Next Step for Little Farm Girl

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😢 Grace reacted to Remicade again.
They gave her a bunch of steroids, Benadryl and such.
Tried again and same symptoms came back.
The Rheumatologist told us he'd pull it next time it happened but we'll
get the new game plan tomorrow.
She only got a quarter of her Remicade,
So hopefully the change will come quick.😩

Any ideas, suggestions, bets, wagers, guesses and or fortune telling to know what happens next?
 
Last edited:
Ahhhh, I see you are playing our favorite game Outguess The GI!

Which disease is worse right now? Her JSPA or her IBD? I think that might have a lot to do with which drug they choose next.
 
So since she burnt through
Humira and remicade
But is under the age of 12
Odds are Simponi (does better woth jia )
Vs cimiza (does better with ibd )

Entivyio is out -it only treats ibd
Stelara is only approved for adults
But they will sometimes use in kids OVER 12
Per dermo /rheumo /GI
There is a big difference on what they are willing to try when kids are 12 yet

Cimiza is in trials at cchmc for GI
Not sure Simponi is in any trials

Wait forgot Stelara is approved for psoriatic arthritis in adolescence
Only issue is that dose is way too low
Crohns dose for Stelara is much higher
Even then Ds needed every 4 weeks at 90 mg

So long short

No good options
Simponi works faster (3-5 months )
Stelara is not great at JSpA in my opinion
Takes high doses and about 8 months or more

Good luck
But prepare for long Steriods
 
Simponi is an option. Cimzia is an option. In terms of trials, actually Cimzia did better in trials than Simponi. This was specifically for polyarticular JIA.

Cincinnati Children's definitely has a Cimzia trial, a Xeljanz trial and probably others.

But I think Simponi and Cimzia have been out long enough that they've been used for JIA a lot. One of them is even approved in the EU for poly JIA - Simponi I think.

They may also mention Acemtra and Orencia. Orencia targets T cells or something like that and Actemra is an IL-6 inhibitor. Neither work for Crohn's.

For Simponi vs. Cimzia, M has been on both. M says she liked Simponi better. She did better on it for both her gut and her joints. But she needed a high dose of it - double the IBD dose (which is double the arthritis dose). So basically 4x the actual dose for AS.

Cimzia works for her gut but not her joints at all.

Simponi also has an IV version available, but it's not approved for kids. Trials may be starting for JIA though. It's called Simponi Aria. Infusions are short, every 8 weeks.

We only did the Simponi shots. They were painless, even with the pen. Both my girls did their own shots.
Cimzia - it is very thick so the shot takes a long time. It doesn't burn like Humira but it does sting and hurts when injected.

Simponi is every 4 weeks, though we were on it every 2. Cimzia is either every 2 or every 4 weeks.

Stelara is another option, but if she has SI joint involvement (back pain/butt pain) then an anti-TNF is better. Stelara failed for AS, so it shouldn't be used if she has spinal involvement.

I'm sorry she has to switch...:(
 
So sorry, Farmwife. Hope the new game plan is a good one that works well for Grace.
 
Heard from the nurse.
Her doc says no new med for 3 to 4 weeks. 😫
I know this is a normal wait but worried about a flare up.
Grace is to go and get GI check up to make sure her crohns is indeed in remission.
We have to go next week to see the rheumatologist and talk in person about her next meds.
 
Yikes!!! We have NEVER done that. I know Remicade stays in her system for a while, but it sounds like she didn't much Remicade at all!

I know you were on infusions every 2 weeks though, so I suppose she does still have a good amount of Remicade in her.

But yes, I would worry about a flare. My girls have switched biologics many times - including M from 20 mg/kg of Remicade every 4 weeks to Simponi - and have never had to wait in between biologics.
 
I've heard of it twice on the jia group I'm apart of.
One child ended up on prednisone for a bridge therapy and the other ended up in the hospital.😩Hopefully this won't happen to Grace.
 
