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Miguel Regueiro, MD

Associate Professor of Medicine
Co-Director, Inflammatory Bowel Disease Center
Director, GI, Hepatology, and Nutrition Fellowship
University of Pittsburgh Medical Center


Summer 2008

Question:
My daughter is six years old and has indeterminate colitis. She had been on Humira and Imuran 100 mg. She had been in the midst of a severe flare-up when she was placed on Humira, with almost immediate improvement (prior to that she had been on Imuran and Remicade) Since that time, although she has been feeling well, she has been having continuous blood loss. The contemplated treatment plan is to take her off Imuran and put her on oral Methotrexate and Humira in hopes of stopping the blood loss. Is there any information on the efficacy of Humira alone versus the combination of Humira and Methotrexate for IBD? Is there increased risk of adverse effects with such combination therapy? Is there any utility to folate administration in such a situation?

Dr. Regueiro:
The results of the pivotal studies evaluating the efficacy and safety of Humira for Crohn’s disease, did not show a difference in response between patients on Humira alone or Humira in combination with an immunomodulator (such as, methotrexate, 6MP, and azathioprine). Meaning, whether patients were on Humira alone or in combination with another immune agent, the benefit was the same. Most of the data on Methotrexate in combination with Humira comes from the Rheumatology studies in Rheumatoid arthritis. All of these patients were on the combination of these medications (unlike the Crohn’s studies). If you compare the safety data from the Crohn’s studies on Humira alone with rheumatology studies with Humira and Methotrexate, there did not appear to be differences in safety. Meaning, that the combination of drugs did not appear to increase side effects. Of course, every time we use an additional medication, there is the chance to get side effects from that medication. I generally give my patients folic acid 1mg to 2mg on the days that the person is not taking the methotrexate.

In your daughter’s case, assuming that the blood loss is coming as a result of active Crohn’s disease it is reasonable to add methotrexate. If the blood loss is due to something other than the Crohn’s disease then the methotrexate would have no impact.

Question:
I have ulcerative colitis and went off Colazal two years ago and use aloe vera capsules. I have some flare-ups when I don't eat correctly. My doctor wants me to stop this and get back on Colazal. I felt that it wasn't working and I was back to him every three months. I have felt so much better on aloe vera than I ever did on the prescription. How do you feel about taking an herb?

Dr. Regueiro:
Certain natural substances may benefit patients as a complement to their prescribed treatment. The difficulty is that we do not have scientific data on many of the natural compounds out there. Aside from Aloe, other natural agents that may have natural anti-inflammatory benefit include fish oil and probiotics. In my patients who feel well on non-prescription therapy, I use findings on colonoscopy to dictate therapy. Meaning if you still have signs of active ulcerative colitis on the colonoscopy then you should add back the Colazol.

Question:
My husband is 32 and had to go on prednisone for his ulcerative colitis seven months ago. It took him a long time to get off it and he has been off it since early October. Unfortunately he has had a flare-up for the past month. He is a podiatrist, so his schedule is not conducive for either rest or constant bathroom breaks. His doctor just put him back on the prednisone and upped his 6MP to 75 mg. I'm concerned about his being on prednisone again in such a short time, not to mention his diet is the most strict ever; everything plain, no dairy and just fish, chicken, steamed vegetables and plain egg whites. We are at our wits end and don't understand why the doctors treating him are avoiding the Remicade alternative. I think we need a better specialist in the NY/NJ area. Can you recommend one?

Dr. Regueiro:
Remicade is a reasonable option for ulcerative colitis that is still active despite prednisone and 6MP. Not every patient has to be on a strict diet. Patients should experiment to see whether specific foods increase symptoms.

There are many excellent IBD centers in the NY area, such as Mount Sinai Hospital and Cornell University.

Question:
I am a 46 year old female (5'3", 115 lbs) who was diagnosed nine years ago with ulcerative colitis affecting approximately 15 centimeters of the sigmoid colon. For many years I was able to remain in remission with diet and cortifoam. In the fall of 2005, the disease progressed and I have since been diagnosed with pancolitis/indeterminate colitis although my CT scan of the small bowel was clear. After months of misery on 5 mgs of prednisone (tapered from a high of 40mgs) combined with cortifoam and 1000 mgs of Pentasa per day I was ready to try something different. After reading several articles about the success of Rifaxamin, I asked my doctor to prescribe it for me. I have been taking four 200mg tablets per day with much success. I have been able to go off steroids and maintain remission. Can you tell me if Rifaxamin is safe for long term use. If it is, what would be an optimal maintenance dose? Is there any new information on the treatment of IBD with this drug?

