Inflammatory Bowel Disease

Discussing the latest advances in Crohn’s disease and ulcerative colitis

July 24th, 2014 · Leave a Comment

Anti-TNF Therapy and Remission in Pediatric Crohn’s Disease

By Margaret Shepard

Jeanne Tung, M.D., discusses a recently published article in Pediatrics about anti-TNF drug therapy and remission rates in pediatric Crohn’s disease. This study was conducting using the ImproveCareNow database.

 

The ImproveCareNow registry was started in 2006 with the idea of improving care in pediatric GI centers. Mayo Clinic joined ImproveCareNow in 2011 and there are now over 60 participating centers across the United States. When IBD patients visit the doctors office, information about their visit is entered into the central database. This includes information about the type of IBD, medications, blood work, height, weight, and Crohn's activity score. An update is sent to a doctor each month about their IBD patients, including an alert if a patient isn't doing well. This can include if a patient isn't in remission, still on steroids, or if a drug dose isn't quite correct.

For the purposes of this study, the researchers look at patients in the database who had Crohn's disease, had moderate to severe activity, started on Remicade or Humira, and had been followed for at least one year in the registry. The researchers were able to identify 603 patients. The identified patients were compared to patients receiving Azathioprine, 6-Mercaptopurine, or Methotrexate.

Using this registry, mock clinical trials were created. The researchers calculated whether patients went into remission and whether they were able to stop steroids. The calculations were based on their Crohn's disease activity. The results found that more patients taking Remicade or Humira were in remission compared to those on Azathoprine, 6-Meraptopurine, or Methotrexate. To be exact, in six months remission was achieved in 54% of patients on anti-TNF agents compared to 41%. In 12 months, remission was achieved in 67% of patients on anti-TNF medication compared to 56%. These results were similar to clinical trial results for adult and children on Remicade.

The results show anti-TNF medication is better for pediatric IBD patients than Methotrexate in inducing remission. This study indicates that using the ImproveCareNow database can be helpful in answering other medication questions.

Clinical trials are still important. In this study, the researchers didn't examine how patients were growing, didn't include blood work to verify remission, and didn't conduct a colonoscopy to verify the tissue was in remission.

For more information on ImproveCareNow, visit ImproveCareNow on Facebook and Twitter.

Read the full study online here.

For more information on IBD, visit mayoclinic.org/ibd.

Dr. Tung is a pediatric gastroenterologist at Mayo Clinic.

Tags: Crohn's disease, drug therapy, Improve Care Now, Jeanne Tung, pediatric crohn's disease, pediatrics, remission

July 17th, 2014 · Leave a Comment

Treat-to-Target Therapy in Crohn's Disease Patients

By Margaret Shepard

Do have Crohn's disease and are wondering if your treatment therapy is working? Sunanda Kane, M.D., discusses a recently published article in Clinical Gastroenterology and Hepatology about treating to target Crohn’s disease.

 

The researchers, from the University of California at San Diego, previously published a paper on treating-to-target ulcerative colitis. Treating for intestinal healing is the most effective way of getting patients in remission and feeling the best they possibly can.

What does this mean? A patient may be on a biologic, still have diarrhea, abdominal pain or unable to gain weight but feel well. It could be beneficial to look at the intestinal tissue with a scope to see if the therapy is doing the most it can for the patient. With all the biologics to treat Crohn's disease, it is possible to check blood levels and increase the dosage to target healing of the tissue. Any presence of inflammation or ulcers may contribute to continued symptoms. The goal should be treating to heal.

The expectation is that intestinal tissue can heal. While it may be uncomfortable to undergo colonoscopies, it's helpful in the short term and long term for treatment of the disease.

Read the full study online here.

For more information on IBD , visit mayoclinic.org/ibd.

Dr. Kane is a gastroenterologist at Mayo Clinic.

