Higher dose Entyvio

crohnsinct

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Is anyone here on doses higher than 300mg every 4 weeks? My daughter has been on Entyvio for 11 weeks and she only has a trough level of 11. Her GI said they like to see >20. In order to get that he feels she needs 500 mg every 4 weeks but fears insurance won't approve it. He says there is little written yet to support Entyvio trough levels.

A trough level of 11 is not working for my daughter as she is now on her 4th admit since May 15th and has spent a total of 23 days inpatient.

Just wondering if anyone else has had success getting it approved and if so did the higher dose work for you.
 
Just thought I would update here in case anyone comes across the thread. Our insurance has approved a one time does of 600mg. They said they may approve additional doses subject to additional documentation.

I will keep this thread posted with how she does.
 
Dr. Scherl: This is the first analysis of the ongoing LOVE-CD trial, the first prospective trial showing endoscopic response and remission rates with VDZ in CD. The investigators found that VDZ concentrations were significantly higher in patients with an endoscopic response than in nonresponders.

The investigators found that at week 26, 30% of the patients had endoscopic remission based on the SES-CD. The authors then go back and show that a higher proportion of patients who achieved endoscopic remission at week 26 had a higher VDZ level (20-40 mcg/mL). However, if the VDZ level was less than 20 mcg/mL, they had a very disappointing response, with only 11% achieving remission.

This is an important study because it underscores that if your patient is not responding to VDZ, you should check the therapeutic drug levels of VDZ before switching drug classes. If the patient is on an every-eight-week regimen, and if the levels are less than 20 mcg/mL, you may consider increasing infusions to every four weeks. On the other hand, if they are on every four weeks and their level is less than 20 mcg/mL, then you may consider optimizing the dose to 300 mg every two weeks or 600 mg every four weeks.
 
That is probably more common than you would think. Take a look at it from an insurance perspective. An extra dose of Entyvio is far cheaper than a hospital stay that might lead to surgery.
 
You would think right? But actually a 300mg dose of Entyvio infused at the hospital is $30k. Double the dose would be close to double that. So our doc asked around and apparently no one has ever had success at getting that dose approved. Plus, if it works, she will likely need that dose for a while. She was just patient for 33 days and the charge for that wasn't bad comparatively speaking. But I think insurance looked at it rationally and said while the one week stay and surgery are probably cheaper in the long run, it just wasn't moral to make a 19 year old get a colectomy to save a little money. So we are hoping it works and hoping they continue to approve the higher dose. Soon she will be back at college and can do home infusions which are a lot less expensive. Also, as she heals it is likely she won't metabolize the drug so quickly as less will be passed in her stool and maybe we could go back down but honestly she has always needed the upper level of every drug she is on. Darned high metabolism;)
 
Association of trough vedolizumab levels with clinical, biological and endoscopic outcomes during maintenance therapy in inflammatory bowel disease

  1. Nikolas Plevris1,
  2. Philip W Jenkinson1,
  3. Cher S Chuah1,
  4. Mathew Lyons1,
  5. Lynne M Merchant1,
  6. Rebecca J Pattenden2,
  7. Ian D Arnott1,
  8. Gareth R Jones1,
  9. Charlie W Lees1
Author affiliations