Yikes

Ds took humira on a Monday and had Stelara infusion on Wednesday I think
No wait
Granted humira wasn’t doing anything st that point

We did have to wait though in the same drug class
So when he reacted to remicade
We had to wait 6 weeks to start humira
And of course he then flared while waiting for humira to build up


Btw also flared when switch to Stelara without the wait so ..,.
Not sure you can avoid even with steroids on board at low level
 
Tomorrow is the big day.
We go down to talk about her next options.
It sounds like her docs are open to all of them.

My question or thought process is,

If we went with a drug that treated just her jia, could mtx be enough to keep her Crohn's at bay?

Her jia had always been more aggressive.
 
We tried it, except with Imuran (M cannot tolerate MTX). M went on Cosentyx which can treat AS. Unfortunately, not only does it not treat IBD, it can make IBD flare :ybatty:.

Her IBD had been stable for quite a while. Her AS was a disaster. So we tried it. Within 4 months, Fecal Calprotectin went up. We added Entocort which she stayed on for a year. Then being on steroids for so long caused complications. Then tried a second biologic - Entyvio, then Cimzia.

On Cimzia, she is improving and actually had a pretty good scope today, in terms of IBD!!

She is now on 2 biologics. She is her GI's first patient on 2 biologics.
 
Wanted to add - for poly JIA, Orencia and Actemra are options. Like you know, they don't work for IBD.

But for enthesitis related JIA/juvenile spondyloarthritis, there isn't much evidence that they work at all. Especially if the child has a lot of enthesitis or SI joint/spine involvement.

I have heard some kids JSpA/ERA who have done well on Actemra. But of course, it is trial and error.

You do still have two options that work for both IBD and JIA/JSpA - Simponi and Cimzia. Those would be the simpler options.
 
I can say for ds
Stelara is helping his JSpA and IBD
It just took forever
At one point we had to pull humira and were just on mtx
Definitely was not enough for his mild Ibd

Per Ds rheumo and GI
Once you get past Remicade and humira
It is purely trial and error
What works for one may not work for another
Since success rate numbers at that point are so very very low

Good luck
 
Forgot Stelara!! That's another good option for JSpA and IBD.

However, if the spine is involved (or SI joints), it did fail in AS, so that's something to think about. Since both my girls have spinal involvement and SI joint fusion (partial) every single rheumatologist we asked (and we asked at least 5-6) said no to it.

But if there is no spinal involvement, it works well for joints and enthesitis.
 
There's no evidence of erosion in the SI joints...... Yet.
But her rheumatologist is treated her as if it's a possibility because of the pain there.
But no dx at this time, thank God!
This is why we treat aggressively!
 
Did she have inflammation in her SI joints? Bone marrow edema? Because that is a pre-cursor to erosions and would also qualify as having SI joint involvement. Sacroiliitis just means inflammation of the joint, not damage.
 
Our rheumo
Had a different opinion on Stelara and the spine
What he has seen
It does work ....
Was it the level of inflammation
Was it truly AS ...
No idea
Moderate to Severe definitely failed though

That said Lp had an mri and no erosions on his spine so...
 
In psoriatic arthritis, Stelara does work in the spine, though the dose is very low - much too low according to our rheumatologists. But spinal disease is milder in psoriatic arthritis- less fusion etc. and trials show it does work.

In AS, trials were discontinued because it failed. Ankylosing Spondylitis is a whole different beast, I think. You have to have a certain amount of damage just to be diagnosed with it.
 
I will say Ds is on the max Crohns dose
90 mg every 4 weeks
psA is 45 mg every 12 weeks I believe
Big difference;)
 
Yes, if you do try Stelara, insist on the Crohn's dose. Normally 90 mg every 8 weeks vs. 45 mg every 12 for PsA.

Every single rheumatologist has mentioned the dose and how it is just far too low.

