Moving on to Stelara

Hey guys. I decided to start a new thread since C is starting a new med.

So, to recap
C's scope looked bad- inflammation from surgical site and throughout colon with granulomas and mini ganulomas (yeah that's a new one for me).

At the follow up I asked if instead of moving to entyvio was there anyway C could get the dose schedule(higher dose than what's on the market now) of stelara that is in phase III trials and showing some good results. It's also in phase III trials for SpA which is why I hoped we could get it instead of entyvio which GI specific and doesn't treat SpA.

The GI jumped on board and although we were rejected initially by insurance the GI did a peer to peer during the appeal and got it approved for 2 years! Woohoo! Hopefully it'll get FDA approval and be out way before that.

So it was a big mess with our specialty pharmacy and I spent a week on the phone between the pharmacy and the patient assistance program for hours each day.

I would initially be told by the pharmacy that the med loading doses would be 40 dollars. Then when they'd dig deeper they'd first have to get clarification on the dose because it was so high then the first time they said without patient assistance the loading doses out of pocket would be close to 100,000.00. After that it would always start with 40 dollar then 68,000.00 dollars. Patient assistance program has a yearly limit of 20,000.00 max so they are still rejecting but finally someone figured it out and our copay was 40 dollars for the loading doses.


The meds came today! It's 3 90 mg/ml shots on day 0, 1 90 mg/ml shot on day 30 then 90 mg/ml shot every 8 weeks.

I'm waiting for a call tomorrow from GI nurse to ensure we have everything right and that it's okay for him to start.

I was so excited that this got approved. C's GI and the nurse were freaking awesome. They really fought for this every step of the way and even said they'd try the compassionate relief route if this failed. We're practically outta meds that treat CD and SpA so I'm really hoping this it.

C will be 20 in less than 2 months. I loathe the day we have to move from his ped GI! I find myself already grieving this.

Anyway, I'll post his Stelara journey here in case anyone else goes this route.

So glad it worked out
I hear ya on crohns /JSpA combo meds

So excited for you!! I hope it's C's miracle drug !!

We are also watching Stelara trials carefully. It was filed for approval 11/15, so should hopefully be approved for Crohn's later this year (for adults of course).

What a battle! So glad you had his GI and nurse fighting for you as well! It certainly doesn't sound like it came easy! :voodoo:

And, great that you were aware of the phase III trials! I'm sure C's GI's respect for your knowledge helped get him into your corner! Since my father's been sick, I've really found that medical staff really do go the extra mile when they see strong family involvement and advocates.

Lots of wishes that this works for C! I really hope this is it for him!

I hope this does the magic your son needs!

Best of luck! Really hope it does work great

Now I absolutely have to shine the light on maya142! She is the one who talked about stelara and the phase III trials.

I swear this disease would seem insurmountable without the support, information, experiences of this forum and especially the Parents section! You all truly rock!

Glad to hear you got the approval! Keep us posted on how he is doing!!!!

Very glad it worked out ! Can't wait to hear you say that C feels GREAT!

I'm so glad you were able to make this happen, and I hope it works really well!

I'm glad he got it.
I will be following this thread with interest.

Yay! Also following as my GIs next choice is Stelara but it isn't approved here so I'm waiting until it is.

So it's been about a week since we took the first loading dose.

3 shots 90 mg each.

He used the synera patches(left them on about 40 mins before shots). He let the shots sit out for about 30 minutes.

The shots could be given top of thighs or tummy. C refuses top of thighs so tummy it has always been. The shots need to be administered 2.5 inches in either side of belly button and not all on one side at the 45° angle.

He came home to do the shots the first time so I could make sure all was done right and you know just watch him because of it being a new med.

All went well. He said on a scale the pain of the stelara shot was nowhere near that of humira and maybe one step above the painless mtx injections.

The med did kind of create that med "lump" at the site but the med dissipated quickly.

He is supposed to be getting blood work (nailing him down to go ughhhhh!) to start sulfasalazine as well for his axial joints. I don't have much hope it'll help but fingers crossed!

I did Stelara for a while and was on 90mg shots. Can't remember the intervals now, but I think it was 8 weeks as well. It did work for me, just now quite enough to get me into remission Hope it works for him!

I found the shots much much much easier than Humira, which was starting to make me pretty anxious when I had to do it weekly. Didn't have any side effects from it either.

Fingers crossed!

Clash! I have missed SO much!

I am so sorry to hear that things haven’t been working out for C, that sucks. :ghug:

But well done to you for getting the preferred drug! Woohoo! I hope it works fabulously well for your lad, bless him. :heart: And good to hear the loading doses went well!

Everything crossed at our end Clash!

Sending support, Clash.

[QUOTE=Clash;943602]Hey guys. I decided to start a new thread since C is starting a new med.

I would initially be told by the pharmacy that the med loading doses would be 40 dollars. Then when they'd dig deeper they'd first have to get clarification on the dose because it was so high then the first time they said without patient assistance the loading doses out of pocket would be close to 100,000.00. After that it would always start with 40 dollar then 68,000.00 dollars. Patient assistance program has a yearly limit of 20,000.00 max so they are still rejecting but finally someone figured it out and our copay was 40 dollars for the loading doses.

