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Heard from Doc today

Exactly Maya! How do they compare 9.9 to 10.6 and say there was no significant difference. I wouldn't expect there to be. They are practically the same! But 11 (O's level) compared to 20 we are shooting for is significant. FWIW - there are a few studies looking at redo drug levels and they are split on whether a higher level helps and if drug monitoring is beneficial. This is why our GI said that there was little in the way of medical literature to support our request.
 
That article says used faecal calprotectin <250 ug/g and CRP<5 mg/L as evidence of biologic remission and appearance of gut (no inflammation and ulceration) on colonoscopy as evidence of endoscopic remission.

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).
This is Mayo scores for UC; there appear to be two parts, symptoms and endoscopy. https://www.mdcalc.com/mayo-score-disease-activity-index-dai-ulcerative-colitis

This Harvey Bradshaw Index measures symptoms. https://www.igibdscores.it/en/info-hbi.html
 
Yeah. O's Mayo score is a 12. I saw that when I gathered her records to send for a second opinion. Bummer.

Do you agree xmdmom that comparing patients in remission with a trough level of 10.6 and not in remission with a trough level of 9.9 doesn't really tell us much. They are saying that higher trough levels are not associated with any remission. Seems to me you would want to look at a greater difference in trough levels. Like patients with >20 as compared to patients with 10 and then can determine if increased trough levels are relevant. I think the LOVE study I posted earlier in the thread came to the conclusion that higher trough levels do affect remission rates.

Or am I missing something?
 
Exactly Maya! How do they compare 9.9 to 10.6 and say there was no significant difference.
What they're doing is taking a bunch of patients and separating them into groups:

people in clinical remission vs. people not in clinical remission

people in endoscopic remission vs. people not in endoscopic remission

Etc

Then they take the entyvio levels in each group and calculate an average level for each group. If variation in entyvio levels among patients at normal doses really matters for inducing remission, then you would expect the levels of those in remission to be higher.
 
Right Pangolin. But what I am saying is there isn't enough of a difference between the responders trough level (10.6) and the non responders trough level (9.9) to say that trough level doesn't make a difference. They are so close that they are basically the same. So you really can't say that increasing trough wouldn't make difference. They are just basically saying a bunch of people at roughly the same trough all had different responses to therapy. Not saying a lot. Besides it was a very small study.

If you look at the LOVE study their data says that responders had something like >20 trough level and non responders had around a 10 or so...I don't remember the exact numbers and too busy to look them up right now. So in that study, higher trough levels DO lead to improved response.

This just goes to show that you can probably find paper somewhere to prove anything you want. IT also proves our GI's point that there isn't enough consistent data on trough levels for Entyvio for us to petition the insurance company to cover the higher dosing. Thank goodness our GI had such good persuasive skills on his own.
 
We could look at the study to find out the range of levels they had, but there's a good chance some patients had levels closer to 20. In order to make the averages nearly even, any in remission at higher levels were balanced out by those not in remission at higher levels and by those in remission at low levels. So, no apparent effect of varying levels in this study.
 
For some reason, this post didn't post. So this is in response to a question last eve.

They are saying that they didn't find an association between trough levels and remission in their cohort of people with Crohn's and U.C, on maintenance V for between .8 to 2.2 years. Their trough range was 7.9 to 16.1 so none were in the 20s.

They mention that there were some on q 4week schedule but most on q 8 weeks V and the q 4 week schedule group had higher trough V levels and were less likely to be in biologic or clinical remission and possibly had more severe disease. They also did another analysis without these patients and were unable to find an association between trough and remission.

The other study was longitudinal, only had Crohn's patients, and was looking at V levels at <. 5 years.
 
😘 Love having a committee member with access to the complete study details! Thanks xmdmom!

the q 4 week schedule group had higher trough V levels and were less likely to be in biologic or clinical remission and possibly had more severe disease.
Choosing to ignore this part for now! Going to walk my unicorn with my fairy friends now! See y'all in the sandbox!
 
UPDATE

After my last update it appeared that O slid a little. BMs went up to 11 and 12 a day and she started bleeding a lot. However, 3-4 were semi solid so things were still encouraging.

She had her Entyvio infusion yesterday and labs were done.

Shockingly her Hgb (10.8) and Hematocrit (33.6) are improved since discharge. The only thing her GI said would make those false high is if she were dehydrated and considering she is drinking 2 liters of water a day and had a bag of fluids the night prior that is unlikely. He can't explain how it is as high as it is with all the bleeding and how pale she is but we will take it. Honestly she is bleeding at least a teaspoon of blood with every BM and sometimes it is all blood. Toilet paper is sopping with blood.

