Doesn't make sense

Pentasa has been proven to reduce the chance of recurrence, specifically after resections. Pentasa is hardly absorbed systematically, it's probably not worth taking the risk. Are you on any other meds to help prevent recurrence? Have you discussed this with your GI?

There was a time when CDers didn't have any real med options after surgery, and they often got sick again. Nowadays we have a few options.

Good luck!

What were your symptoms on pentasa? Maybe you should try switching to something different and hopefully a little less expensive.

Roni, respectfully, you are incorrect about Pentasa. It has not been proven to reduce the chance of recurrence after resections.

Early studies indicated that might be the case, but as more data came in, the results clearly showed no benefit whatsoever from Pentasa or other 5-ASAs. As a leading IBD researcher said last year at a conference I attended: "We used to say the jury was still out regarding the use of mesalamines in treating Crohn's. The jury is now in, and the conclusion is that they are useless." (I'm paraphrasing, but it was that strongly worded.)

Roni, that was the initial thinking (from several years back), but it was made quite clear at the conference that there is no use for mesalamines in any type or location of Crohn's disease. End of story, no grey area, etc.

I'm not trying to be blunt; I'm trying to portray just how bluntly the researchers put it. Even some of the docs in the audience were skeptical, but the researchers were adament that 5-ASAs are completely useless in treating Crohn's.

Well, it's more than just heresay. I was there. I heard them say it, and I saw the studies they referenced. They've been saying it for several years now, and they have been showing the studies to back it up at the conferences. Some of those studies have been published; some had not yet been published. I have the references at home. If I remember to do so, I'll get them tonight.

thanksclindamcyin, I suggest you talk with your GI about the efficacy of your treatment, especially if you are still sick.

One thing we know for sure is that there are newer and older studies (90s and 2000s) on the internet that suggest 5-asa's do work, especially under the right circumstances and even in combination with other meds. They don't seem to work well for everyone though, and apparently remicade after resection works better (according to one small study I saw with only 8 people on the remicade). All I did was google, "Pentasa efficacy after resection." I didn't look at them all, only about 3 of the more recent studies from 2000s and a couple of the older ones from the 90s.

beave, a study that shows pentasa is ineffective does not nullify a study that shows it is effective. That is probably why this matter is a little controversial with some doctors. While the doctor you spoke with is convinced, others aren't. It takes a while to prove something one way or another. I find very few studies on google that question the efficacy of pentasa (mostly after resection), compared to some studies that show it has at least some efficacy after resection. Did you find the article/study/info from the convention? Would be interesting to read. Cheers!

Roni, no need for the disclaimer. My doc has already told me he may pull me off of mesalamine because "there's no evidence it is beneficial". I didn't know why he had come to that conclusion but you've just explained it.

He's a buy the book kind of guy though so I doubt he has kept me on it for this long unless the manufacturer has sold it as a Crohn's management option. If that's the case it and it turns out the manufacturer knowingly oversold the drug's benefits for that condition all this time then how could that not be fraud.

In An Evidence-Based Systematic Review on Medical Therapies for Infl ammatory Bowel Disease by Nicholas J. Talley , MD, PhD, FACG 1 , Maria T. Abreu , MD, FACG 2 , Jean-Paul Achkar , MD, FACG 3 , Charles N. Bernstein , MD, FACG 4, Marla C. Dubinsky , MD 5 , Stephen B. Hanauer , MD, FACG 6 , Sunanda V. Kane , MD, MSPH, FACG 7 , William J. Sandborn , MD, FACG 8 ,
Thomas A. Ullman , MD, FACG 9 and Paul Moayyedi , MB, ChB, BSc, MPH, PhD, FACG 10 for the American College of Gastroenterology IBD Task Force [SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg] published in Am J Gastroenterol 2011; 106:S2 – S25; doi: 10.1038/ajg.2011.58

on inducing remission with 5-ASAs: "...Overall we recommended against using 5-ASA to induce remission in active CD. Th e reason for this was that the data were equivocal and this did not include the Crohn’s III trial (160) involving 310 patients. Data on CD remission or improvement were not available for this trial, but the mean CDAI scores were similar between 5-ASA and placebo arms (160), suggesting that this trial is likely to be negative. Given that this trial represents 33 % of all the patients in the meta-analysis, we felt that it was likely that 5-ASA was not effective at inducing remission in active CD. 5-ASA therapies are likely to be maximally eff ective in the colon and yet the majority of patients in the studies analyzed had either ileal or ileocolonic disease. Th equality of evidence was categorized as low as there was only one trial (159) with low risk of bias, results were heterogeneous, and conclusions were different depending on what outcome measure was chosen."