The meds came today! It's 3 90 mg/ml shots on day 0, 1 90 mg/ml shot on day 30 then 90 mg/ml shot every 8 weeks.




$100,000 for the loading doses? That is incredible. I am taking Stelara in Canada and each syringe is $5,127CAD. So if your son got 4 syringes for his loading doses it would be close to $25,000 in Canada. I don't understand why it would be so much more in the US??

How did he do on it? I had a bad reaction to the injection with nausea, headache, fatigue that lasted three weeks. for my next one, next week, my doc advised taking Benadryl 50 mg before injecting and then 25mg every 8 hours for two days to hopefully avoid the reaction. In between injections, I'm feeling pretty good.

We still haven't figured out where that dollar amount came from. We're not sure if that is a glitch on the specialty pharmacy side or the payt assist side. Or is the amount was correct. We paid 40 dollars for 4 shots in the end. Payt asst rejected C because the dose was higher than the norm they approve for but it's on appeal.

The first 3 shots on day 0 went well. No side effects to speak of. He did mention fatigue after but he had a really late night the night before so we're not sure if it was that or the Stelara. His next dose is 90 mg shot on day 30 so we hope to see if the fatigue was actually from the shot or just a blip.

Clash,
Fingers crossed for him!!!

So glad insurance issuers got sorted out. Hope Stelara works out for him for a long while!

CrohnsDadNJ said:

So glad insurance issuers got sorted out. Hope Stelara works out for him for a long while!

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Amen

Hope it works great for him.

C just had his reg blood work done. All looked good though it always does when it comes to reg blood work. But, this was also time for an iron panels and his ferritin is looking good so no more iron infusions for now.

He has a follow up with the GI in Nov. At that time he will have done the loading doses and 1 maintenance shot of stelara.

I had the GI nurse note that C has been experience headaches fairly often. He'll be seeing an ENT soon then possibly allergist etc.

Anyway, hope everyone has a great weekend.

How are his joints Clash? Any change since getting off Humira?

Glad the blood work looks good and Ferritin is finally up!! That's promising!

We have heard more than once that Stelara can take 6 months to work, so hang in there.

Glad things are looking good so far.

Maya142, he is still complaining for back stiffness. I can't say that it impedes anything though because he's working and going and doing. We have a rheumatologist appt next Friday so I'm going to push for a MRI.

The rest of his joints seem to be doing fine. He keeps saying he has shin splints but I'm not sure how he know that's what it is. So I'm go8ng to bring that up as well.

Im really hopeful with the blood work. Ferritin has Ben low forever and no amount of iron infusions were helping but something is clicking because his ferritin and other numbers looked really good. And though his HGB has been low normal to right under normal for as long as I can remember it is now over 15 so we're ecstatic about that.

Inflammatory markers have remained the same throughout so no reliable monitoring there. In fact, all his numbers always look good. Only when we run iron panels do we get a glimpse of things awry....but not this time! Yay!

I'll update again after the rheumatologist appt.

I agree that it's a good sign that his iron numbers are good--thanks for the update!

Clash,
We were just discussing IBD and headaches in another group. It seems there is a link between IBD and headaches. There have been several studies showing that people with IBD experience severe headaches 68% more often then the general population.
I will find the articles.

Here is the first one,
https://www.hindawi.com/journals/grp/2016/6474651/

Number two,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4240046/

Just an update:

Maybe 3 weeks ago C had a day of vomiting. He felt nauseated all day and severely fatigued. The fatigue has been continuous since then and the vomiting occurs maybe 1-3 days in 7.

GI requested lab work and stool studies. It had been a calamity getting it done between C and this local hospital.

The Blood work came back all normal. CRP was in the normal range but not as low as it usually is and same for SED.

The FC test was just turned in so no results in that yet.

We are in the midst of changing rheumatologist and C is having a lot of issues with lower back stiffness and pain. He also complains of tingling/ kinda burning says he can't describe it in his calves.

We have a GI appt scheduled in about two weeks.

So not sure what this is maybe he isn't asymptomatic anymore although these symptoms(excluding fatigue) weren't his usual CD symptoms(I know, it can change over time)

He's had his 2nd maintenance dose of stelara last week.

I'll update when I know more.

No advice to give you, just really sorry that you now have this worry and these questions. I'm glad you have a GI apptmt coming up!! At the very least, you'll begin to get some answers then. I am hoping that stelara kicks in soon!! :ghug: :ghug:

Clash said:

Just an update:

Maybe 3 weeks ago C had a day of vomiting. He felt nauseated all day and severely fatigued. The fatigue has been continuous since then and the vomiting occurs maybe 1-3 days in 7.

GI requested lab work and stool studies. It had been a calamity getting it done between C and this local hospital.

The Blood work came back all normal. CRP was in the normal range but not as low as it usually is and same for SED.

The FC test was just turned in so no results in that yet.

