Biologics treatment for Ulcerative Colitis

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RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/4/2017 11:35 AM (GMT -6)   
Hello all,

I was diagnosed with ulcerative colitis throughout the entire colon (“Pancolitis”) (mild / moderately severe colitis) a couple of years ago. Since my diagnosis, I have been on Budesonide, Lialda enema, Lialda tablets, Imuran (Azathioprine) tablets, etc.

Currently, I am on Prednisone (10 mgs a day), Lialda (2 tablets daily, 1.2 gms each tablet), Imuran (Azothioprine, 2 tablets, 50 mgs each). I started flaring some months ago and took Prednisone (40 mgs) and now I am tapering it down (at 10 mg now) and under the advice of the doctor, I am thinking of taking the next step towards Biologics treatment (Humira, Remicade, Entyvio). Since I have not taken any Anti-TNF biologics (Remicade, Humira) before, my insurance will probably approve me for Remicade / Humira before approving me for Entyvio (which I am guessing will be approved only after the Remicade / Humira treatment has failed). I am doing research to find out the following details:

1) What is the remission rate of people who have taken Remicade / Humira / Entyvio? Is there a good website where I can find this information?

The clinical trials had a “Clinical remission” rate of 35% for Remicade (after 54 weeks of treatment) and 17.3% for Humira (After 52 weeks of treatment) (please note sources below). Entyvio clinical trials show that the “clinical remission rate” is around 51% (after 12 months of treatment, I think, but seems quite high compared to Remicade and Humira). All the “clinical remission” rates seem pretty low. For example, only around 17 out of 100 people treated with Humira achieved successful clinical remission, after 52-54 weeks of treatment? Am I interpreting this wrong? Could you please let me know what you all think?

2) How long will I be in continued remission after starting the biologics treatment (either Humira, Remicade, or Entyvio)? Are we talking 2 years or 5 years or 20 years? Is there any percentage data? (meaning, what % of patients who take biologics have stayed on remission for the next 20 years, and what % of patients have not, etc.?)

I sometimes see people in some forums on the Internet, get on biologics, say Remicade for 2 years, then they increase the dosage when current dosage doesn’t work and then move on to Entyvio for a certain dosage and when that dosage doesn’t work, move on to higher dosage and eventually end up in surgery (and get their colon removed). What % of people end up like this?

3) What are the common long-term side effects associated with biologics?

When doing some research on the internet, side effects range from Lymphoma to instances of skin cancer, etc. Some people also suffer from TB and fall prey to other infections, etc. What side effects do you think are common?

Thanks a lot, everybody, and hope you are all in remission or are heading to remission!

God Bless!

Ray

Sources used:

http://www.remicadehcp.com/ulcerative-colitis/clinical-data/clinical-remission

https://www.humirapro.com/gastroenterology/ulcerative-colitis-clinical-data

https://www.takeda.com/newsroom/newsreleases/2017/new-real-world-analyses-support-effectiveness-and-safety-of-entyvio-vedolizumab-for-ulcerative-colitis-and-crohns-disease/


iPoop
Forum Moderator


Date Joined Aug 2012
Total Posts : 10555
   Posted 10/4/2017 2:12 PM (GMT -6)   
1. Generally, 62-65 percent of patients have an initial response to biologics, which means their UC symptoms improve as a result of taking that medication. Generally, 35 percent of patients taking biologics achieve a remission within the study period (most studies are short due to costs). I achieved a remission at a year or a little after thanks to remicade and I might've therefore been excluded from some studies as a remission. I didn't do a medication-to-medication comparison for response because everyone defines Response and Remission differently which makes direct comparisons very difficult if not impossible. There's been no single study that compares them all head-to-head with the same methodology and definitions for saying which is best and by how much. When the studies were done these were considered medications of last resort, so it attracts a certain non-responder-to-everything biased cohort.

2. Let me get out my crystal ball and tea leaves to read your future lol. Just kidding. There's really no data or study on this that I'm aware of. So, the generalization applies to all UC treatments. If the patient is in a deep/quiescent/histological remission than he/she has the best odds of the longest possible, sustained remission. It can be 2, 3, 5, 8, or more years. The bottom line is the prognosis of UC is wildly unpredictable regardless of the treatment given.

