The Growing Role of Biologics in Gastroenterology

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Four gastroenterologists share their thoughts on the most exciting opportunities for biologics in the GI field.

Ask a Gastroenterologist is a weekly series of questions posed to GI physicians around the country on business and clinical issues affecting the field of gastroenterology. We invite all gastroenterologists to submit responses. Next week's question: How can gastroenterologists improve communication with their patients?

Please submit responses to Carrie Pallardy at by Thursday, April 24, at 5 p.m. CST.

Dr. James LeeJames Lee MD, AGAF, St. Joseph Hospital, Orange, Calif.: Biologics refer to synthetic peptides that targets specific mediators of inflammation in a specific disease. These mediators of inflammation are either over-active or inappropriate resulting in tissue damage. Some of the conditions that can be treated with biologics in gastroenterology include inflammatory bowel disease such as Crohn's and ulcerative colitis, eosinophilic esophagitis and Clostridium difficile colitis.

There are now five biologics approved for the treatment of inflammatory bowel disease: Remicade, Humira, Cimzia, Simponi and Tysabri. The first four agents work against tumor necrosis factor-alpha and Tysabri works by inhibiting certain immune cells, integrin, from binding to other cells in the intestinal lining.

EoE is an allergic manifestation of the esophageal lining to certain foods resulting in the formation of stricture. Patients can present with food bolus impaction in the esophagus. Mepolizumab and Reslizumab are monoclonal antibody against interleukin 5, which triggers eosinophil proliferation and activation. In recent trials they have been effective in improving symptoms of EoE.

Another area of the use of biologics is the prevention of Clostridium difficile colitis. C. diff is brought on by destruction of natural gut flora by systemic antibiotics. Using an oral biologic targeted for beta lactam contained in all penicillin derived antibiotics and cephalosporin, gut micro flora can be preserved and C. diff prevented. This is an ongoing area of research. These are few of the examples of the use of biologics in the field of gastroenterology.

Marc Wishingrad, MD, Providence Saint John's Health Center, Santa Monica, Calif.: Over the past 15 years, biologics have revolutionized how we approach inflammatory bowel disease. Instead of simply trying to control patients' symptoms, we are now striving for complete mucosal healing and "deep remission," concepts that didn't exist before the era of biologics. The goal is to change the natural history of the disease by identifying patients at risk for complications and jumping in early with aggressive therapy.

The anti-TNF agents (infliximab, adalimumab, golimumab and certolizumab) are now joined by agents that affect other parts of the inflammatory cascade—integrins (natalizumab and vedolizumab), interleukin 12/23 (ustekinumab), JAK3 (tofacitinib) and others.

So far, biologics have been used by gastroenterologists primarily in IBD.  But other immune gastrointestinal diseases — celiac disease, eosinophilic esophagitis, eosinophilic gastroenteritis, autoimmune enteropathy and autoimmune hepatitis — are also fertile areas for their use.  Currently, only patients with refractory disease would be candidates for biologics in this setting.  But as newer agents become available — with better risk/benefit ratios — that may change.
Finally, the most "natural" of biologic therapies are currently being studied: worms and fecal transplant.

Patrick Takahashi, MD, CMIO and Chief of Gastroenterology Section of St. Vincent Medical Center, Los Angeles: Traditional biologics have played an imperative role in Patrick Takahashigastroenterology, namely with inflammatory bowel disease.  By targeting chemical messengers involved in intestinal inflammation, they have played a major role in decreasing steroid dependence in inflammatory bowel disease.  They have also helped to obviate the need for surgery in a large proportion of patients with IBD.

An increasing role of biologics has been in the area of irritable bowel syndrome. In the future, it is thought that by decreasing the role of methane producing bacteria, constipation predominant irritable bowel syndrome patients can have greater relief of symptoms. In addition, future biologic endeavors revolve around protecting the gut microflora from antibiotic therapy so that such pathogens as Clostridium difficile cannot obtain a foothold within the gut as easily.

Dr. Zelner Richard Zelner, MD, Orange Coast Memorial Medical Center, Fountain Valley, Calif.: Biologic agents represent a broad group of agents used in medicine. Among these include vaccines, hormonal therapies, blood products, human cells used for transplant, gene therapies and cellular therapies. Currently, gastroenterologists are effectively using anti-tumor necrosis agents to treat Crohn's and inflammatory bowel disease.

Gene therapies, in which the behavior of an aberrant gene that may cause cancer or a disease process is modified, are the subject of a great deal of research. This holds great promise for the future. Stem cell research in which the possibility of a biologically identical organ can be created to replace a diseased organ is also the subject of great deal of research and holds great promise for the future.

More Articles on Gastroenterology:
What Role Will Cologuard Play in the GI Field? Q&A With Dr. Steven Itzkowitz
Boosting GI Patient Volume: Keeping Up With Technology, Improving Patient Experience & More
Physician Compensation by Specialty: Where Does Gastroenterology Rank?

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