mesalamine / 5-ASA drugs

so last saturday i went to the CCFA's san diego chapter 8th annual education seminar thingy. imho, the most important thing i learned was concerning the use of mesalamine (aka 5-ASA drugs, like pentasa, asacol, colazal, etc). turns out the data shows that they work well for UC, but they are no more effective than a placebo in crohn's. wow. and i heard this from 2 different GI's at independent lectures and they dont work with each other nor at the same hospital.

it makes sense to me cos i was this this stuff for years (i took 4 out of the 6 mesalamine class drugs) and i never felt any of them did anything for me. i never noticed a dose response. however i took these drugs for like 14 years cos my docs told me to. i only stopped taking them late last year as i had stopped fosamax a month or two earlier (bone scan showed i was pretty close to normal after being on that drug for like 11 years) and i was going to stop taking 6-mp as i suspected it was causing my anemia, so i figured i might as well stop the colazal too. glad i did now that i heard this news. i am not bitter or upset for being told to take them and not being told that they dont really work in crohns - who knows who will respond to the drug or benefit from a placebo effect? i am just kinda miffed at the money i spent on these drugs. i did a quick estimate and it is close to 3 grand (usd).

i am NOT advocating you stop taking these drugs if you are taking them. always consult your doctor before you do something so rash. all i am doing is relaying information i gleaned from two different GI's (and they backed up this claim with statistical data) and how it relates to my personal experience. if these drugs work for you, i would recommend continuing their use. feel free to bring this up to your doctor, but dont be surprised if what i have stated here is dismissed out of hand. so use your best judgment, combined with the advice and care of your doctor, if you choose to continue using these drugs or stop taking them.

CH, this is interesting and it comes at a time when my son tells me he wants to stop Asacol. Don't worry, we won't do it without talking with his doctors. He feels it is doing nothing, though, and has felt that way for some time. Any idea how I could get my hands on the data you saw cited?

Fitzy, does the FDA (or whomever is responsible for these decisions) ever "un-approve" a drug for a specific condition? Especially one that's been approved and used for 60 years (that's what we were told about Asacol) for the treatment of a specific disease. I truly don't know and am curious...does this ever happen with an otherwise "safe" drug?... anybody?

All I take is Asacol for my Crohns. And I like Fitzy know if I miss my medicine, I will feel worse. So I personally don't agree with their thoughts on the 5-ASA meds. I also have a co-worker who only takes Pentasa to control his Crohns.

no way can i get my hands on this data. you'd have to be an MD. best chance is to ask your own doctor. sorry.

when i said i didnt think of the drugs was working, they said ok let's try this other one. the only real difference is the delivery mechanism and binders and fillers cos they all have the same active ingredient.

let me restate one point: the docs stated that it is no better than a placebo effect, but that does not mean that some people wont benefit from taking it and are legitimately receiving treatment and relief from it.

I heard the same thing at the Chicago CCFA conference. The GI at the conference did say they can work with some CD people if the disease is more in the colon.

Personally they don't seem to help me either and it makes no difference if I miss one. BUT they do have other benefits, like reducing the long-term risk of cancer. I think there are other side benefits too. Not that it necessarily makes up for the cost and annoyance of so many pills. But that is keeping me from stopping for now.

I believe I read the studies about the 5-ASA not being effective for Crohn's in one of the articles on the following website:

http://www.thecdwg.org/

I spend a lot of money on my Pentasa, and worry A LOT about whether it actually helps. Crohn's is a disease that can go in and out of remission on its own, so it gets very confusing. I seem to be slowly getting better, so I'm not ready to move on to the immuno-suppressives, but it does make me wonder all the time if I'm doing the right thing!

[*I just activated the link - C2]

Post Edited By Moderator (CrohnieToo) : 4/26/2008 8:18:41 AM (GMT-6)

As I understand it the 5ASA drugs are topical anti-inflammatories and work better in the colon than in the small bowel. Since most Crohns patients have primarily (or at least commonly) small bowel involvement, even when they have clear inflammation and ulcerations in the colon, using 5ASA for Crohns is basically only treating the bottom half of the diseased area and doesn't do a lot for symptoms. It has also been explained to me that the 5ASA drugs tend to "turn on" through some interaction with normal bowel bacterial flora, which live primarily in the colon. Hence these drugs really aren't going active at the levels you would want until they pass through the terminal ileum into the cecum. Hence, the feeling by many GIs that they simply aren't very effective in Crohns unless the disease is pretty much confined to the colon.

I have read the clinical studies on this subject. The placebo-controlled studies of mesalamine/5-ASA drugs in inducing and/or maintaining remission from Crohn’s have had mixed results, but the majority have found that they are no more effective than a placebo. Many doctors continue to prescribe them anyway because they are relatively safe drugs and the occasional person with Crohn’s seems to do quite well on them.

Someone asked whether they might be “unapproved” by the FDA. This is not an issue, because they were never approved by the FDA for use in Crohn’s disease. They were approved for use in ulcerative colitis and can only be marketed for that use, but doctors can prescribe them for any use (this is called off-label prescribing).

Off label use of drugs is a very common thing. Many drugs are approved for one use, and are then found to be useful for other conditions. Sometimes a company will go ahead and applied to the FDA for an additional indication for its drug. But often they don’t bother, because it is very expensive to do additional studies and go through the application process, especially if it’s not clear if the drug will be effective.

Fitzy,

Off-label use is a sticky issue. For practical reasons, most insurance companies will pay for generally accepted off-label uses. Otherwise many patients would be left without coverage for their medications. For example, neither 6-MP nor Imuran has ever been approved for use in Crohn's. (And if anyone's been marketing Asacol to people with Crohn's, they're going to be in trouble soon with the FDA. It only carries an ulcerative colitis indication.)

Generally insurance companies reject coverage for off-label indications when a drug is very expensive, and there is no clinical trial data proving that the proposed off-label use is effective, or proving that it is significantly more effective than using an approved drug.

I stopped Asacol last year after an eleven year stint of it. I was having symptoms that turned out to be side effects of the drug, so I'm better off without it. I really don't know if it ever worked on me. My disease is mostly in the colon.

This information came out a while ago as I know I've read it somewhere, possibly at the CCFA site.

It so hard to know what to do when it comes to this disease.

belleenstein said...
I find it really interesting that there is all this talk about the ineffectiveness of 5-ASA's recently. How long have salofalk and pentasa been on the market? I'm thinking since around 1986-88? Is it possible that they are getting close to the end of their patent protection.

Interesting theory, and plausible. Patent protection for drugs is indeed 20 years.

I seem to recall reading a while back that one of the main benefits of taking 5-ASA drugs was to prevent colon cancer, which Crohnies are susectible to.

Sorry to all that I haven´t been active in this forum for awhile, but I´ve been traveling and not always able to get online.

all the best,

Robert, currently in Costa Rica

Neither Pentasa nor Lialda had any effect on my CD. I honestly don't know why I'm still wasting money on the Pentasa.