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What do you guys think? It is specifically delivered to the pouch, you don't have to take antiobiotics and the trial below says 75% achieved remission.


http://www.medscape.com/viewarticle/557837

I haven't had the pouch surgery yet but for those of you suffering from chronic pouchitis, I thought this might help or be something to bring up with your doctor to see if it is an option.
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Oh weird. Here I'll copy and paste the majority of it below:



Background: Pouchitis is the major long-term complication after ileal-pouch nal anastomosis for ulcerative colitis. Ten to 15% of patients develop a chronic pouchitis, either treatment responsive or treatment refractory.

Aim: To evaluate the efficacy of oral budesonide in inducing remission and improving quality of life in patients with chronic refractory pouchitis.

Methods: Twenty consecutive patients with active pouchitis, not responding after 1 month of antibiotic treatment were treated with budesonide controlled ileal release 9 mg/day for 8 weeks. Symptomatic, endoscopic and histological evaluations were undertaken before and after treatment according to Pouchitis Disease Activity Index. Remission was defined as a combination of Pouchitis Disease Activity Index clinical score of ≤ 2, endoscopic score of ≤ 1 and total Pouchitis Disease Activity Index score of ≤ 4. The quality of life was assessed with the Inflammatory Bowel Disease Questionnaire.

Results: Fifteen of 20 patients (75%) achieved remission. The median total Pouchitis Disease Activity Index scores before and after therapy were, respectively, 14 (range 9-16) and 3 (range 2-10) ( P < 0.001). The median Inflammatory Bowel Disease Questionnaire score also significantly improved from 105 (range 77-175) to 180 (range 85-220) ( P < 0.001).

Conclusion: Eight-week treatment with oral budesonide appears effective in inducing remission in patients with active pouchitis refractory to antibiotic treatment in this open-label study.

Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) has emerged over the past 15 years as the surgical procedure of choice for the management of ulcerative colitis (UC). Pouchitis, a non-specific, idiopathic inflammation of the ileal reservoir, has become the most frequent long-term complication following pouch surgery for UC. [1] The reported incidence of pouchitis is largely variable because of differences in nature and duration of the follow-up and, particularly, because a myriad of diagnostic criteria have been used to define this syndrome. [2-7] Most patients who develop acute pouchitis do so within the first year, but some may suffer their first attack some years following surgery. [4]

This syndrome is clinically characterized by variable symptoms including increased stool frequency and fluidity, rectal bleeding, abdominal cramping, urgency and tenesmus, incontinence, fever and extraintestinal manifestation. [8] A clinical diagnosis should be confirmed by endoscopy and histology. The endoscopic features of pouchitis include mucosal erythema, oedema, friability, petechiae, granularity, loss of vascular pattern, erosions and superficial ulceration. Histological examination shows an acute inflammatory infiltrate with crypt abscesses and ulceration in addition to a chronic inflammation, including villous atrophy, crypt hyperplasia, which is almost universal and probably represent an adaptive response of the pouch mucosa to faecal stasis. [9] The absence of clear and universally accepted criteria for diagnosis, classification and definition of activity has determined a great variability in the results of reports on the incidence of pouchitis, and in the assessment of therapy. To overcome this problem, Sandborn et al. developed a Pouchitis Disease Activity Index (PDAI) ( Table 1 ). [10] This 18-point index is based on clinical symptoms and endoscopic appearance as well as acute histological findings, and represent an objective and reproducible scoring system for pouchitis. Active pouchitis is defined as a score ≥ 7 and remission is defined as a score < 7.

Treatment of pouchitis is largely empiric and only few small placebo-controlled trials have been conducted. Antibiotics are the mainstay of treatment, and metronidazole and ciprofloxacin are the most common initial approaches with a rapid dramatic response. [11-14] Ten to 15% of patients with pouchitis experience a chronic pouchitis either 'treatment responsive' or 'treatment refractory'. [8] Patients with treatment-responsive chronic pouchitis respond to therapy, but when the therapy is stopped, pouchitis relapses. Patients with treatment-refractory pouchitis do not respond to conventional available therapies, and continue to suffer symptoms. Anecdotal experiences have reported satisfactory results with oral and topical corticosteroids. [15,16]

Budesonide is a synthetic steroid with a high topical glucocorticoid activity and with low systemic bioavailability caused by a high first-pass hepatic metabolism. Controlled-ileal-release (CIR) budesonide is enteric coated and designed to deliver budesonide to the terminal ileum and proximal colon, where Crohn's disease is most common. In clinical trials, budesonide was superior than placebo and comparable with traditional steroids for the treatment of Crohn's disease, with fewer side-effects. [17,18] Budesonide enemas have been shown to be as effective as metronidazole in active pouchitis, in a double-blind, double-dummy trial, [19] and recently it has been suggested that the use of budesonide CIR may be effective in the treatment of acute pouchitis. [20] Based on this background, we hypothesized that oral budesonide could be a rational therapeutic option for patients with refractory pouchitis.

