Biologics treatment for Ulcerative Colitis

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/

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

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.

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.

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.

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.

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

As long as you are mentioning alternatives don't forget Low Dose Naltrexone (LDN)

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