Tags: Crohn's disease, Sunanda Kane

July 10th, 2014 · Leave a Comment

Cancer Risk Greater in Crohn's Disease Patients Treated with Combination Drug Therapy

By Margaret Shepard

John Kisiel, M.D., discusses a recently published article in Gastroenterology about the combination therapy of adalimumab and immunomodulators and the risk for cancer in patients with Crohn’s disease.

 

Recent studies have shown greater benefit when combining anti-TNF drugs with thiopurine drugs. Doctors have known for awhile that certain thiopurine drugs raise the risk of certain types of cancer, such as nonmelanoma skin cancers and lymphomas. It's important to know that the risk for cancer is small and the combination of drugs is the best strategy to treat Crohn's disease.

Dr. Osterman and his colleagues recently conducted a study of nearly 1,600 patients that were treated with adalimumab in clinical trails that led to the approval of that drug for ulcerative colitis and Crohn's disease. They measured the risk of cancer in a follow up, about a year and a half on average for each patient, and looked to see if patients were taking another immunosuppressant during the time they were on adalimumab. The researchers compared the rate of cancer in those patients with the general population using the SEER database, which measures the incidences of cancer throughout the United States for the general population.

The researchers found that roughly 34 of the 1,600 patients developed a cancer after participating in the study. That's roughly 2%. The risk of cancer was nearly three times higher in those taking the immunosuppressant with adalimumab compared to the general population. The risk of cancer in those patients taking adalimumab alone was not increased compared to the general population. Most of the cancers were nonmelanoma skin cancers. It was also interesting that the combination therapy had a higher risk of other cancers, such as breast and colon cancer.

It's important to remember that the combination therapy still has incredible benefits over using either drug alone.

The information in this new study is important for doctors and patients in terms of counseling about skin cancer and other cancers, including monitoring and prevention. Specifically, a patient should avoid suntanning, strictly avoid tanning beds, wear high SPF sunscreen, hats and long sleeves, and schedule an annual exam with a dermatologist.

Read the full study online here.

For more information about IBD, visit mayoclinic.org/ibd.

Dr. Kisiel is a gastroenterologist at Mayo Clinic.

Tags: adalimumab, AGA, cancer, Crohn's disease, Gastroenterology, John Kisiel, nonmelanoma skin cancer

July 1st, 2014 · Leave a Comment

FDA Approves Entyvio to Treat Ulcerative Colitis and Crohn’s Disease

By Margaret Shepard

Edward Loftus Jr, M. D., discusses the recent FDA approval of Entyvio to treat ulcerative colitis and Crohn's disease.

 

Entyvio represents a relatively new class of medications for inflammatory bowel disease (IBD). It's a biologic drug containing an antibody against the molecule alpha 4 beta 7. This is a targeted biologic for blood vessels in the gut to block white cells from leaving the blood vessels therefore causing less inflammation. This has been studied in a large population of patents with Crohn's disease and ulcerative colitis.

In the phase three studies of this drug, most of the primary end points were met. This includes remission response and steroid-free remission. It was seen during the studies that Entyvio may have a more favorable safety profile than some of the anti-TNF molecules.

There were some concerns that a parent molecule could cause a neurologic condition called progressive multifocal leukoencephalopathy. The rare side effect that occurs with the parent molecule does not occur with this molecule.

This drug is given as an IV infusion, like Infliximab, so it is necessary to go to a hospital or infusion center to receive it. It takes about 30 - 60 minutes to infuse. The first three doses are close together at 0, 2, and 6 weeks and then it is given every 8 weeks. This will be another nice option to have for patients who haven't responded to other drug therapies.

For more information on IBD, visit mayoclinic.org/ibd.

Dr. Loftus is a gastroenterologist at Mayo Clinic.