Expect a battle with insurance for most of these meds...Cimzia, Simponi, Simponi Aria and Stelara are not approved for kids.

Actemra and Orencia are.
 
Trip canceled. She caught the summertime cold virus.

As to the SI joint, mri showed nothing but upon physical
Exam she had tenderness in that area. Still does if not worse now. No other testing has been suggested.
 
Mri would show inflammation
If it was clean your good
Tenderness could be muscular or or ...
Ds has a clean mri but so pain
 
Tenderness is not enough to diagnose spinal/SI joint disease. If the MRI was clean, you're good.
 
Yes, if you do try Stelara, insist on the Crohn's dose. Normally 90 mg every 8 weeks vs. 45 mg every 12 for PsA.

Every single rheumatologist has mentioned the dose and how it is just far too low.

Expect a battle with insurance for most of these meds...Cimzia, Simponi, Simponi Aria and Stelara are not approved for kids.

Actemra and Orencia are.

Stellar it is! Insurance battle it will be. :lol:
He wants her on a low dose.
Upping mtx until she starts new drug.
 
:yfaint:ustekinumab45 MG/0.5ML Soln

Commonly known as:STELARA

Just read her portal and this is the dose he's asking for.
I'll contact him and ask to clarify why not the 90.
 
How much does she weigh? It could be based on weight.

But the adult Crohn's dose is 90 mg every 8 weeks.
The adult psoriatic arthritis is 45 mg every 12 weeks.

That is a BIG difference. Most rheumatologists have told us that the 45 mg dose is useless in adults. Stelara was an absolute NO for my girls who have severe arthritis and spinal involvement. All the rheumatologists we talked to (which was 5 or 6, both adult and pediatric) said they had tried the 45 mg dose and failed.

But they had tried that dose on adults and teens who probably weigh much more than Grace.

Stelara also does take 6 months to work, so be prepared for steroids.

And you'll probably have a battle with insurance :( since it's not approved for kids.
 
She's 74 lbs.
I'm wondering if it's easy to get insurance approval at a lower dose.
Don't have a clue.
Any studies I can link in my email to him?
 
https://journals.lww.com/jpgn/Fullt...for_Resistant_Pediatric_Crohn_Disease.28.aspx

Dosing in 7
Year old

https://clinicaltrials.gov/ct2/show/NCT02968108

Clinical trial



In patients with CD, an initial IV induction dose based on body weight (6 mg/kg ustekinumab) is recommended, followed by SC ustekinumab administration. The first SC dose of 90 mg should take place at week 8 after the IV dose. Afterward, dosing every 12 weeks is recommended. Patients who do not show adequate response at week 8 (after the first SC dose) may receive a second SC dose at this time. Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks. Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment. No pharmacokinetic data are available either in elderly or pediatric patients with impaired renal or hepatic function.


From

https://www.dovepress.com/next-gene...ease-an-ev-peer-reviewed-fulltext-article-CEG


Ustekinumab in CD

The Phase IIb CERTIFI trial evaluated the efficacy of ustekinumab in adults with moderate-to-severe active CD who had previously failed to respond to anti-TNF agents.24 The primary endpoint was clinical response (≥100 points reduction from baseline CD Activity Index [CDAI] score). At induction, 526 patients received a single IV ustekinumab infusion at doses of 1, 3, or 6 mg/kg versus placebo. The primary endpoint was reached in 36.6%, 34.1%, and 39.7% of cases receiving ustekinumab (for 1, 3, and 6 mg/kg ustekinumab, respectively), as compared with 23.5% for placebo (p=0.005 for the comparison with the 6 mg/kg group). There were no statistically significant differences in the rates of clinical remission (CDAI <150). During the maintenance phase, 145 patients with clinical response were re-randomized at week 8 to receive SC injections of ustekinumab 90 mg or placebo at weeks 8 and 16. Rates of clinical response and clinical remission were significantly increased with ustekinumab as compared with placebo (69.4% versus 42.5%, p<0.001 and 41.7% versus 27.4%, p=0.03, respectively) at week 22.

