Dr. Brian Bressler, MD, MS, FRCPC (biography and disclosures)
What I did before
The treatment of Crohn’s disease has, for the most part up until recently, been centred on controlling clinical symptoms associated with this disease. The reason behind this approach is largely due to the fact that we did not have therapy that could change in a reliable way the inflammatory response leading to the abnormal function of the GI tract causing the symptoms of Crohn’s disease. A mainstay of treatment was Prednisone, as this does consistently improve clinical symptoms associated with Crohn’s disease. Unfortunately, it has been known that it has no impact on changing the natural history of Crohn’s disease, specifically a reduction in surgeries or hospitalizations. We have always known the side effects and toxicities associated with steroid use. What has become more concerning in recent prospective cohort studies has been an increase in mortality and infections in patients with Crohn’s disease exposed to Prednisone.
What changed my practice
As we have learned more behind the abnormal immunological response triggering inflammation associated with Crohn’s disease, medications have been developed to specifically address this problem. The most effective medications for treating Crohn’s disease are anti-TNF inhibitors. Infliximab and Adalimumab are the two medications in this class available in Canada. They have been shown, like Prednisone, to quickly induce clinical remission. Unlike Prednisone, they have also been shown to keep patients in a long-term clinical remission. The most unique result in the clinical trials evaluating these medications has been the ability of both agents to heal the bowel. We have known for a long time that, although Prednisone makes patients feel better, it has no impact on what the bowel looks like. It has always been assumed, but now it has been proven, that healing the bowel changes the natural history of this disease by reducing the need for surgeries, fistula formation and hospitalization. These medications have also shown the ability to reduce the requirement of Prednisone in patients with Crohn’s disease.
What I do now
A goal in treating patients with Crohn’s disease is to return their quality of life back to its normal state, with the avoidance of Prednisone. I counsel each patient when I first diagnose them with Crohn’s disease that in this era we are now more than ever able to effectively treat their Crohn’s disease to the point where it should have very little, if any, impact in their life. Effectively treating the inflammation in patients with Crohn’s disease has now allowed us to treat not just the symptoms associated with Crohn’s disease, but the disease itself. My take home message to anyone involved in the care of patients with Crohn’s disease is to refer patients with Crohn’s disease to a gastroenterologist to review their treatment plan if the patient’s quality of life is impaired by their symptoms attributed to this disease. Furthermore, when patients are doing well encouraging compliance for adhering to their treatment plan is important to maintain their quality of life.
References:
Rutgeerts et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease.Gastroenterology 2004;126:402-413
Rutgeerts P et al. Adalimumab Induces and Maintains Mucosal Healing in Patients with Moderate to Severe Ileocolonic Crohn’s Disease — First Results of the EXTEND Trial. Gastroenterology 2009;136(5 Suppl 1):A-116.
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This article was interesting in that I did not know that we could change the natural history of crohn’s with the new anti-TNFs.
Since it often takes several mos to access a gastroenterologist, when I start someone on an anti-TNf what would be rcommended re followup regarding side effects?
What about other long-term issues with this approach?
I totally agree with Dr. Bressler’s advise of referring Crohn’s patient for gastroenterological consultation. IBD is an ugly disease as it is lifelong and multi-system involvement and if not managed properly and well controlled can be very disabling and even life threatening.
I do worry about the potential longterm or future (unknown) side effect or complications from using the anti-TNF medications on these patients. It is trading the devil ( prednisone) we know for something unknown.
i agree with Dr Bresslers opinion.I would like some furthur input in to the long term use of anti-TNF,S.
Longterm effects of the anti-TNF medications and coverage are my main questions.The possiblity of changing the natural course of the disease is challenging.
For sure referring or re-referring a patient that suffers from Crohn’s disease will be my next step.
Given the novelty of anti-TNF drugs, their long term side effects is my main concern, not to mention the associated cost, once again likely secondary to their relatively recent introduction.
Very interesting article. What do these new drugs cost per month?
also concerned with the long term effects of anti-TNF meds, especially in the younger patients who may be on these for many years
It is very exciting to have something that will treat the disease itself ,not just the symptoms.I would like more specific details of the treatment and the possible side effects that we have to watch out for.
cost limits access,
selection criteria need defining
long term s/e of cancers concerning, especially young folk
How long does the patient stay on the treatment and what the costs involved? Does it work for ulcerative colitis?
As it stands now in BC pharmacare will only cover anti-TNF agents if prescription is written by Gastroenterologists. In general these medications are very well tolerated – infectious complications are the most relevant problem to consider.
Brian Bressler
* The major long term issue with this approach is understanding when we can stop these agents. The major drawback about stopping these drugs is antibody formation which means restarting agents may not work and lead to reactions. Currently we don’t have stopping rules but we are trying to understand in what clinical context we can do this.
* There is no comparison regarding prednisone and anti TNF agents. Prednisone is the most dangerous drug we use for Crohns disease – it is known to increase mortality (TREAT registry). Furthermore it has never been shown that prednisone can improve any important end points (surgeries, hospitalizations, mucosal healing). Anti TNF agents have been around for over a decade with close to 2 million people being on these drugs for Crohns disease. We are not seeing any new safety signals the longer we use these agents.
* We don’t have good stopping rules yet, we are trying to answer this question.
As long as the treatment is tolerated and working we continue the medications. The cost is approximately 25-30K per year.
Brian Bressler
No question about healing the bowel and all the potential good. Unfortunately, there are still significant potential side effects such as increased rate of shingles and the myriad of fine print side effects. A definite step in the right direction, but hopefully more research will find meds with even fewer side effects in the future. The price of these drugs is also astronomical.
Agree with all the above, and glad we have moved forward on healing the bowel with ongoing research into end points, managing and recognizing side effects. Can we ever get special authority?
I would like to know the inclusion criteria for patients with crohn’s disease to receive infliximab therapy.
I always refer patient to gastrologist
I have been on different TNF drugs for Crohn’s, and Ankylosing Spondylitis. I was on Remicade/Infliximab 16 years ago (as a tester). It worked really well for both the Crohn’s and Ankylosing Spondylitis for almost six years. I had my life back and was able to return to full time work. From there I went onto Humira and it worked well for three years. Then I went into a major flare and ended up with surgery. From there I have been on two different TNF drugs. One for Crohn’s and Ankylosing Spondylitis that helped the arthritis but did nothing for Crohn’s, so the trail of Orencia was stopped. From there I went on to another trial drug Vedolizumab that worked great for Crohn’s but not Ankylosing Spondylitis. So seeing how it was stopped I again am looking for surgery seeing how I now have a collapsed ielum. I am looking forward to taking another TNF after surgery called Golimumab. I am more than sure that these drugs are better for us than prednisone seeing how I now have osteoprosis due to the years of use of prednisone.