The real bugger is if your UC will spread in extent or severity than it is most likely to happen within the first 5 years of diagnosis.

3. If you want to delve deep into the odds of side effects, take a look at this. The Crohn's and Colitis Foundation of America has some good statistics:
Webcast: programs.rmei.com/CCFA139VL/presentation/player.html
Transcript: http://www.ccfa.org/assets/pdfs/risk-and-benefits-transcript.pdf
Moderator Ulcerative Colitis
John
, 39, UC Proctosigmoiditis
Rx: Remicade @5mgs/kg/6wks; daily 75mgs 6MP, 4.8g generic-Lialda, and rowasa

That walk we do, due to post-public-restroom-embarassment, from our awful poop-spolsion in the bowl that flushing alone won't fully hide. Quiet, sly, and as near of a direct-path to the exit as possible...

Connor77
Regular Member


Date Joined Jul 2016
Total Posts : 263
   Posted 10/4/2017 2:47 PM (GMT -6)   
Based on the ACCENT I trial, Remicade has a 26% remission rate at 30 weeks at the highest Dose; for Humira it's 24% at 56 weeks at the highest dose according to the CHARM trial.

There are better options with higher remission rates, but they are not recognized by mainstream doctors right now and difficult to gain access to. So unfortunately biologics are the best thing we have available. Entyvio may have a higher success rate but because it's a newer drug the data is lacking.

The remission rate of biologics increases if you are taking other immunosupressive therapy, like 6MP, azathioprine, 5-ASAs, etc. However they also increase the risk of complications and side effects. Note that the studies above looked at the biologics as stand-alone treatments, not in combination therapies.

It is said that you can also increase the success rate of biologics by finely tweaking your diet and lifestyle. The trials mentioned above did not take these factors into account. They just gave random people the drugs and recorded the results.

RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/4/2017 3:08 PM (GMT -6)   
1. Thank you, John, for your quick and detailed response!! It is interesting to note that the treatment effects have to be thought of in terms of "response" rates and then later "clinical remission" rates. I should have thought about the fact that some patients might not even respond positively (or respond at all) to the biologics treatment. Hence, your emphasis on the difference between response and remission rates is much appreciated. That is great news to hear that you achieved remission with Remicade in a short period of time! I pray that you stay in remission for a long time!

2. When I did my research on the internet, I noticed that Remicade was approved around 1998 and Humira was approved around 2005-2006 time frame and Entyvio was approved in 2014, I think. I also noticed that all these biologics were approved for Rheumatoid arthrytis (RA) and then later Crohn's Disease (CD). I guess since the auto-immunce disease characteristics are very similar, doctors started using these biologics for Ulcerative Colitis (UC) as well. I thought that there might be tons of data, for example, on Remicade treatment, since 1998 (how fast patients "respond" to remission, how long they stay on remission, on average,etc). Your 62-65% response rate and 35% data points are very helpful for me to understand the efficacy of these biologics. The fact that there is so much UC uncertainty (considering that you said that a patient could be in remission for 2,3,5 or 8 years or more) is a bit unsettling. But, I guess that is the nature of this UC beast. I guess my wishful thinking made me hope for an "average" (on a big data set) continued remission period of 10 to 15 years at least! I, however, realize what you are saying about UC and the effect of biologics on UC.

3. Thank you so much for the link to CCFA. I have read some publications there before. The webcast and the link you provided are really helpful!

God Bless!
Ray

RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/4/2017 3:21 PM (GMT -6)   
Thank you, Connor, for your quick and detailed reply! I did not know that the result of the studies are the results without considering the combined therapies, diet, and lifestyle. That is very helpful to know!

Two quick questions (and the first one might be pretty silly, but I'll ask it just for clarification):

1) As you say, the average remission rate is around 25% (average of 26 and 24). And, John was kind enough to say that "generally" the remission rate would be around 35% with Biologics. Let's say a 30% remission rate. Does this really mean that, on the average, out of 100 patients who take biologics for UC treatment, only 30 achieve clinical remission and that 70 of them do NOT achieve clinical remission (this is the definition of remission rate, is it not?)

