Uma Mahadevan-Velayos, MD
Associate Professor of Clinical Medicine
Director of Clinical Research
University of California San Francisco Center for Colitis and Crohn’s Disease
Question:
My son is a 22 year old ,male, currently on Remicade, and has been for five years. I am very concerned with long-term effects such as lymphoma. Are the new drugs (Cimzia and Tysabri) a better option? What are the signs that Remicade is no longer working?
Dr. Mahadevan-Velayos:
The risk of lymphoma with anti-TNF agents such as Remicade (infliximab), Humira (adalimumab) and Cimzia (certolizumab) are thought to be similar as it is an effect of that whole class of drug. Switching from one to the other will not reduce that risk. The risk is estimated to be about 1/1000 patients. Tysabri (natalizumab) also has a risk of lymphoma and a 1/1000 risk of PML, which is a viral infection of the brain. Therefore it is kept in reserve for those who fail anti-TNF agents.
The signs that Remicade is no longer working are signs of active Crohn's or UC. Some patients will lose the length of their response and require dosing more frequently than every 8 weeks or at a higher dose (10 mg/kg rather than 5 mg/kg). For example, patients may experience increasing diarrhea and abdominal cramps for the two weeks prior to their infusion and then feel well after the infusion. They will be better able to feel well the whole time if they get infused every 6 weeks or at an increased drug amount every 8 weeks.
Question:
I was diagnosed with non-specific UC/Crohn's disease ten years ago. After a serious flare-up three years ago, I became dependent on prednisone, so my doctor recommended azathioprine (imuran) in order to wean off the steroids. The combination of imuran and a very low dosage of prednisone kept the disease in complete remission for one year. However, at the same time I had problems with severe nausea/vomiting, and my doctor recommended stopping the azathioprine. This then led to a very severe UC flare-up, but did not stop the nausea problem. I am no longer responding to prednisolone at all, and my doctor has recommended a colostomy. Due to a range of lifestyle factors, I really wish to avoid this surgery. Are there any viable, safe alternatives?
Dr. Mahadevan-Velayos:
Infliximab (Remicade) is FDA approved for the treatment of Crohn's disease and Ulcerative colitis. It is effective for outpatients who are steroid dependent or steroid refractory. This would be an alternative treatment that may be appropriate for you prior to considering surgery.
Question:
I have Crohn's pyoderma gangrenosum, many lesions. I do well with IV cyclosporine in the hospital but start to flare up when I am discharged. Can you give me any suggestions?
Dr. Mahadevan-Velayos:
Topical Tacrolimus (similar drug to Cyclosporine but applied directly to the skin) works for some PG lesions. Also, the anti-TNF agents (Remicade, Humira and likely Cimzia) have also been shown to be helpful. They are maintenance agents though so once you start, you should continue.
Question:
I have ulcerative colitis that is limited to the first 12CM of my rectum. I have had severe bleeding. My doctor is considering formalin injections as a last resort. What is your opinion?
Dr. Mahadevan-Velayos:
There are no clinical trials that show benefit of formalin injections for this indication. Options that may work include — suppositories of either Mesalamine (Canasa 1 gm daily or twice daily) or hydrocortisone, enemas of Mesalamine or hydrocortisone, hydrocortisone foam andbudesonide enemas are all topical therapies that can work. Alternatively, oral medication such as Mesalamine, Azathioprine/6MP and Infliximab (Remicade) are other options that have shown benefit.
Some patients are allergic to Mesalamine and have worsening symptoms when they take it. So if you get worse with Mesalamine suppository or pills, this may be why.
Question:
I had an abscess drained in the emergency room that they said was a horseshoe abscess with two incisions to pack and drain. Only one incision closed and the other is still open. Drainage is minimal and so is pain. It has been eight months and my primary care physician that it will heal on its own within a year and does not suggest that I get the surgery the specialists suggest. He says that I have a fistula about an inch and would need a fistulotomy with possible cutting seton. I do not have Crohn's or any other bowel disease.
Dr. Mahadevan-Velayos:
If you have a horseshoe fistula I would make sure an experienced gastroenterologist has completely ruled you our for Crohn's disease. Also, 5% of patients with Crohn's have disease limited to the perianal region alone without bowel disease.
You should also get an opinion from an experienced colorectal surgeon (not general surgeon) about what to do for your fistula. It would be worth the trip if you don't have one in your area as perianal disease like yours can lead to life long incontinence and other problems.
Question:
I am 28 years old and was diagnosed with UC sixteen years ago. I am 7 weeks pregnant and am starting to have a flare-up. I had been in remission for four months prior to this week, having waited to be well before trying to conceive. What are my options for treatment? Are there any doctors who specialize in treating pregnant women with active IBD? Currently the only medication I take is Lialda and I am terrified of the adverse effects other medications might have on the baby.
Dr. Mahadevan-Velayos:
The risk of flaring during pregnancy is similar to when you are not pregnant - about 33%. In most cases you would treat it the same way you would if you are not pregnant. Mesalamine agents such as Lialda are considered low risk during pregnancy. Prednisone is considered low risk though use in the first trimester may be associated with cleft palate. Azathioprine/6mp has also been used, but usually only if the patient was already on it prior to pregnancy. Infliximab or Remicade is category B.
This is a complex decision as disease flare can lead to negative pregnancy outcomes such as miscarriage and pre term birth. You should see an IBD specialist during this time. If they feel uncomfortable, they will be able to refer you to IBD doctors who specialize in pregnancy.
Question:
I have had Crohn's disease since 1998. I have a baby who is just a few weeks old. Is it safe to breast feed the baby? I am on Pentasa, two tablets three times a day.
Dr. Mahadevan-Velayos:
Mesalamine agents such as Pentasa are compatible with breastfeeding and most mothers can safely breast feed while taking these drugs. Rarely, the baby will develop bloody diarrhea as an allergic reaction. If this happens, either stop breastfeeding or stop the medication (which may lead to a flare) and the baby should improve within a week.
Question:
I read that Imuran is not an FDA approved drug to treat Crohn's disease. Is this true? If so, why have my doctors strongly suggested I take it to treat my Crohn's?
Dr. Mahadevan-Velayos:
Imuran has been around since the 1960's. At that time, drugs FDA approved for one indication could be used for other indications without much problem. To get a drug FDA approved takes a lot of money and large clinical trials and there is no motivation to go through that process for Imuran now. However, there is good data to show that it works for Crohn's disease and it has been used for this indication for 40 years with success.

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