Tags: Crohn's disease, Edward Loftus, Entyvio, FDA, ulcerative colitis

June 27th, 2014 · Leave a Comment

Exclusive Enteral Nutrition and Pediatric Crohn’s Disease

By Margaret Shepard

Jeanne Tung, M.D., a pediatric gastroenterologist at Mayo Clinic, discusses a recently published article in Alimentary Pharmacology & Therapeutics about exclusive enteral nutrition (EEN) in pediatric Crohn’s disease. The results show EEN was associated with remission for pediatric Crohn’s disease.

 

What is EEN? For several weeks to months, a patient drinks formula such as Pediasure, Ensure, or Boost, instead of eating a regular diet. They gradually return to a regular diet. Sometimes patients find it hard to drink the number of cans or boxes of formula they need for that day so they learn to place a feeding tube down. A feeding tube is a way to avoid using steroids during flares. Steroids have side effects such as suppressing the immune system, causing weight gain, moodiness, and osteoporosis.

In studies of adult Crohn's patients, EEN didn't work as well as steroids. This may be due to patients dropping out of the study because they didn't like the taste of the formula. In the pediatric population, patients are more likely to use tube feedings so they don't have to taste the formula. In pediatric studies, the formulas worked as well as steroids, without the side effects. Compared to steroids, studies have shown mucosal healing, which means improvement in the tissue. Studies have also shown improvement in inflammatory markers such as the sed rate and c-reactive protein.

In this current study, researchers at a children's hospital in Germany looked at their experience with EEN for pediatric Crohn's disease.  The main purpose was to look at how effective EEN was in newly diagnosed Crohn's patients and those who used it during a relapse. The researchers looked back at their records for children with Crohn's disease that had received EEN. They excluded patients that either received steroids in the last three months or taken an anti-TNF agent, such as Remicade, Humira, or Cimzia.

To judge if the patients responded to EEN, they used an activity index designed for pediatric Crohn's disease. They also measured blood levels of inflammatory markers and checked stool samples. The researchers identified 52 patients to follow for at least a year and up to six years.

After EEN, 92% of the patients were in remission. There was modest weight gain and sed rates became normal. Some of the patients went onto a second period of EEN when the Crohn's disease flared. In that second period, fewer patients, 77%, were in remission 12 weeks later. In the group of patients that were just diagnosed, about 2/3 of them were on Azathioprine or 6-MP and were in remission one year later and stayed in remission when followed out to six years later. The researchers did notice about 40% of patients within six years still had to go on an anti-TNF agent. In this study, younger patients seemed to do better.

EEN was highly affective at inducing remission in children with newly diagnosed Crohn's disease. It was not as effective for patients who had a flare. EEN doesn't replace the typical medication such as Azathioprine, Methotrexate, or Remicade. It's meant to replace steroids and side effects.

Look for a more detailed video on EEN in the future.

Read the full study online here.

For more information on IBD, visit mayoclinic.org/IBD.

Dr. Tung is a pediatric gastroenterologist at Mayo Clinic.

Tags: Crohn's disease, EEN, exclusive enteral nutrition, Jeanne Tung, pediatric crohn's disease

June 19th, 2014 · Leave a Comment

Clinical Trials and IBD

By Margaret Shepard

Have you ever thought about joining a clinical trial? Many patients have benefited from participating in clinical trials. Edward Loftus Jr., M. D., discusses the pros and cons of entering a clinical trial for new drugs for patients with inflammatory bowel disease (IBD).

What are the pros?

  • Might get access to a drug years before it becomes commercially available.
  • Watched by medical providers more carefully. Patients in clinical trials tend to do better regardless if they are on the controlled drug or placebo.
  • The study tests and procedures are usually paid for by the sponsor of the trial.
  • Many trials are very patient friendly.

What are the cons?

  • People don't like feeling like a guinea pig.
  • Logistics of the study center.

For more information on IBD, visit mayoclinic.org/ibd.

Dr. Loftus is a gastroenterologist at Mayo Clinic.