2) You had mentioned that there are some options with higher remission rates (than biologics) that are not recognized by doctors. Would you be kind enough to mention them? I am keeping all options on the table and I would like to consider all of them before jumping into the biologics treatment methods. Is it against the policy / rules to mention about these alternative methods in this forum? If it is not, kindly mention them.

God Bless!
Ray

superhenderson13
Regular Member


Date Joined Aug 2017
Total Posts : 52
   Posted 10/4/2017 4:30 PM (GMT -6)   
Ray,

I can try to answer #1 based on my understanding. One of the more experienced members might have better information and I could be 100% wrong.

My understanding is those 70 people you refer to, some might find relief from these medications, but they wont achieve full blown remission. like for me, I was on Prednisone and it relieved all of my symptoms except the bleeding. Based on that, I hadnt achieved remission, but still saw relief. Not sure if that is the case for bios, but that is how I understood their measurement.

I wont worry too much about %'s of remission. like others have said, everyone's case is different including yours. At the end of the day, you arent looking for a treatment with a high remission rate, you're looking for a treatment that gives you remission.
Diagnosed: August 2016
Current Status: Flare since 11/2016
Currently Taking: Entyvio
Past Meds: Lialda, Prednisone, Humira, Azathioprine

RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/4/2017 4:57 PM (GMT -6)   
Thank you, Henderson, for your quick reply and for your clarification!

I think post-1998 (after Remicade got approved), the biologics give UC patients a chance to get back to remission. In that sense, these biologics are good when one compares them to pre-1998 UC patients. You make a good point regarding looking for a treatment that gives one remission!

Since you are on Entyvio now, I can ask you this question. Won't the insurance companies approve Entyvio treatment before taking Humira?

I pray that your flare stops soon and that you are on remission soon!
God Bless!
Ray

superhenderson13
Regular Member


Date Joined Aug 2017
Total Posts : 52
   Posted 10/4/2017 5:05 PM (GMT -6)   
Yes that was my understanding. I failed Humira so the next step was Entyvio. Insurance companies can be so ridiculous. Thankfully I have very good insurance plus I'm under 26 so I have my parents as secondary so I pay nothing, but they can hassle a lot of people unfortunately.

Both Humira and Entyvio have drawbacks and benefits. Humira is nice that they send it to you and you can give yourself the shot versus Entyvio where you have to go to a hospital. Entyvio is nice that its every 8 weeks versus 2 weeks for Humira so you dont have to do it as much.
Diagnosed: August 2016
Current Status: Flare since 11/2016
Currently Taking: Entyvio
Past Meds: Lialda, Prednisone, Humira, Azathioprine

iPoop
Forum Moderator


Date Joined Aug 2012
Total Posts : 10555
   Posted 10/5/2017 3:21 AM (GMT -6)   
No single teatment is a guarantee of a remission with UC. The recommendation is always multiple concurrent treatments taken simultaneously. And if you look at our signatures you will see that to be the case. For example, I take remicade, 6mp, lialda, and rowasa. Getting a response from them all can lead to a remission.
Moderator Ulcerative Colitis
John
, 39, UC Proctosigmoiditis
Rx: Remicade @5mgs/kg/6wks; daily 75mgs 6MP, 4.8g generic-Lialda, and rowasa

That walk we do, due to post-public-restroom-embarassment, from our awful poop-spolsion in the bowl that flushing alone won't fully hide. Quiet, sly, and as near of a direct-path to the exit as possible...

CCinPA
Veteran Member


Date Joined Dec 2014
Total Posts : 928
   Posted 10/5/2017 10:57 AM (GMT -6)   
You are on a maintenance dose of Lialda. Max dosage is 4.8 mg (4 pills/day). Many people stay on the max dosage and others go down to 2.4 mg/day once they have achieved a solid, long lasting remission. It's generally recommended to also be on rectal medications along with oral meds. Since you were flaring I am a little surprised you aren't on higher oral and rectal meds.

Entyvio is the first biologic for me. Insurance usually says you need to fail at either another biologic or an immune suppressor like azathioprine (which my liver didn't like). Since you aren't maintaining remission on aza you might be able to go right to Entyvio. I chose Entyvio because it was developed specifically for IBD and specifically targets just the colon rather than having a systemic effect.