Her albumin is almost in range at 3.4. This is excellent. He said it was in the dumps at discharge at 2.7. Low albumin is a negative predictor for nutritional status and how you will metabolize the drug. So the improved albumin should help her hold on to more drug.

CRP is up a little bit more at 3.9 or 39 but at least not in the hundreds like before. It was 4.1 at last admit so basically the same.

He ordered a slide review and I will put the results here in case anyone else comes across them.

RBC Morphology: abnormal...makes sense with low HGB and HCT
Polychromasia: level 1+
Toxic Granulation: Present
Dohle Bodies: Present

I looked up these things and some could be from acute blood loss, some intra abdominal abscess, infection (sepsis), and severe inflammation. So as a Crohn's patient probably no surprise there. GI didn't mention them so I assume all is good there.

She has gained a pound from discharge and out of the scary "admit" zone BUT he really wants her at the 15th percentile for BMI so we have work to do there.

Her friend in Texas is moving to Peru for two years and is having going away party this weekend. He o.k.'d her going to Texas until Monday which means holding all feeds (lipids and fluids) for three nights. He said she is being so responsible and working so hard that he will trust her not to drink and to eat CDED and to monitor PICC line status (any fever and direct to ED and admit for 24 hours of IV antibiotics). From there she will fly to Utah and meet the rest of the family where we will spend a week at a softball tournament for T. I will bring her Picc supplies to resume o/n feeds on Monday.

We will do labs in two weeks. If albumin is still good, we will try to decrease the Entyvio down to 500 or 400. He said there is no clinical guidelines for what we are doing. She is the only patient outside of the current clinical trial who is trying this so we are making it up as we go. If Albumin tanks again we will stay at 600. Will have to get insurance approvals.

We are dropping steroids by 10mg starting tomorrow and will wait for the next set of labs to go down more. At that point may go down 5 or 10 more mgs. We need to see if Entyvio is working, she has been on steroids too much the past 2 years and he doesn't want to send her back to school on steroids.

She asked about school in the fall. He slowed her down on that one. No crystal ball. He is 70% confident that she could go but warned her that she is still so fragile and if we push too hard everything can topple down. He said we worked hard to get her where she is and we don't want to risk it. We have a lot of work ahead of us. He would like CRP lower than 1 or 10, no bleeding, near normal labs....She will have to eat A LOT more to show that she can exist without the PICC line (up her BMI) as he does not want to send her back with it if he can avoid it. It is too hard to manage remotely and too high a risk of infection. Plus she is on the swim team and he REALLY wants to get her back in the pool. But if that is the only thing holding her back he will send her with it. So weight check in two weeks with labs and then we may hold nightly feeds for a week and see how she does.

I think this sums it all up.

So he really did know what he was doing all along and we just needed to improve her nutritional status as honestly that is the only change we made. We did put her on IV steroids for a few days and then increased back to 40mg but honestly the steroids were not holding her until we improved her nutritional status. I just wish the inpatient team listened the first time and sent her home with the PICC line as we might have been able to avoid the last admit. Oh well, hindsight is 20/20.

Just holding our breath with the drop in steroids. Hopefully with the improved nutritional status this time it will work! Also hoping the bleeding slows down!
 

Maya142

Moderator
Staff member
It sounds like things are moving in the right direction!! That's wonderful to hear!!

I agree with him - baby steps right now for O. Let's see how she does without lipids overnight. Let's see if the bleeding starts to reduce. We can worry about school once she is a bit more stable.

She is so much like my daughter - she just REALLY hates being out of school. Will do everything she can to avoid missing school.

We have a lot of work ahead of us. He would like CRP lower than 1 or 10, no bleeding, near normal labs....She will have to eat A LOT more to show that she can exist without the PICC line (up her BMI) as he does not want to send her back with it if he can avoid it. It is too hard to manage remotely and too high a risk of infection. Plus she is on the swim team and he REALLY wants to get her back in the pool. But if that is the only thing holding her back he will send her with it. So weight check in two weeks with labs and then we may hold nightly feeds for a week and see how she does.
He's willing to let her go to school with a PICC line?! How will she manage that on her own? Dressing changes, keeping everything sterile - it's not easy. We were trying to figure out how M could do it in college and her GI said she'd really need someone else (aka Mom) who could help her do everything to care for the PICC line and prevent infections. She said an NG tube was MUCH safer.

Very glad to hear she is a bit better! Hope the taper goes well.
 
