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Blood tests for colitis and Crohn’s disease are a relatively new and exciting development that have added significantly to the screening, diagnosis and management of ulcerative colitis and Crohn’s disease. Differentiating the two may allow better predictions regarding responses to medical treatments, decisions regarding surgery options and the risks of various complications. Antibodies to variou

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

s proteins including Baker’s or Brewer’s yeast (saccharomyces cerevisiae) and bacteria like Escherichia. coli (E. coli) are present in the blood of many people with Crohn’s disease but rarely in normal people. Antibodies to a normal cell component, a nuclear protein, is present in most people with ulcerative colitis, a few people with Crohn’s whose colitis behaves more like ulcerative colitis th

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

an Crohn’s, and rarely in normal people.

Antibody tests or serologic markers are blood tests looking for markers of diseases. The serologic markers or antibody tests for ulcerative colitis and Crohn’s disease are pANCA and ASCA, OmpC, and CBir1 Flagelin respectively. The latter three blood tests for Crohn’s are only available through one laboratory, Prometheus Laboratories, Inc.

Ulcerative col

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tis is a chronic inflammatory bowel disease (IBD) of unknown cause that only involves the colon. It affects the superficial lining of the colon and rarely causes bowel obstruction (blockage) or perforation (rupture) but frequently causes severe bloody diarrhea, blood in the stool, weight loss, abdominal pain, as well as joint aches or arthritis, skin rashes, eye irritation and occasionally a sev

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ere liver disorder known as primary sclerosing cholangitis that can lead to cirrhosis and liver cancer. Ulcerative colitis can be cured by complete removal of the colon but not Crohn's disease.

Crohn’s disease can also cause colitis but usually also affects the very end of the small intestine called the ileum (ileitis or regional enteritis). When Crohn’s affects only the colon it may be difficu

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

t to distinguish it from ulcerative colitis though Crohn’s tends to affect the colon in a patchy manner whereas ulcerative colitis is continuous. Crohn’s can affect the gastrointestinal tract anywhere from the mouth to the anus and is not curable by removing the colon. It is also frequently associated with bowel strictures (constrictions) causing obstruction that may require surgery. It also may

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

be associated with fistula that are abnormal connections of the intestine to other organs and the skin or it can result in abscesses or perforation requiring surgery It is important to distinguish Crohn’s disease from ulcerative colitis since medical treatments and surgical approaches may differ and the types of complications that can occur can be much different.

Traditionally, the diagnosis o

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ulcerative colitis and Crohn’s disease is highly accurate by the appearance of the colon on colonoscopy or x-rays that confirm the presence or absence of involvement of other parts of the intestinal tract. Diagnosis is confirmed by a typical pattern of inflammation of the intestine lining as seen under the microscope on tissue obtained by biopsy during colonoscopy. However, before blood tests w

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ere available about 10% of people with IBD were diagnosed as having an indeterminate colitis because the biopsies could not distinguish between the ulcerative colitis and Crohn’s disease.

The blood tests currently available are pANCA, anti-ASCA, anti-OmpC, and anti-CBir1 flagelin antibodies. pANCA is the peripheral anti-nuclear antibody. It is an abnormal antibody to nuclear protein of cells an

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

is highly sensitive and specific for ulcerative colitis. The pANCA anbibody has been further divided into subsets by Prometheus Laboratories Inc. Neutrophil-specific pANCA ELISA (NSNA) is positive in the majority of people with ulcerative colitis (UC) and a small subset of people with Crohn’s disease that have disease characteristics more like UC. Immunofluorescent cellular staining of neutroph

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ils (NSNA IFA) and enzyme Dnase testing (NSNA DNase sensitivity) is also done as part of the Prometheus IBD Serology 7. The latter test when present in high levels is significantly associated with development of inflammation of the rectal pouch (pouchitis) created when someone has their entire colon removed for ulcerative colitis that does not respond to medical treatment.

ASCA is anti-sacchar

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

omyces cerevisiae antibody. Saccharomyces cerevisiae is Brewer’s or Baker’s yeast. Crohn’s patients have a high prevalence of abnormal antibodies to this yeast. Some have suggested that another yeast, Candida albicans, somehow plays a role in this abnormal response. A few people with celiac disease have this antibody present in their blood in the absence of signs of Crohn’s disease. OmpC is th

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

abbreviation for an antibody that develops in many Crohn’s patients to the outer membrane porin protein of the bacteria E. coli though that bacteria is not thought to be the cause of Crohn’s disease. Just recently Prometheus Laboratories added antibody testing for a specific protein on bacteria that constitutes the flagelin or hair like structure on certain bacteria enabling movement and attach

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ment of bacteria in the intestine called CBir1 flagelin.

Future blood tests may include antibodies against certain sugar (mannose) residues in the cell wall of the yeast saccharomyces cerevisiae. Anti-laminaribioside and anti-chitobioside antibodies were recently reported to be present in Crohn’s patients who were anti-ASCA negative possibly further strengthening the ability to distinguish them

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

from people with ulcerative colitis. This is also interesting because of suspicions and the lay public interest in the role of sugars or glycans and yeast in IBD. In particular the reports in lay literature of success of carbohydrate specific diet in IBD.

If you have a diagnosis of ulcerative colitis or Crohn’s disease these blood tests may be very helpful in your treatment. If you have unexpla

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ined abdominal pain, diarrhea, or blood in your stools then these tests should be considered. If you have a diagnosis of irritable bowel syndrome, these tests may exclude ulcerative colitis and Crohn’s disease. Since as many as 10% of people with ulcerative colitis and Crohn’s disease may also have celiac disease, celiac blood tests should also be considered. Lactose intolerance is also common i

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

IBD, IBS and celiac disease.

Future helpful information on colitis, Crohn’s disease, celiac disease, food allergies, food intolerance, food sensitivity, eosinophilic esophagitis and irritable bowel syndrome will be available from Dr. Scot Lewey, the food allergy expert-the food doc at www.thefooddoc.com. Information on colitis and Crohn’s disease can also be obtained from the Crohn’s and Colit

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

is Foundation of America (CCFA, www.ccfa.org). Dr. Scot Lewey is a member of the medical advisory panel for the Rocky Mountain Chapter of CCFA. For more information about Prometheus Laboratories Inc. see www.prometheuslabs.com. A more detailed explanation of the blood tests can be found in a separate article by the food doc and references below.

Abreu MT et.al. Use of Serologic Tests in Crohn’s

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

Disease. Clinical Gastroenterology and Hepatology. Vol.4, No. 3. 2001

Dotan I et.al. Antibodies Against Laminaribioside and Chitiobioside Are Novel Serologic Markers in Crohn’s Disease. Gastroenterology. Vol.131, No. 2. 2006

Mei, L et.al. Familial Expression of Anti-Escherichia coli Outer Membrane Porin C in Relatives of Patients with Crohn’s Disease. Gastroenterology. Vol. 130, No. 4 2006

St

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

adaert-Vitse et.al. Candida albicans Is an Immunogen for Anti-Saccharomyces cerevisiae Antibody Markers of Crohn’s Disease. Gastroenterology. Vol 130, No. 6. 2006

Targan, SR et.al. Antibodies to Cbir1 Flagelin Define a Unique Response That Is Associated Independently Crohn’s Disease. Gastroenterology. Vol.128, No.7. 2005

Copyright The Food Doc, LLC, 2006. All Rights Reserved. www.thefooddoc.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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