The approval of ustekinumab for the treatment of moderate-to-severe CD was based on data from three pivotal Phase III trials which showed that treatment with ustekinumab induced clinical response and maintained clinical remission in a significantly greater proportion of patients with moderate-to-severe active CD after 1-year therapy compared to placebo: two induction trials (UNITI-1 and -2) and a maintenance trial (IM-UNITI trial).25

The UNITI-1 trial included patients with CD who were refractory or intolerant to anti-TNF (n=741), and the UNITI-2 trial included patients with CD refractory or intolerant to conventional therapy, glucocorticoids, or immunomodulators (n=628). Patients were randomly assigned to receive a single IV dose of ustekinumab (130 mg), a weight-range-based dose of ustekinumab (6 mg/kg), or placebo. Clinical response at week 6 (decrease from baseline in CDAI score of ≥100 points or a CDAI score <150) was assessed. In both trials, those patients receiving ustekinumab had a significantly higher rate of response after 6 weeks than placebo: 34.3%, 33.7%, and 21.5%, respectively (p≤0.003) in UNITI-1 and 51.7%, 55.5%, and 28.7% respectively (p<0.001) in UNITI-2.

Patients who completed the induction phase and had a clinical response to ustekinumab (n=397) were included in the IM-UNITI trial. They were randomly assigned to receive SC maintenance injections of ustekinumab (90 mg either every 8 weeks or every 12 weeks) or placebo. After 44 weeks, more patients receiving ustekinumab were in remission (CDAI score <150) than those receiving placebo: 53.1% and 48.8% of patients receiving ustekinumab every 8 weeks or every 12 weeks, as compared with 35.9% of those receiving placebo (p=0.005 and p=0.04, respectively). The main results of this trial are summarized in Table 1.


Table 1 Phase III randomized controlled trial with ustekinumab in patients with moderate-to-severe Crohn’s disease

Notes: Data from Feagan et al.25 UNITI-1 and -2, two induction trials; IM-UNITI, maintenance trial.

Abbreviations: CDAI, Crohn’s Disease Activity Index; IV, intravenous; SC, subcutaneous; TNF, tumor necrosis factor.

A recent Cochrane review concluded that high-quality evidence suggests that ustekinumab, at an optimal dose of 6 mg/kg, is effective for induction of clinical remission and clinical improvement in patients with moderate-to-severe CD.26

Apart from randomized clinical trials, retrospective studies have shown the clinical efficacy of ustekinumab in around two-thirds of patients of real-life cohorts consisting of patients who had failed to respond to anti-TNF agents.27,28 Data on reduction of C-reactive protein or improvement of endoscopic lesions have also been obtained.29,30 Endoscopic (mucosal healing) or radiographic response was observed in >50% of patients with refractory CD in a retrospective study.31

Moreover, ustekinumab appears to be highly effective in the treatment of the paradoxical psoriasis-like lesions induced by the use of anti-TNF agents in patients with CD.32–35 These are the most frequent dermatologic adverse effects in CD patients receiving anti-TNF agents.

Papers on pediatric use


Bishop C, Simon H, Suskind D, Lee D, Wahbeh G. Ustekinumab in pediatric Crohn disease patients. J Pediatr Gastroenterol Nutr. 2016;63(3):348–351.

68.

Rinawi F, Rosenbach Y, Assa A, Shamir R. Ustekinumab for resistant pediatric Crohn’s disease. J Pediatr Gastroenterol Nutr. 2016;62(4): e34–e35.

69.