on maintaining remission with 5-ASAs: "There were 16 RCTs (155,159,161 – 174) assessing 2,496 patients comparing 5-ASA with placebo or no therapy in quiescent CD for 6 to 48 months. The majority of patients had ileal or ileocolonic disease and there was no signifi cant diff erence in relapse rates between the two groups. The overall relapse rate was 56 % with 5-ASA therapies and 57 % in the control group (100). In the 11 trials that evaluated mesalamine, there was a trend toward benefit of 5-ASA, but this was not statistically significant (100). There were only three trials (155,165,170) that had low risk of bias and a subgroup analysis of these studies suggested a small but statistically signifi cant benefit of 5-ASA at preventing CD relapse (NNT = 13; 95 % CI: 6 – 100). Th e evidence was of low quality as there was a paucity of trials that had a low risk of bias, there was unexplained heterogeneity between studies and conclusions differed in those with unclear vs. low risk of bias. Overall the evidence available was not sufficient to recommend 5-ASA therapies to prevent CD relapse. Unlike the recommendation of the Cochrane review (91), we concluded that further trials might
be helpful in determining whether 5-ASA therapies have a role in colonic CD."

and from the concluding paragraph: "These data highlight that there are a paucity of options for patients with mild CD who require maintenance therapy...."

I brought in my copies of the presentation slides from last year's conference.

Kazbern's posts cover some of what I was going to say, so I won't repeat that. Thanks Kaz for posting that.

As we know, there have been several studies over the last 10-15 years that have shown possible benefits from 5-ASAs in treating Crohn's. Roni mentioned specifically one showing benefit post-resection. But each and every one of those studies had insufficient numbers of patients to be meaninful. For example, if a trial has 50 people, and 25 take placebo and 25 take a 5-ASA, what are we to make of the results if 7 of the 25 placebo patients improve while 8 of the 25 5-ASA patients improve? At first glance it might appear the 5-ASA is better than placebo, but statistically speaking, it's not so.

So in the last couple of years a few researchers have done meta-analysis, where they combine multiple, small studies into one bigger study.

For one example, for post-op use of 5-ASAs, see "Ford, et al, American Journal of Gastroenterology 2010" (that's all the reference I have - I don't know whether it's online or not). This particular meta-analysis looked at 11 trials with a total of over 1000 patients.

But there is another complicating issue now: Some of the trials used a clinical definition of relapse; some use radiologic evidence; and other trials used clinical and endoscopic. The meta-analysis showed no benefit whatsoever in 5-ASA use in the trials that used clinical and endoscopic evidence to define relapse. There was a small benefit to 5-ASAs seen in the trials that defined relapse only by clinical presentation (ie, "how do you feel?").

Based solely on that, people might think, well, it's worth taking 5-ASAs just in case. But the "number needed to treat" was 13 (number needed to treat being defined as the number of patients needed to be treated to prevent clinical relapse in ONE patient). Again, people might think if it helps 1 out of 13, that it's worth trying. But keep in mind these things: One, these drugs, especially the newer formulations, are expensive. There may be millions of dollars in the US spent on these meds for Crohn's patients. Two, the possible benefit required full dosing taken consistently, but one of the biggest hurdles in treatment is getting patients to take meds consistently, especially with 5-ASAs. Studies have shown most people do not take them consistently. Finally, these drugs are not without risks entirely. While less risky than other treatments, granted, it is estimated that 1/20 to 1/25 people will have a serious adverse reaction. So is it worth using these meds for a 1/13 chance of clinical improvement, no chance of endoscopic improvement, and a 1/25 chance of serious adverse event?



A second meta-analysis was published by AK Akobeng and E. Gardener in the Cochrane Database Syst Review, 2005 (again, I don't have it online). It showed no meaningful maintenance benefit for 5-ASAs.

Post Edited (beave) : 5/31/2012 5:43:50 PM (GMT-6)

Thanks for sharing that beave.

One thing I find interesting is that it also doesn't work well if the patient doesn't take it regularly. I take my pentasa regularly, and I can understand why it wouldn't work well if people skip doses, since it breaks open and coats the intestine in a certain area and the coating probably doesn't last for more than a few hours.

It's hard to say how much it's been helping me all these years, but I won't be stopping just to find out. I will take whatever relief I can get, even if it's a teeny amount. All the small amounts of relief add up to something better than nothing.