stomach pain and increased cal pro were from a little stomach bug? Grasping at straws here.

Yes, I think steroids would be the next bridge. Or Tacrolimus but not a lot of pediatric GI's use that. You could also go back on the budesonide or keep EEN. This is where medicine really becomes art more than science.

If you and your GI are comfortable with Imuran then you could also use that while you wait the 26 or so weeks for the Entyvio to fully kick in.

Sorry to be so dense but where is the bigger problem area? His colon or TI? Just curious because if TI how does an ileostomy help it heal? Totally get the temporary diversion for colonic disease.

Anxious to hear how the colonoscopy goes. GOOD LUCK!

 

[my little penguin]

@crohnsinct
wasnt she on humira for more than a few weeks prior to the good scope /healed ti with entyvio ?

 

[crohnsinct]

It was 6 weeks after starting so maybe three doses.

 

[nelsonshan]

So, overall there was still a lot of active inflammation. His stomach and first part of duodenum were moderately inflamed with edema, erosions and erythema. This is where he was worst 5 years ago. It had since improved quite a bit, but now is back to this. There was barely any problem with these areas a year ago. So perhaps the Humira was helping that part??

His TI was only mild inflammation and erythema - this is improved from a year ago. So maybe the Stelara did help with this part?

His cecum, recto-sigmoid colon, and rectum are roughly the same from a year ago with moderate edema, erythema, and apthous ulcerations.

So, the EEN wasn't enough. The Stelara isn't enough.

She wants to wait for biopsies and confer with colleagues for next steps. Possibly Entyvio alone; Entyvio with Humira; Humira with Stelara; Not sure insurance will go for 2 biologics. Considering removing Imuran if going on Entyvio alone, since there is very low risk of antibody formation. Considering steroids as a bridge, but sometimes they use no bridge she said? We are going to taper EEN, but still stay on 1-2 boxes daily for nutritional support. She know we really want to avoid any sort of ostomy, so will most likely try these other options before going to that.

Any thoughts?

 

[crohnsinct]

I would not want to move to Entyvio without some sort of bridge therapy. Remember what happened to O last year and she had a bridge therapy! Entyvio is extremely slow to get to therapeutic levels (26+ weeks) and with existing inflammation you might be opening the door to a massive flare.

I also wouldn't just drop EEN. That never goes well. A very slow reintroduction of food is best. If you are going to do that and he is already on full EEN maybe consider the Crohn's Disease Exclusion Diet. It is showing some really good results with inducing remission. You would drop down to 50% of calories from formula and for six weeks eat food from the mandatory list (chicken, eggs, potatoes and apples (peeled) and some allowed foods (rice, limited fruits and veg). After 6 weeks of that the diet drops down to 25% formula and the diet gets expanded.

The key is no dairy (except at a certain point you get to add 1 serving of plain yogurt a day...could be SCD yogurt. No processed foods, no red meat (although in phase 3 you can have that once a week) and no gluten (in Phase 2 you get to have 1 slice of whole grain bread a day and phase 3 two slices. In phase three yogurt 4 cheat meals a week.

Other than diet and EEN as bridge, I would go with steroids or tacrolimus.

I think I would definitely go with Entyvio for the colon but would want another agent onboard for the small bowel. How did Humira do for his T.I.? The duodenum is notoriously hard to treat (like the rectum) so I might go with whichever drug got that under control.

Also, as insurance approvals go it is easier to get one biologic that is infusion and one that is injectable covered. This way one goes to the medical side of your insurance and the other through pharmacy. it isn't like you are cheating the system as you aren't trying to hide anything but the two sides don't always talk.

So it sounds like they are considering the ostomy for the colon. Would they be removing anything or just doing a temporary diversion? We are learning that temporary diversions are pretty effective in kids, especially if the disease is moderate. But you do still have options and sounds like the GI is really wanting to honor your wishes to exhaust all pharmaceutical options first.

Good luck with the decision. Keep us posted!

 

[nelsonshan]

I wish we could go to CDED or SCD, but my son is super picky. Last night, we asked him to try rice, and it took him 20 mintues to be able to eat a little spec. He wouldn't try potato. It's easier to do EEN for him that any sort of food diet. We will continue on the 2 boxes formula daily for nutritional support.

Spoke to his dr today. The biopsies confirm active disease in the stomach, duodenum, TI, cecum, recto-sigmoid colon, rectum.