I've been on Entyvio since July 2016, was in remission by October 2016 which was confirmed with a colonoscopy Dec 2016. I've had zero side effects and live a completely normal life other that having to go for an infusion every 8 weeks. Entyvio is just a 30 minute infusion so even that isn't too bad. It takes longer for them to mix it up than it does for the infusion.

My sig still says I am on max dosage of Asacol along with Entyvio, but I am tapering that down to a maintenance dose now. I plan to stay on a low dose because of it's reported benefits in prevention of colon cancer. I am certain that it's the Entyvio that is what is keeping me healthy right now.

I struggled with the idea of going on a biologic for over a year. I had good success with drinking nopal water (water infused with cactus juice) for that year, but when I flared again I made the decision for Entyvio. I don't regret my decision at all.
58 yo female diagnosed w/UC to mid transverse 1/1/13, now UC or Crohn's colitis. Remission since 10/16, confirmed by scope in Dec 16. Current meds: Entyvio 7/22/16, Asacol HD 2 Tabs 3x/day, Capozide 1/day (hypertension). omeprazole. OTC: Loratadine 1/day, multivitamin 1/day.

CCinPA
Veteran Member


Date Joined Dec 2014
Total Posts : 928
   Posted 10/5/2017 11:08 AM (GMT -6)   
P.S. ... you asked about long term side effects. Entyvio has only been on the market for a few years, though it's been in trials for much longer. I haven't heard of any increased problems since it went on the market. All of the side effects were found during the trials and my understanding is that anything that happens to someone when they are in a trial is reported as a possible side effect so some of the things listed may not even be because of the drug itself. The most serious possible side effect for Entvio (PML) has never actually happened with Entyvio. It has occurred in a similar drug so the FDA requires Entyvio has to also carry the warning. I haven't heard of a single case of a patient developing PML during or after treatment of Entyvio.
58 yo female diagnosed w/UC to mid transverse 1/1/13, now UC or Crohn's colitis. Remission since 10/16, confirmed by scope in Dec 16. Current meds: Entyvio 7/22/16, Asacol HD 2 Tabs 3x/day, Capozide 1/day (hypertension). omeprazole. OTC: Loratadine 1/day, multivitamin 1/day.

FlowersGal
Regular Member


Date Joined Feb 2017
Total Posts : 367
   Posted 10/5/2017 2:13 PM (GMT -6)   
Another Entyvio user here. I began my infusions on March 29 and will have my 6th infusion this next Tuesday. I just had a colonoscopy where the visual inspection showed no inflammation. I haven't received the pathology report yet, so whether I'm in clinical remission or complete remission (I might have those terms mixed up or wrong), I am for the most part, free of symptoms. I've been eating pretty much what I want instead of diet modification, although I'm still mostly gluten and dairy free. I have no side effects that I notice. I am extremely tired lately though and I still have some urgency, but those could improve after my next infusion (hoping!). All in all, six month remission of symptoms is pretty darn good, so I'm happy.

I'm not on any immunosuppressants, (I was tested to show that I'm a non-metabolizer of them) but I do take Apriso daily. I didn't have to try/fail any other biologics. I'm on Medicare and it was hassle-free, and with my supplemental, I pay $0, thank goodness, because it is expensive! Entyvio does have a patient-assistance program, should you need it and qualify.
UC pancolitis DX March 2016, Partial Colectomy for diverticulitis Sept 2014
Apriso .375 g x 4/day, Canasa & Uceris foam as needed
Supplements: Zinc, L-glutamine, Probiotics: Reuteri pearls, VSL #3, Folic Acid, CoQ10, turmeric, boswellia, milk thistle, NAC, reservatol, colostrum, glycine
Started Entyvio 3/29/17 (Constant flares since March 2016 only relieved by Prednisone)

RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/5/2017 3:38 PM (GMT -6)   
Thanks Henderson for clarifying that point! I am under the impression that if one fails immunosuppressants (or) if one fails Humira / Remicade, insurance will approve Entyvio.

Thanks iPoop for pointing out the bigger picture! Getting into remission is key, I think. I was trying to find statistics about the percentage of patients who get in remission and the percentage of patients who have stayed in remission for many years. However, I think the bigger picture is that a drug (such as biologics) works well to keep the patient in remission.