We are in the midst of changing rheumatologist and C is having a lot of issues with lower back stiffness and pain. He also complains of tingling/ kinda burning says he can't describe it in his calves.

We have a GI appt scheduled in about two weeks.

So not sure what this is maybe he isn't asymptomatic anymore although these symptoms(excluding fatigue) weren't his usual CD symptoms(I know, it can change over time)

He's had his 2nd maintenance dose of stelara last week.

I'll update when I know more.

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Hoping the best. Sending support and prayers.

Sending hugs! Really glad the GI is seeing him soon.

Clash said:

Just an update:
He also complains of tingling/ kinda burning says he can't describe it in his calves.
.

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Hello, not sure if the 'medications' have a 'possible' side effect of nerve issues, you might want to take a look and see. If yes, this should likely be addressed soon. Nerve damage has a stronger possibility to be stopped if the reason is caught early, left ignored can become permanent and the pain that can potentially happen eventually can be 24/7 and not easily controlled. A neurologist can be helpful in this area.

I am sorry he is suffering in anyway.
Be well, God bless.

Yes, I wonder if it's neuropathy. When I ask if it's tingling he says yes but not really. He said it feels as if he has RLS all day long.. I asked him does it feel as if your legs are "waking up" from going to sleep like numbness and tingling and he says no but he can't explain it either.

We're going to get it checked out. He's on stelara, mtx and folic acid.

Have they checked his B12 level recently Clash? Low B12 can cause nerve issues.

And HGB? When I was anemic, I had RLS... night was the worst but I had it during the day as well. But, not when moving... the sensation was only when I was sitting or lying down.

Second letting gi know sooner rather than later Stelera I think has Cns warnings
Get neuro consult

His B12 was well into the normal range last we checked but probably needs to be done again. His HGB was normal as well. Not even the low normal it used to stay at.

Yes, we're going to mention it to the GI when we go. Unfortunately C says that this has been ongoing but maybe not to the present degree. I asked if it started after stelara but he says no lIngersoll. Still, I worry that the stelara may be playing a role.

But you don't have an appt with gi for two weeks
Since your kiddo doesn't seem like the type to complain
I would try to give the gi the heads up now versus waiting two weeks

A neurologist is the contact point..... (G.I did not address mine took years for primary to refer) now is permanent sever pain 24/7, at times I think it is actually worse then Crohn's with also no current cure.

be diligent, be well, God bless
(but, do not be afraid, it will be OK)

I can let the GI nurse know. I thought about talking to the GP about it when C goes for a flu shot (my lord the nagging that has taken!) but my insurance doesn't require referrals so I could look for a neurologist.

Our Insurance doesn't require referrals either but
If it's neuropathy - a GI can get you into the neurologist faster
Neuro appts for non seizure disorders is a very long wait typically
Many months 3-6
Some have emergency clinics once a month where everyone sits in a room
Until all the patients are seen
We waited over two hours in one of those

But once you have a neuro appts are must faster
Any odd symptoms and ds gets an MRI of the brain and exam

I'm also hoping and decidedly forcefully advocating for an MRI for C at the rheumatologist of his lower back/SI joints. We have e yet to find a rheumatologist that does them at least annually so C has never had an MRI to see what's going on. Always with last two rheumatologist it's been xrays and then a declaration of no damage yet. Well, duh damage/fusion takes time! I'm not taking no for an answer with this new one.

Yeah I'll see if the GI nurse can get us in to see one quicker.

I feel so bad for Clay. He so rarely complains so when he does I have to take it seriously, ya know.

SpA could be causing the tingling too if there is a lot of inflammation. It can sometimes affect the nerves.

I really hope the new rheumatologist will be more proactive! It takes 8-10 years for damage to show up on x-rays, so an MRI is definitely recommended. We do one every year or two to monitor the damage/inflammation.

Hope C feels better soon :ghug:.

I really think it has something to do with his lower back, and he says it's really low low, so maybe SI joints. He also thinks the legs are related to the back but he hasn't said exactly why.

Maya142, I'm going to ask the GI about voltran gel and get the okay so maybe add it to the arsenal when we see the new rheumatologist.

It could be inflammation affecting the nerve - my husband used to have nerve issues when his neck was inflamed.

Honestly, I don't know a whole lot about nerve issues and SpA but I have seen them mentioned on the Spondylitis.org forum.

Low back/butt pain is often SI joint related. Especially given his age, it's likely his SI joints (SpA/AS tends to start there and then move up the spine).

Voltaren gel is a good idea. They even have patches which are less messy (Flector patches). He could also try a TENS unit, my girls say it's sometimes a distraction.

The other thing that might help is steroids until the Stelara kicks in. I know C hates steroids but in SpA they tend to use lower doses (anywhere from 10-20 mg usually), so side effects are not as bad.

Just something to consider...I'm sure he'd have to see a rheumatologist first to get them anyway.

But a PCP should be able to prescribe Voltaren gel while he's waiting. Or his GI.

Clash,
Hope they get this figured out quickly. I am really hoping to hear good things about the stelara as this might be our next step.