She is thinking about using Entyvio with Humira (if he hasn't formed antibodies to it). She thinks this is the safest, least risk scenario. She thinks Humira+Stelara is more immune suppressing. She also thinks that if we do add Humira, we should change imuran to MTX.
Other options would be Entyvio alone, just change Imuran to MTX, Stelara+Humira; She said with 3 meds, she would add Bactrim 3 times weekly to prevent lung infections.

First step we will go for labwork to check Humira level/antibodies.

Any thoughts?

 

[my little penguin]

Stelara has very low risk of infection per infectious disease doc we saw
ID doc said humira was much higher risk infection wise

As far as diet to help
Picky kids know /learn they can get the types of food they want
You have to treat it like medicine
Ds has had life threatening food allergies since age 4
So being told this is what you have for dinner was something learned

So for cded
You need to involve the kiddo in the planning
Here is the list of foods you get to pick from
Want to help come up with recipes to try
So they are in control
They can have any food they want
But from the list try new things they are interested in ...
New foods are better than trying to sub out old foods
Some foods he may not just like
Rice is not on cded btw

We made things like
Omeletes in a Belgium waffle maker
Using safe listed add ins
Eggs tomatoes onions or potatoes

There is also the anti inflammatory diet from chop
Less restrictive

https://media.chop.edu/data/files/pdfs/anti-inflammatory-diet-pfe.pdf
My point it needs to be treated like medicine
Especially if you are having to double up on biolgics to get things under control

 

[crohnsinct]

You can do stelara with Entyvio with no problem. Plus that combo is very low risk of infections How long has he been on stelara? He may need more time on it but I agree now might be the time to add entyvio.

As far as diet goes, if you open his diet immediately you are inviting inflammation as EEN is good at inducing remission but once you come off inflammation returns so you will undo all that hard work. You have to add foods VERY slowly.

CDED does allow rice but it isn’t a necessity. If he is facing colectomy now might be the time to have the GI/psych explain that options are limited and diet may help him avoid the surgery. Not in a threatening, scary way because you don’t want to deamonize surgery but just so he can make an educated decision. Also, I would try to get an occupational therapist or speech therapist and dietician on board to help broaden his diet even if you don’t do CDEDor SCD etc.

Good luck! I hope he doesn’t have any antibodies and that the combo works for him.

 

[nelsonshan]

We have seen occupational therapy before for his food aversions. After several thousands of dollars and much frustration later, the only progress we made was touching his tongue to bread and a green bean a few times. It's truly something mental for him that he would rather go to bed hungry than try a new food. He's never had eggs, potatoes, chicken, steak, fish, spaghetti, pizza, hamburger, etc.. and he won't even try it. It's been a long road of trying everything and it just doesn't work. He literally only eats mac n cheese and chicken nuggets. He does like cheese, apples, strawberries, cucumbers, carrots. So it's not all bad, but very limited. We have tried everything and get much judgement from all over for not "making" him eat certain things. In the past we have literally put things down his throat and he's thrown them up, so that doesn't work either. He's more than likely had Crohns from the beginning and has had a fear of food hurting him. Everyone seems to think he'll "outgrow" it, but he's 11 now, and no change! I take that back - he does like pancakes now, which was a big win!

It's just that there is almost no improvement with the Stelara from scopes 5/2019. If anything, maybe a slight improvement in the TI. But cecum, recto-sigmoid colon is the same and the stomach/duodenum are much worse now. At least the stomach/duodenum seemed to be controlled with Humira, so that's why they are thinking that.

 

[my little penguin]

How were his upper scopes ?
Did they rule out eosinophilic diseases ?
I only ask because most kids with EoE go to the extreme of your kiddo on food aversion because food hurts and makes them sick
Cincinnati used to be the top place in the country for that

food aversion to that extreme is very different than a picky child who decides not to eat broccoli

since that’s the case will your go let him stay on 80/20
80 % formula (since he is drinking it )
And 20% solid food of whatever he will eat
Until his symptoms are more stable
Especially given his limited diet

if there was not improvement on Stelara then
Definitely switch it up with a different combo
Entyvio /humira
Did they test for anything out of the ordinary ?
Maybe a JAK inhibitor ?

that’s one is tough

 

[nelsonshan]

His upper scopes showed active inflammation in the stomach and duodenum, but esophagus was ok. If 13 weeks of EEN did nothing, I don't really see the point of it - we plan to stay on a couple boxes a day for nutritional support, but might as well let him eat if he wants to.
They are working on insurance approval now for Entyvio and Humira. We went to the lab today. Fingers crossed he doesn't have antibodies to it!!