Thanks CCinPA for your response! I am glad to see that Entyvio is working for you and that you are in remission. Since Entyvio is gut-specific, it seems to be a much better biologic than Humira / Remica and as you had pointed out, there are very few side effects (even the big ones such as PML). I was on the highest doses of Lialda when I flared. My prednisone was enough to keep me in remission. Hence, the doctor lowered my Lialda considering that I was on a high dose of prednisone. But, it looks like when I am on biologics, I will do a combined therapy, which will include a maintenance dose of Imuran and Lialda (or perhaps a higher dose with the biologics).

Thanks FlowersGal for your response! I am glad to hear that Entyvio is working for you too and that you are in remission. Both of us have pancolitis and your flares were relieved only by Prednisone (before taking biologics). I am in the same boat as you were and I hope these biologics (hopefully, Entyvio) will work to keep me in remission when I completely taper off Prednisone.

God Bless!
Ray

iPoop
Forum Moderator


Date Joined Aug 2012
Total Posts : 10555
   Posted 10/5/2017 5:39 PM (GMT -6)   
As you like statistics so:

Odds of remission and varying degrees of flares

Ulcerative colitis patients in a given year:
  • 48% of people with ulcerative colitis are in remission
  • 30% have mild disease activity
  • 20% have moderate disease activity
  • 1% to 2% have severe disease
70 percent of patients who have active disease in a given year will have another episode of active disease in the following year.

Only 30% of those in remission in a given year will have active disease in the following year. The longer a person with ulcerative colitis remains in remission, the less likely he or she is to experience a flare-up of the disease in the following year."

Source: http://www.ccfa.org/resources/facts-about-inflammatory.html

Odds based on initial disease extent
  • On average, individuals with ulcerative colitis have a 50% chance of having their next flare within 2 years (Rowe).
  • The majority of individuals who advance to more extensive disease will do so within the first 5 years after diagnosis (Rowe).
  • If ulcerative colitis is initially limited to the rectum at the time of diagnosis, fewer than 30% of individuals will go on to develop more extensive disease (Rowe). Approximately 10% of patients presenting with proctitis will develop a pancolitis (Rowe). The disease remains confined to the rectum in approximately 25% of cases (Rowe).
  • If ulcerative colitis involves the rectum and sigmoid colon, there is a 50% chance of more extensive disease progression over 10 years; for these individuals, the rate of complete or partial surgical removal of the colon (colectomy) is 12% over 25 years (Rowe).
  • Pancolitis occurs in 10% of patients (Rowe).
  • Individuals with ulcerative colitis have an increased risk of developing colorectal cancer at a rate of 0.5% to 1% per year (Le); overall, cancer occurs in 3% to 5% of individuals (Khan).
  • Extraintestinal complications occur in approximately 20-25% of patients with IBD (Rowe).
Source: http://www.mdguidelines.com/ulcerative-colitis
Moderator Ulcerative Colitis
John
, 39, UC Proctosigmoiditis
Rx: Remicade @5mgs/kg/6wks; daily 75mgs 6MP, 4.8g generic-Lialda, and rowasa

That walk we do, due to post-public-restroom-embarassment, from our awful poop-spolsion in the bowl that flushing alone won't fully hide. Quiet, sly, and as near of a direct-path to the exit as possible...

RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/6/2017 7:06 PM (GMT -6)   
Thank you so much for compiling those statistics, iPoop! They are very useful! I didn't realize that I am in the 10% of patients who have Pancolitis! Cancer rates are real low, which is good! However, the other statistics all point out that one has to put up a tough struggle against UC (with only 48% people of UC patients being in remission). I guess that biologics mixed with combined therapy, probiotics, etc would help one stay in remission!

God Bless!
Ray

Connor77
Regular Member


Date Joined Jul 2016
Total Posts : 263
   Posted 10/8/2017 10:30 AM (GMT -6)   
Sorry for my delayed reply.

RayB said...
1) As you say, the average remission rate is around 25% (average of 26 and 24). And, John was kind enough to say that "generally" the remission rate would be around 35% with Biologics. Let's say a 30% remission rate. Does this really mean that, on the average, out of 100 patients who take biologics for UC treatment, only 30 achieve clinical remission and that 70 of them do NOT achieve clinical remission (this is the definition of remission rate, is it not?)