Abstract

Objective To establish the relationship between trough vedolizumab levels and outcomes during maintenance therapy.
Design Cross-sectional service evaluation was performed on patients with inflammatory bowel disease (IBD) receiving maintenance vedolizumab therapy (minimum of 12 weeks following induction). Prior to infusion, data on clinical activity (Harvey-Bradshaw Index or partial Mayo score), trough C-reactive protein (CRP)/vedolizumab levels and faecal calprotectin were collected. Endoscopic data (±8 weeks from vedolizumab level testing) were obtained by review of medical records. Vedolizumab levels were processed using the Immundiagnostik monitor ELISA.
Setting The Edinburgh IBD Unit, Western General Hospital (tertiary IBD referral centre).
Patients Seventy-three patients (30 ulcerative colitis and 43 Crohn’s disease) were identified who fulfilled inclusion criteria and had vedolizumab levels matched with clinical activity scores, CRP and faecal calprotectin. Of these, 40 patients also had matched endoscopic data.
Main outcome measures The association of trough vedolizumab levels with clinical remission (Harvey-Bradshaw Index <5 or partial Mayo <2), biologic remission (faecal calprotectin <250 µg/g+CRP <5 mg/L) and endoscopic remission (Mayo score 0/no inflammation and ulceration on colonoscopy).
Results The median trough vedolizumab levels were similar between patients in and not in clinical remission (10.6 vs 9.9 µg/mL, p=0.54); biologic remission (10.6 vs 9.8 µg/mL, p=0.35) and endoscopic remission (8.1 vs 10.2 µg/mL, p=0.21). Quartile analysis revealed no significant increase in the proportion of patients in clinical remission, biologic remission or endoscopic remission with increasing trough vedolizumab levels (p<0.05).
Conclusions In this cohort, trough vedolizumab levels were not associated with clinical, biological or endoscopic outcomes during maintenance therapy.

https://fg.bmj.com/content/early/2019/07/03/flgastro-2019-101197

Well this is a bummer. Small study. Hopefully our insurance company doesn't read it before we request the next double dose of Entyvio.
 
that study seems very flawed. Also I had Entyvio level of 30+ when I was on it. Also I was told that when insurance keeps denying meds you can basically force them to approve by going to the hospital and having a long stay because it will cost more. I remember hearing “hospitals can do anything” although some doctors are not as determined to make you feel better with unapproved fda treatments they would rather say surgery is all that’s left when that’s a total lie. Hope your daughter does well with the 600mg from my experience it will only give you some time before something else is needed.
 
Thanks Kittz128. So did Entyvio not work for you? Even with a level of 30? May I ask where your disease is primarily active?
 
Entyvio worked for me for 2 years but I never knew what my levels were when it was working. My gi doc just put me on 300mg/4week and said good luck. When i had symptoms my new gi got the level and said it was over 30 which is enough to work so we switched to stelara Disease was everywhere I’m told
 
Kittz128,

Yeah. My daughter was put on 300mg q4 from the beginning and no response. As a matter of fact she got worse. We are hoping the bump in dose will get her trough levels up to a therapeutic point and Entyvio will kick in. She had disease in her stomach, TI and entire colon. The colon is the problem child and Entyvio has a better success rate at colonic disease we are told so that is why we went with that over Stelara. Glad to hear Entyvio at least worked for a while for you. Is Stelara working for you now? Had you tried Remicade or Humira before Entyvio?
 
Stelara didn’t work or hasn’t yet lol I’ve been on it for a year. remicade and Humira didn’t work. If you want to try it your daughter should use budesonide for the colon. Also did she try remicade and Humira?
 
We tried budesonide and it didn't work. She was on Remicade for 7 years and she lost response to it...yeah I have read the Remicade thread that Kind is posting on...interesting. My daughter also tried antibiotics. Vancomycin and then triple antibiotics with Doxycycline, metronidazole and amoxicillin. They didn't work.
 
Well which form of budesonide did you try and how long? Also antibiotics are not good. If remicade worked why Entyvio and not Humira cimzia or simponi since they are anti tnfs and she did good on those for a long time
 
She tried Entocort and Uceris. She has tried, rectal foams, enemas and suppositories. The suppositories worked great back in January but recently not so much.

I am really not 100% clear on why not Humira. He said something about switching from one anti tnf to another not being as successful as switching to a drug with a different mechanism.

I am also not clear on why we are discussing surgery so soon and not trying to exhaust more drug options. Although she did get pretty sick and as the surgeon said, you want to use surgery when it is a good treatment option and not a last resort and if we waited too long then surgery wouldn't even be an option.