 

[crohnsinct]

I thought the EEN helped with the TI as it was improved with this scope. Of course that could have been the Stelara but I would want to keep EEN and very slowly reintroduce foods just in case the EEN was the helper here.

EEN doesn’t usually have a goid success rate with the colon so no surprise there.

It’s hard trying to control the two different areas when the couple of drugs that handle both areas have been tried and failed.

I forget. Was there any discussion of antibiotics for the colon. There are various options out there. O is on her 5th combo now. It might be a goid option if he can’t go back in Humira due to antibodies.

Another thing we considered with O was a g tube for tube feeds if we did long term formula therapy for her disease.

Not trying to pressure you at all but OT’s are just one specialty that deals with eating issues. Speech pathologists are trained as much if not more with food issues and psychology can help. I know how difficult it is and it often takes a team approach. Might be something to revisit when the time is right, Especially since the foods he likes are in the pro inflammatory category.

Hugs!

 

[nelsonshan]

His dr thought his TI looked better on scope, but according to pathology, it's active inflammation. Here is his path report:

Diagnosis:
A. Distal esophagus, biopsy: No specific pathologic change.

B. Gastric antrum and body, biopsy: Patchy chronic active gastritis.

C. Duodenum and duodenal bulb, biopsy: Focal chronic duodenitis.

D. Terminal ileum, biopsy: Active chronic ileitis. No granulomas seen.

E. Cecum, biopsy: Diffuse active chronic colitis with focal ulceration.

F-I. Colon, ascending, transverse, descending, and sigmoid, biopsies:
Patchy mild lamina propria chronic inflammation.

J. Rectum, biopsy: Mild chronic colitis with focal activity.

I got a message from his dr today that no Humira antibodies showed up on the blood test - yay!! But insurance did deny the PA on it. She's fighting that and working on Entyvio as well. Just a waiting game now.

 

[nelsonshan]

Hi all -
Our first Entyvio infusion is on Wednesday. Still trying to get the Humira approved.

We stopped Imuran a couple weeks ago. We are going to be starting Methotrexate if he goes on the Humira to prevent antibody formation. She's thinking 20mg (0.8ml of the injection). Does this sound like a reasonable dose? She didn't mention Folic Acid with this, but he should also be on that, right?

I'm getting nervous with the new meds coming up! I feel good about this treatment plan though. With so many areas affected, hopefully this combo will work.

 

[my little penguin]

What bridge therapy until entyvio kicks in ?
It can be 8 months average .
Mtx can be given by injection or pills
Stand alone therapy is Injection up to 25 mg max
Pills are also up to 25 mg max
Some kids get less side effects (flu like and nausea ) from mtx depending on the form

Ds can not take injection mtx -makes him feel horrid for 5 out of 7 days a week regardless of dose or folic acid
He currently takes 20 mg once a week and has for a few years (but for arthritis -Stelara works better for arthritis when mtx is added )

 

[nelsonshan]

No bridge - hoping to get Humira on board quickly. EEN didn't work for him. Would like to avoid prednisone if going to be on all 3 of Entyvio/Humira/Mtx, as he'll already be rather immunocompromised, especially with the pandemic.
I was worried that 20mg might be too much, but seems reasonable then??
I also take MTX 25mg weekly for RA, with folic acid. I thought folic acid was a requirement to be on MTX. I have found that the injection causes less nausea/brain fog/headache, etc.. than the tabs, so I requested the same for him.

 

[crohnsinct]

He definitely needs the folic acid. I would ask specifically about that, she may have just forgotten to mention it.

It generally takes Mtx 12 weeks to reach a good therapeutic level. Entyvio takes at least 12 weeks but generally is more like 24 weeks and more. Humira can show some benefit early on but again takes at least 8-12weeks. Perhaps they feel like he will have some residual benefit from the Imuran but given our experience cutting over to Entyvio AND with Tacro as a bridge she still ended up in the hospital for most of the summer.

I would ask for frequent labs including cal pro just to keep an eye on things, especially since he is already inflamed.