Statistically speaking -- yes, that is correct.

RayB said...
2) You had mentioned that there are some options with higher remission rates (than biologics) that are not recognized by doctors. Would you be kind enough to mention them? I am keeping all options on the table and I would like to consider all of them before jumping into the biologics treatment methods. Is it against the policy / rules to mention about these alternative methods in this forum? If it is not, kindly mention them.


No it's not against the rules.

There are two prevailing theories about IBD right now. 1) Auto-immune / immune deficiency 2) Infection or auto-infection (your own gut flora)

I am currently exploring #2. The main suspect for infection is mycobacterium avium paratuberculosis (MAP).

These two websites will explain all:
www.humanpara.org
http://www.crohnsmapvaccine.com/

The doctor (Dr. Borody) who has come up with the antibiotic protocol for MAP infection was also the doctor who invented the protocol for treating stomach ulcers due to h. pylori. H. pylori was considered an alternative fringe theory for stomach ulcers until the researching doctor drank the bacteria, developed ulcers within days, and then successfully treated it with antibiotics that Dr. Borody figured out. The discovering doctor won the Nobel Prize.

Now Borody has moved on to treating people who have IBD with antibiotics. There are a bunch of doctors worldwide who are going this route. Their remission rate is higher than 50% and the clinical studies continue to demonstrate this. Unfortunately these doctors are still a minority. I personally believe that the low success rate of biologics is because we're suppressing the body in the presence of an occult infection. MAP is hard to culture from humans, only two labs in the world can do it at present -- unlike in cattle (where it comes from) where it's extreme easy and they've been doing it for over 100 years. Because standard tests don't find it, the GI community is assuming IBD is always auto-immune.

I recently tested positive for MAP at the Otakaro Lab in New Zealand. They're the most accurate lab in the world right now for MAP testing. If you want to go this route, get tested first. It takes 30 days. I'll be starting the triple protocol shortly.

If you want more studies linking MAP to IBD I can post them here, but I'm going to be starting another thread shortly so I don't have to keep repeating myself.

Coffeemate
Regular Member


Date Joined Mar 2012
Total Posts : 191
   Posted 10/8/2017 8:04 PM (GMT -6)   
As long as you are mentioning alternatives don't forget Low Dose Naltrexone (LDN)

www.healingwell.com/community/default.aspx?f=38&m=3922837

Connor77
Regular Member


Date Joined Jul 2016
Total Posts : 263
   Posted 10/8/2017 9:42 PM (GMT -6)   
I'm on LDN and it works wonderfully smile I'd highly recommend anyone dealing with UC give it a try. It switches the innate immune response from TH2 cells back to TH1 which means less inflammation.

RayB
New Member


Date Joined Oct 2017
Total Posts : 8
   Posted 10/8/2017 10:14 PM (GMT -6)   
Thank you, Connor, for your detailed response that talked about the two prevailing theories of IBD. I did check out Dr. Borody and his triple-antibiotic cure for H Pylori on the Internet. He, along with the other two Nobel prize winners, seem legit. I don't understand why gastroenterologists do not suggest going on the anti-MAP antibiotics in the first place.

I guess two reasons: 1) they don't agree that it is an infection but it is auto-immune (as you had mentioned Connor) and 2) a more cynical reason, the biologics make a lot more money for the pharma companies. In the same way of gathering statistics for biologics treatment on UC, I would like to gather statistics on anti-MAP treatment as well. How many people have been on anti-MAP and have been successfully in remission? What percent of them continue to be in remission? Are there major side effects, etc? I have not yet researched these questions yet but it would be interesting for me to research these topics.

I will continue to research these questions and learn more about anti-MAP. I hope you get back in remission soon, Connor, and that whatever treatment you get is a safe one.

Thanks Connor and Coffeemate for mentioning LDN as a treatment as well. I noticed that some people talked about vivid dreams, etc in other posts but that is only in the beginning of the treatment phase. Perhaps, a low dose will not be harmful and instead, will be helpful for UC (as mentioned by Connor). I will research into this treatment as well.

God Bless!
Ray
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