Crohn's Disease Forum » General IBD Discussion » Correspondance with CC UK r.e use of biologics - thoughts?

09-28-2017, 06:13 AM   #1
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Correspondance with CC UK r.e use of biologics - thoughts?

Hi all, the following conversation was exchanged with Crohns Colitis UK and I am wondering people's thoughts:

Hi I am messaging you about NICE guidelines for biological treatments for Crohnís. NICE states:

"Infliximab or adalimumab should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter. People should then have their disease reassessed to determine whether ongoing treatment is still clinically appropriate.

Treatment with infliximab or adalimumab should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. Specialists should discuss the risks and benefits of continued treatment with patients and consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People who continue treatment with infliximab or adalimumab should have their disease reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. People whose disease relapses after treatment is stopped should have the option to start treatment again."

I find this concerning. If the treatment puts you into remission this is excellent - why would you then stop the treatment and therefore enter a flare? By nature of the disease if you are severe enough to get biological treatments on the NHS then after stopping them after 12 months you WILL flare again. Itís the treatment keeping you in remission! Furthermore, I am sure you are well aware of the body of evidence showing stopping and starting this treatment significantly increases the risk of building antibodies therefore rendering a previously effective therapy useless.
Itís so hard to find a therapy from the limited ones available that works and gives us back our quality of life. What can we do to change these guidelines that seem to be driven by anything by scientific evidence and are purely cost motivated with no regard for the patient?
The NICE guidelines are in place to ensure that treatment is reviewed and discussions are made between the patient and the consultant. As every patient is different in how they respond to treatment having a 12 month review gives the opportunity to discontinue therapy if it is not right for that person, but this does not necessarily result in treatment being stopped for everybody. The decision to continue to fund treatment (or to stop) will be made at the local level and will involve discussions between the personís consultant and the local commissioners who pay for treatment. If a person is concerned about the discontinuation of their treatment they will need to discuss this with their consultant.

It is also important to point out that NICE may review these guidelines in the future; more information on how guidelines are developed can be found here:
Hi there, thanks for your reply. Sorry if my message wasn't clear - I absolutely think all patients should be reviewed every 12 months - if not more frequently, whether they are on biologics, immune-modulators or even no treatment at all. Absolutely patients should be given the option to discontinue a treatment that may not be right for them - be it not helping their IBD, side-effects or any other reason causing an intolerance.

My concern is specifically surrounding patients who are prescribed biological therapy, find it helps them, puts them in remission and then they are told their therapy needs to be discontinued because NICE states: "it should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary".
However, no active disease means the therapy is doing it's job. As stated, stopping and starting therapy like this could lead to building antibodies, but it could also lead to the development of scar tissue due to the cycle of inflammation and healing process.

I wonder if you have any thoughts on this? I appreciate in your above post you address the need for yearly reviews to enable patients who are intolerant to their treatment to then discontinue it so that they can find a treatment that works. But I am wondering about your thoughts on the patients that find success with a biological treatment, and with that success, find they are no longer eligible to continue it. What can be done about this?
Biologic treatment for Inflammatory Bowel Disease (IBD) does affect people very differently. We have heard from people that have been put on biologic treatment and completed a year of treatment. These results have varied from those who remained well and in remission, through to those whose symptoms came back. Those that have remained well after their treatment has been stopped, have said why would they risk continuing a treatment which has many risks to them. For most patients who contact us, some have been concerned about the long term use of such medication, which studies have indicated the issues from being on such medication for a long period of time.
Another of the biggest concerns is the risk factors from starting and remaining on such a powerful drug, which is very different to medication like steroids (and antibodies that you have mentioned). .

We also have been contacted by patients whose symptoms have returned and are concerned about getting the same medication or if the medication would have the same effect as before. Then there are the issues you have raised with regard to scar treatment.

One clear understanding we have from people with IBD, is that they want to live a life free of medication (of any kind) which unfortunately may not be the case for patients

There are studies currently being undertaken on the stopping and starting of biologic treatment. Decisions about starting and stopping biologic treatment will be made by a multidisciplinary team with the views of the patient included, with a monitoring plan in place if they have stopped treatment.

Therefore unfortunately it is a complicated argument on the process and evidence, against unknown factors for those patients with IBD. We hope that the studies currently being undertaken can shed further light on improving the way forward for patients.

2nd Generation affected

Symptoms since 08/2006 (age 17)

Emergency open bowel resection after perforation in 12/2011 (age 22) (wrongly diagnosed as burst appendix ). Three years remission following this unmonitored

Perforating small bowel Crohn's Disease 01/2016 (terminal ileum, duodenum)
Coeliac disease (age 26)

50mg azathioprine (down from 75mg after my WBC dropped)
Gluten-free diet
09-28-2017, 08:17 AM   #2
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I think it sounds like they don't want to express an opinion either way. With some luck, once these studies they mention are carried out and show that, yes, people DO flare if you take away the medication preventing them from flaring - perhaps the presence of more evidence (in the form of these studies) will allow the team behind funding to be slightly more thoughtful when considering whether or not to keep a patient on biologics, and not just think of the cost. Until then, it seems like CCUK don't want to be drawn into the argument without evidence.
Hi, I'm Emma!
19 years old.
Diagnosed: Crohn's disease, August 2007
Currently on: Humira 40mg fortnightly
09-28-2017, 10:02 AM   #3
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The arguments the CCUK are making are basically true to one degree or another, but the one big factor that pushes them to stop biologics that they conveniently fail to mention is cost.

Biologics are very expensive. So in an era of limited resources that will be a very big factor lurking in the background of every biologic start/stop decision.
09-28-2017, 10:06 AM   #4
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What a frustrating (written) conversation! They are clearly sidestepping your questions because they don't want to state outright that funding drives decisions. While I live in the US and have excellent insurance thanks to my husband, the same dialogue happens over here; the players are just different. At one point when I was unable to eat or drink because of an obstruction my insurance company denied inpatient coverage. The attending doctor (all without my knowledge; I got the correspondence from them after I returned home from my week's stay in hospital) had to appeal in order for me to be an inpatient. Obamacare prevents insurance denying coverage for pre-existing conditions, but the current administration wants to remove that and other important policy changes which would send us back to the dark ages in terms of public health.

I know funding is tight but it would be nice to get a straight answer from an organization that is supposedly all about research and information. If a biologic keeps a patient in remission why risk a return of symptoms which may become even more expensive to treat? Without treatment how many people would end up in hospital? Surely those costs are higher. I'm assuming treatment varies from region to region and GI to GI. Here in the US some doctors are more proactive about advocating for their patients than others. It would be nice to have guidelines that are patient-centered rather than cost-centered.
11-09-2017, 08:15 PM   #5
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You all have my support. That protocol is just plain garbage and it is seriously ruining peoples health.

Crohn's Disease Forum » General IBD Discussion » Correspondance with CC UK r.e use of biologics - thoughts?
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