Aim of this study was to evaluate the efficacy of oral budesonide for treatment of patients with chronic refractory pouchitis, as well as its impact on their quality of life.
Pkitty,

I am taking budesonide (aka Entocort EC) as well as antibiotics. I have been on it since July. I am doing well, but the proof of the pudding will be when we compare my next scope results to my last scope results in June. Entocort is not a new drug. It is a designer steroid. The idea was to put out a drug achieving similar anti-inflammation properties as Prednisone without the nasty side effects. I do have less side effects with Entocort than I did with Prednisone.

We tried Entocort alone without antibiotics and I nearly had a blockage and had to go back on antibiotics. I am in a precarious situation with a narrowed bowel above my pouch and we were not in a position to attempt cold turkey again. Any worsening of my situation at the pouch inlet could lead to a blockage or a twisted bowel like Maurice Gibb of the BeeGees. Which killed him.

I am taking the same dosage as those in the study and have been since July.

By the ways, while your info is appreciated, you may want to delete the duplicative thread in the General Forum. The Moderator does not like duplicative threads.
Last edited by CTBarrister
CTBarrister - You unfortunately seem to have alot of experience with chronic pouchitis.
I've had my pouchitis for the past year and a half and have been through a run of cipro, flagyl, and xifaxin, all of which have stopped working.
Do you know what the next typical treatment or "level" of treatment *should* be to try? Are there more antibiotics to try? Am I going to end up back on steroids or the drugs I so detested while I had UC?
I live in hawaii and am waiting to receive some corticosteroid enemas from the mainland but the docs out here are sub par so I'm stuck doing some coordination right now until I can get back to the mainland for a pouchoscopy and appt. But I know it's the $&#*(@*&$ pouchitis.
Thanks for sharing your experience and any suggestions.
quote:
Do you know what the next typical treatment or "level" of treatment *should* be to try?


If rotating antibiotics have failed (you may also want to try augmentin and keflex), the other options are the aforementioned Entocort or the "biologics" (Remicade, Humira et al), which I have been told are the "last line" of treatment of pouchitis. Fortunately, I have not gotten there, yet.
Entocort (budesonide) isn't really new. It's been around for about 20 years, mostly for Crohn's though. The article posted is from 2007, so not really new for pouchitis, but definitely more recent for more common use.

It also comes in enema form for more targeted use.

But, being a steroid, they tend to want to avoid them, except for short term use, or when other options are not viable.

Jan Smiler

P.S. If you want to read Medscape articles, you do need to register, but it is free.
Jan, What problems have you heard of with long term Entocort use? I've had chronic pouchitis ever since my takedown 10 years ago, and my condition started slipping about 9 months ago. My GI put me on Entocort and it improved things for me, although not into remission. I tried to drop the Entocort a few months ago and my condition slipped back right away. What side effects do I need to be concerned about long term?
anything prednisone can do, so can Entocort. But, the good news is that it is less likely and takes higher dosing to occur. Still, it is one of those individual things and largely depends on your liver, since much of the good thing about Entocort, besides poor absorption, is the first pass liver metabolism, that keeps most of it from circulating systemically.

Jan Smiler
I have been taking Entocort since June and in 6 plus months of a 9 mg dosage and several weeks at 6 mg I have observed none of the side effects I had with prednisone. I don't know what the poster considers long term but it is 7 months plus now. I also have had a very good stretch of pouch function the past few months with no pouchitis flares.

If my body could handle 20 years of on and off prednisone which only left me with a little bit of osteopenia in the left forearm, I feel like I should be able to handle Entocort.
Just joined the group. Had my J-pouch since 1998 and have been battling pouchitis just about the whole time. I've been given all the different antibiotics but all of them stop working. Just got a scope last Friday at CC under care of Dr. Shen who is the best. He didn't like what he saw. Took me off Xifaxin and put me on Entocort. I'm worried that I'm heading towards pouch failure. Does Entocort work. I hope so!!!

Brian
brian just curious when you said all antibiotics stopped working ..did you ever try rotating them because any antibiotic seemed to stop for me too but when i started rotating them i have held my own for 3 years..not sure what future brings but thats it for now..so far i tended to stay on one until it began not to work and than moved to another in rotation..others switch on regular basis..

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