Cameron FL, Garrick V, Russell RK. Ustekinumab in treatment of refractory paediatric Crohn disease. J Pediatr Gastroenterol Nutr. 2016; 62(3):e30
 
Ustekinumab in Pediatric Crohn Disease Patients.
Bishop C, et al. J Pediatr Gastroenterol Nutr. 2016.
Show full citation
Abstract
OBJECTIVES: We describe the use of ustekinumab for 4 patients with pediatric Crohn disease treated at the Seattle Children's Hospital Inflammatory Bowel Disease Center.

METHODS: A retrospective chart review was done to identify patients' clinical data, disease phenotype, treatment history, and laboratory and growth parameters before treatment with ustekinumab and at last follow-up. Adverse events while on ustekinumab were also recorded.

RESULTS: Four adolescent patients with Crohn disease at our center received ustekinumab. All had previously received corticosteroids, methotrexate, azathioprine/6-mercaptopurine, and both infliximab and adalimumab. Patients had varying disease phenotypes. Ages at ustekinumab initiation were 12, 13, 16, and 17 years. Weight ranged from 40.5 to 57.8 kg, mean 49.5 kg. Two patients showed clinical response and remain on ustekinumab. Two patients discontinued therapy because of continued symptoms and disease complications and required multiple hospitalizations.

CONCLUSIONS: Ustekinumab was used in 4 children with pediatric Crohn disease with 2 of 4 patients showing clinical response (1 with persistently elevated C-reactive protein). A prospective study is needed to define its efficacy, safety, and placement in managing pediatric Crohn disease in the future.

PMID 26854655 [Indexed for MEDLINE]


From

https://www.ncbi.nlm.nih.gov/m/pubmed/26854655/
 
Yeah that^ and at DDW they were saying higher dose and more frequent induction schedule is best for everyone.
 
P625 Ustekinumab use in Crohn's disease: effectiveness of dose escalation
Greenup A., Rosenfeld G., Bressler B.

University of British Columbia, Gastroenterology, Vancouver, Canada
Background
Efficacy of ustekinumab (UST) in Crohn's disease (CD) has been demonstrated in clinical trials. In the absence of therapeutic drug monitoring, empirical dose escalation has been considered as a strategy to optimize response in patients with either primary or secondary non-response. Efficacy and safety of UST 90mg subcutaneous (SC) every 4 weeks is not known.
Methods
A retrospective, observational study of compassionate use of UST in CD was conducted at a Canadian tertiary centre. A subset of patients in whom dose escalation (90mg SC every 4 weeks) had occurred was identified. Symptomatic response, defined as physician documentation of improvement of CD-associated symptoms and continuation of therapy, following dose escalation was assessed, as was biochemical or endoscopic response if available.
Results
Ustekinumab was dose escalated in 16 patients (9 males) of median age 47 (IQR 34–54); disease duration of 12.5 years (IQR 8–18) and location of ileal (4); colonic (4) and ileocolonic (8), with accompanying perianal involvement in 8 patients. All patients were anti-TNF experienced. Fourteen patients had been induced with standard SC dosing (90mg Weeks 0, 1, 2) and 4 with higher SC dosing (270mg Week 0; 180mg Weeks 1 and 2). Dose escalation occurred for primary and secondary nonresponse to UST in 7 and 9 patients respectively. Nineteen percent (3/16) of patients had a response to dose escalation, while 10 patients have ceased therapy. A myopathy developed in one patient and was considered possibly related to UST; dose has been subsequently de-escalated. No additional significant adverse events were reported in the remaining patients who received dose escalated UST.
Conclusion
In this subset of real-life experience of UST use in patients with CD, maintenance dose escalation to 90mg every 4 weeks had a modest benefit in achieving a clinical response. This may be suggestive of the mechanism of loss of response to UST being driven by factors other than low bioavailability due to processes such as rapid clearance. Further assessment in larger cohorts as well as the use of therapeutic drug monitoring will be important to evaluate the usefulness of dose escalation for patients on UST.


From

https://www.ecco-ibd.eu/publication...sease-effectiveness-of-dose-escalation-2.html
 

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