In my eyes we aren't anywhere near the surgery discussion yet so I am just taking it one step at a time and trying to trust the process. My nephew who had almost the identical disease behavior to my daughter failed Remicade and Humira and ten did great on Entyvio and has been on it for three years now. So here's hoping!
 
How long are you planning on waiting Entyvio out i felt better the next day I got it. I don’t understand why you would do surgery when you are getting better. Who’s idea was that I wouldn’t trust them. Your right you should use all the treatment options especially Humira I mean that’s the best one according to clinical trials it did better than remicade. Also you could add Humira to Entyvio it’s not unheard of. Risk is probably very low.
 
Second humira - Ds was switched from remicade to humira
Worked for over 5 years
But then they switched to Stelara
Said something similar that after 7 years of anti tnf
The body probably wouldn’t respond as well to anti tnf for a while
In Ds case Stelara needed to be higher dose 90mg every 4 weeks to calm his gut
Simponi has better UC results but not as good as humira

@Kittz128
Did they try increasing your Stelara dosing frequency?
 
She is not getting better. She has been on 300 mg Q4 for 12 weeks now and has gone septic. After that admit she was released and then readmitted because her Crohn's was completely out of control. It was rapidly spreading. She has spent a total of 33 days in the hospital over the past month and a half. Her last admit was to improve nutritional status as they felt she was so malnourished that her body was just able to exist and not concentrate on healing. Now with IV steroids/higher dose oral steroids, TPN etc she is finally feeling better. But we really need a maintenance med to kick in as she can't stay on steroids forever.

MLP - interesting about Simponi and the UC results. O has Crohn's but it is VERY UC like. I wonder if the GI would consider that next for her.

There was some talk about combining two biologics as Entyvio is very gut selective so easier to combine with another biologic but for now we are just concentrating on trying to get Entyvio to work.
 
33 days is pretty bad I think. I don’t count days but I think I was inpaitent 2 months in the hospital one stay (kinda why they gave me multiple doses, they said hospitals can do anything just to get me out)
 
the body probably wouldn’t respond as well to anti tnf for a while

Hmmm. Maybe this is it MLP? She was on Remicade for 7 years. Actually now that I think about it, there was some discussion of going back to Remicade/Humira after a long enough break so maybe this was part of his argument to try a different mechanism.

I plan on asking him more about the plan forward at her appointment on Friday.

That article talk about UC which for O would be fine because she has very UC like Crohn's. Do you know if GI's are using Simponi for Crohn's?Is insurance approving it?

Kittz128 - IDK how long the GI is planning to give Entyvio. It has been 12 weeks but she wasn't at an optimized dose. So I know we have this dose approved but IDK if she doesn't respond to this dose if he will consider it a fail or try for another 12 weeks at the higher dose. Or add something or just try a different drug.

I forgot to mention that she was also on Tacrolimus and that also did not hold her disease. Even on 40mg of steroids she still ended up in the hospital. She is just now at a point where she is only going 5 times a day but bleeding every one of those times.
 
Regarding simponi I can almost guarantee insurance will approve it given that crohns and uc patients have been using the same drugs for decades. No surprise Tacrolimus didn’t work. It’s practically useless for ibd in my opinion. Steroids don’t work on 1/3 of patients so not surprised with that either and 40mg is not a high dose. Try 80mg for 2 weeks if you want see what happens then taper 5 mg a day to 40.
 
Just my opinion and experience I’ve used it. I think when you truly have severe crohns no simple drug would induce remission. That said it’s probably worked for people but probably not for very long. I think anyone with severe ibd will need a biologic to actually get remission I mean even steroids don’t work on a lot of people because it’s so severe you need a strong drug like a biologic. Just my thoughts
 
My daughter started Tacrolimus at the same time she started Entyvio and it still did nothing. There was a parent on here who had a daughter with U.C. (or at least that was the dx) and she did very well on Tacro. Also, our GI seemed very surprised that it didn't work for my daughter as did the admitting GI's . Hmm. Guess it is like everything else with this dumb disease...individual!
 
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