Maya, not really. He said no picc line was a condition of going back to school but then he saw how sad she got and said well maybe if we have to...if that is the only thing holding you back...maybe we can do it.

Dressing changes are done by visiting nurse or at hospital. She would need to get an extension so she could use two hands because as it is now she absolutely needs another person to do it. Even down In Texas she is going to have to do daily saline flushes and heparin and we practiced how she would coach her friend to help her. Ironically said friend is very skiddish over anything medical so it will be interesting to say the least.
 
I'm so glad things are improving for O!! It sounds like her GI is on the ball and methodically taking her on a healing path one step at a time.
I hope you both have a great (and so well deserved!!!) time with friends and family!!
 

Maya142

Moderator
Staff member
I know that PICC lines can stay in and be used at home and in school. But isn't it much, much safer if she got nutrition via an NG tube? Or shakes that she drinks?
I'm sorry, I'm just shocked that he would even consider a long-term PICC line when she could receive nutrition via an NG tube. I feel like if she is so sick that she requires TPN for nutrition, then she probably shouldn't be in school. Plus, There are so many risks - infections, clots, an embolism...It's scary enough when a parent has to do it, much less a teen! An NG tube is so much safer.
 
I know that PICC lines can stay in and be used at home and in school. But isn't it much, much safer if she got nutrition via an NG tube? Or shakes that she drinks?
I'm sorry, I'm just shocked that he would even consider a long-term PICC line when she could receive nutrition via an NG tube. I feel like if she is so sick that she requires TPN for nutrition, then she probably shouldn't be in school. Plus, There are so many risks - infections, clots, an embolism...It's scary enough when a parent has to do it, much less a teen! An NG tube is so much safer.
Agree with all this. Maybe you could talk to O about how she has a much better chance of going back to school (and making it through the year) if she is using a tube rather than a PICC line, since there's so much less chance of complication. Also, keep telling her about all our kids' stories--about how everyone thinks a tube sounds really hard before trying it, but everyone finds it not-so-bad after the first few days. And I really think it will make her feel so much better physically too.

Good luck with everything this week--hope her trip goes well.
 
Glad to read about the encouraging signs. I wish you both a good trip. Try not to think too much right now - just enjoy your trip. You will have plenty of time to worry about it all after your trip.
 
I think the issue is more that he really doesn't want to send her back to school needing supplemental nutrition period. Since nutritional status seems to be so important to her either succeeding or not I really think he wants to know that she can do it before she leaves.
I honestly think he entertained the idea of the PICC line staying in just to appease her in the moment but also as a stop gap just for the first couple of weeks "just in case" she slides at which point she would be brought home and medically withdrawn from the semester. It isn't really a long tern solution to be used at school. Sorry I didn't explain that fully.
 
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Oh man O really is an amazing young woman. It is amazing how can she can hold up so well emotionally, plan travel and be so determined to go back to school. I forgot where but I think she goes to school in my region. If she does (so hopeful) you know I will gladly go put eyeballs on her for you. We can create a reason for a crazy random internet woman showing up.

I hope this weekend you can take a break and focus on the rest of your life. It sounds like she is prepared to handle the line, is learning about importance of reporting issues, and needs some fun. Hoping for more improvement in Utah!
 
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The thought of her travelling plus dropping steroid levels sounds very risky. She is in a very fragile state.
Praying that being with friends gives a psychological boost to counteract the physical stressors.
 
She reports that she feels FABULOUS! This is wAy better than her usual "fine".

Her and her friend handled picc line heparin flushes like experts. She is ready to fire me as her nurse.

She stayed on cded the whole weekend with the exception of one chicken taco that she ordered "trashy". Which means they put queso on it. In addition to being dairy pretty sure said quest is processed but she got the GI's approval for a 10% cheat so she is quite pleased with life right now.

She flies to Utah tonight, we pick her up at midnight and start her o/n lipids and fluids again. Even though she swears she probably gained all the weight her GI wants her to gain over the last two days. 😂
 

Tesscorm

Moderator
Staff member
O is the ultimate 'where there's a will, there's way'!! Even with all the extra coordination and organizing that is currently part of her life, I hope it's smooth sailing until she is truly in a stable place!! The two of you truly are real troopers!! :D
 
OMG. I'm so glad she was able to enjoy time with friends (and even a taco!!). She deserves so much credit for handling the medical/dietary end, which we all know is no easy task, especially in social situations, and for never losing sight of the joy!! I know you must have been worried and look forward to seeing her tonight. Kudos to you both!!
 
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