Tags: clinical trials, Edward Loftus, IBD

June 13th, 2014 · Leave a Comment

Corticosteroid Use in IBD Patients

By Margaret Shepard

Edward Loftus Jr., M.D., discusses a recent article published in Inflammatory Bowel Diseases about early corticosteroid use in inflammatory bowel disease (IBD) patients. The results show that heavy, early use of corticosteroids is a strong predictor of disease severity.

The study took place in Manitoba, Canada and used the provincial administrative health claims data. The patients in the study were diagnosed between 1984 and 2010. In order to be considered an IBD patient, the patient needed to make at least five medical claims. If a patient was in the data base for less than two years, he or she only needed two claims. There were over 5,000 patients in the data base and it was roughly 50/50 ulcerative colitis to Crohn's disease. The researchers were interested in looking at, at any given time, how many steroids was a patient on. The researchers were also interested in heavy steroid use which was defined as over 3,000mg cumulative over a 12 month period and the patients outcome with respect to surgery.

The researchers found the peak point prevalence for corticosteroids was about 60 days after diagnosis of IBD. At that point in time, 17% of the patients were on corticosteroids. After that time period, the point prevalence rapidly declined. If you did have a high dose corticosteroids within the first year, the rate of needing surgery was significantly higher.

The results tell physicians they can use steroids as a prognostic risk factor. The early use of corticosteroids general means the patient is going to have a higher risk of an adverse outcome, such as surgery. Does that mean steroids are making the condition worse? Probably not; it is probably a marker more severity. This study highlights the fact that early need for steroids is in fact a risk factor.

Read the full study online here.

To learn more about IBD, visit mayoclinic.org/ibd.

Dr. Loftus is a gastroenterologist at Mayo Clinic. 

Tags: Canada, corticosteroid, Crohn's disease, Edward Loftus, IBD, steroid, ulcerative colitis

June 5th, 2014 · Leave a Comment

Etrolizumab and IBD

By Margaret Shepard

Edward Loftus Jr., M. D., discusses a recently published article in The Lancet about the phase two trial of Etrolizumab, which is a drug for patients with moderate to severe ulcerative colitis.

 

The molecule of this drug is an antibody directed at a substance called beta seven integrin. Integrins are molecules that act with adhesion molecules allowing white cells to leave the blood vessels, enter the soft tissue, and cause inflammation. Beta 7 integrin is found on molecules α4β7 and αEβ7. These molecules interact with two different adhesion molecules called MAdCAM, which is found in the gut, and E-cadherin, which regulates the white blood cells to leave the blood vessels.

Etrolizumab was study in a group of about 120 patients with moderate to severe ulcerative colitis. This trial was a randomized, placebo controlled, double-blind study with three treatment options. The first treatment option was four infusions of the placebo. The second treatment option was 300mg of Etrolizumab at weeks 0, 4, and 8 and a placebo infusion at week 2. The third treatment option was a dose of 420mg of Etrolizumab at week 0 and 300mg of Etrolizumab at weeks 2, 4, and 8. The goal of the study was remission of ulcerative colitis at week 10. Remission is defined as a Mayo score of 2 or less. The Mayo score is a combination score based on number of bowel movements per day, how much rectal bleeding the patient is having, what the colitis looks like after endoscopy, and the physician's assessment of the colitis.

At the end of the study, none of the placebo treated patients were in remission, 21% of the patients in the lower dose of Etrolizumab were in remission, and 10% of the patients at the higher dose were in remission. The researchers also looked at serious adverse events. The rate of serious adverse events was 12% in the placebo treated patients, 12% in the lower dose of Etrolizumab patients, and even lower for the patients that received the higher dosage of Etrolizumab.

The results of the study show that the phase two trial was positive and the study will continue to phase three.

Read the full study online here.

For more information about IBD, visit mayoclinic.org/ibd.

Dr. Loftus is a gastroenterologist at Mayo Clinic.

Tags: Edward Loftus, Etrolizumab, FDA, IBD, The Lancet, ulcerative colitis

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