Dr. Regueiro:
Rifaxamin is a non-absorbable antibiotic that does not appear to have any major long term safety concerns. Most of the studies on Rifaxamin in IBD have been short term (less than one year), however it is probably safe to use beyond one year. The optimal maintenance dose for UC is not known, but if you’ve done well on 800mg per day it may be reasonable to discuss with your doctor a slow decrease in your dose to 200mg two to three times per day; if you have a return of symptoms at a certain dose then you may need to hold at that dose or the next higher dose.

Question:
I have ulcerative colitis. I am currently on Pentasa 500 mg, two capsules 4X/day and 6MP 50 mg daily after my last flare in 2005. I would like to try Lialda to try and further cut down the number of pills per day. I have tried all the other medications already. I noticed all the information on Lialda says it is to induce remission. As I am already in remission, and can it be used for long term maintenance also?

Dr. Regueiro:
Data on remission with Lialda has not yet been released but from research presentations it appears to also be effective as a long term maintenance medication. Therefore, it would be reasonable to use Lialda for maintenance of remission.

Question:
I am a typical Crohn's patient who has taken Azathioprine for four years. As Azathioprine does not work for me any more, I plan to switch to Humira shortly. How long can I stay on Humira? Also, having two ulcers in the terminal ileum and mild arthritis, should I try to be re-diagnosed or it is absolutely certain that I have Crohn's disease? There have been short periods of remission without any medication and I have no weight loss.

Dr. Regueiro:
Humira has been effective for the induction and maintenance of remission in active Crohn’s disease. Although the initial studies only reported results of people on Humira up to one year, there are emerging data to support its use beyond one year.

Regarding the correct diagnosis of Crohn’s disease ulcers in the ileum fits with a diagnosis of Crohn’s disease. If you want to know if the diagnosis is secure I’d suggest consulting with your physician to find out how the diagnosis was made, i.e. biopsy specimens, x-rays or a combination. Usually if there are ulcers in the ileum and the biopsies show active inflammation and changes consistent with Crohn’s disease, then that’s the correct diagnosis.

Question:
My Mom has been suffering with IBD for a few years now and is house bound. She has always been an outdoor person but her cramps and pain are not tolerable. She in on Bentyl but its help is minimal. She cannot ride in the car because that particular position make her cramps worse. Now I am watching my Mother, only in her 50s, waste her life away in her house. We need a super-specialist in Northern California.

Dr. Regueiro:
There is an excellent IBD center at UCSF with experts in Crohn’s disease and ulcerative colitis.

Question:
I am a 47-year old healthy male who started showing symptoms four years ago. I have received two different opinions; that I have IBS or IBD. Doctor number one who did a colonoscopy said it showed a healthy colon and bleeding was due to hemorrhoids and concluded I have IBS. He did not do any biopsies or go into the terminal ileum. Doctor number two conducted a barium x-ray which showed that the fluoroscopic spot image of the terminal ileum was normal. At my suggestion he performed a stool study which showed a few leukocytes in one test and many on another. He wanted to put me on Asacol right away, which I refused until I have a clear diagnosis. I would like to know how I can exactly find out if perhaps I have microscopic ulcerative colitis or Crohn's.

Dr. Regueiro:
Inflammatory bowel disease, which includes Crohn’s disease and ulcerative colitis, is “macroscopically” evident on endoscopic testing. That is, both diseases are visually apparent by evidence of ulcers and inflammation on colonoscopy with inspection of the colon and ileum. There is an entity of microscopic colitis, which includes collagenous colitis and lymphocytic colitis, which causes diarrhea but the colonoscopic inspection of the mucosal lining of the colon and intestine appears normal. The diagnosis of microscopic colitis is made by histopathologic inspection of biopsies taken during colonoscopy. If you had a colonoscopy with inspection of the colon and ileum with normal biopsies then it is unlikely that you have ulcerative colitis, Crohn’s disease or microscopic colitis. Leukocytes in the stool are nonspecific and while they can appear in the setting of IBD and infection, they are nonspecific and can present in people without IBD.

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Miguel Regueiro, MD

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