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Opens New Doors for GI Patients By Douglas Wolf, M.D. Today, there are approximately 1.2 million patients in the United States with Crohn’s disease and ulcerative colitis (UC). Although the cause of these conditions is unknown and currently there is no cure, there are many effective medical treatments, and interest in clinical research in both ulcerative colitis and Crohn’s disease is increasing rapidly. Over the last decade, the physicians at Atlanta Gastroenterology Associates (AGA) have played a key role in many clinical trials and the practice is considered one of the top 10 centers in the country offering treatment options for patients with Crohn’s disease and UC. As a result of some successful study outcomes, AGA patients are reaping the benefits. For one 33-year-old patient in particular, the clinical trials have resulted in a better quality of life. “Joe’s” Story As a young man with a wife and 15-month-old baby, “Joe” faced several challenges. Suffering from a type of Crohn’s disease that affected his entire colon, surgery to remove the colon was an option, but not a very good one. Having been on Prednisone, an oral corticosteroid, for seven years, he had developed facial edema, body swelling and fluid retention. He even developed osteoporosis. Over time, we tried several different medications, but he no longer responded to the drugs and continued to suffer from edema and osteoporosis. When a new drug, Tysabri (generically known as natalizumab), became available last January, we switched “Joe” to the new medication. 12 An InsideLook Dr. Douglas Wolf reviews clinical trial documentation with his research coordinator, Katie Neri, RN. For the first time in seven years, he was able to stop taking Prednisone and stay off of it. His swelling started to diminish and today he is feeling better than he has in a long time. The clinical trial resulting in “Joe’s” remarkable turnaround is just one of 30 studies in which I have acted as principal investigator over the last decade. Others include trials for infliximab (also known as Remicade®), used both to induce remission and maintenance of active Crohn’s disease and to treat fistulizing Crohn’s disease, as well as adalimumab (Humira®), and certolizumab (Cimzia®), which are used to treat patients with active Crohn’s disease and patients who have lost response or had infusion reactions to Remicade. These drugs are known as biologics, i.e., injectable treatments created from human or animal proteins. First approved for use in treating Crohn’s disease in 1998, they are given by intravenous infusion over one to two hours or by injection. Patients often notice an improvement in symptoms within weeks and sometimes days of their treatment. Despite the impressive success in some cases, no drug keeps patients in remission more than 30 percent of the time. In fact, some patients can develop antibodies against a drug after repeat treatments, decreasing the drug’s effectiveness. As a result, other medications are recommended to help ease their symptoms. Finding the most effective treatments for these debilitating diseases is at the core of our clinical trial efforts, and makes research a vitally important part of our practice. About Clinical Trials All clinical trials at Atlanta Gastroenterology are conducted through our research division, the Center for Clinical Research, and every study is FDA-approved and monitored by the regulatory divisions of the pharmaceutical industry. In addition, the research center is supervised by board certified gastroenterologists and has a full-time staff of trained and certified clinical research coordinators. The majority of the clinical trials offered are Phase II and Phase III trials, which test the safety and efficacy of new drugs being developed for the treatment of both Crohn’s disease and ulcerative colitis. By providing a broad range of treatment options through clinical trials, patients have a real advantage, particularly those having difficulties with current medications. Because patients can lose responsiveness to drugs used to treat Crohn’s disease, for example, participating in a clinical trial may give them the opportunity to benefit from new medications two to five years before they are released by the FDA. Offering our patients the opportunity to try investigational drugs not only increases their chances of gaining a better quality of life, but those patients also make an important contribution to research efforts for Crohn’s disease and ulcerative colitis. Those research efforts are constantly expanding. As a physician, participating in clinical trials is extremely gratifying. Being involved in cutting edge research of biologic therapy for Crohn’s disease is just one promising aspect. In addition, AGA is currently enrolling patients in clinical trials to study the use of stem cell therapy and Chinese herbs to treat Crohn’s disease. No other practice in the Atlanta area – or the southeast – is involved in gastrointestinal clinical trials quite like these. While many patients may be discouraged after trying medications that have not worked, it is through these clinical trials that new options and a better understanding of currently available drugs are being discovered. With new therapeutic options on the horizon every day, the future is bright for patients with ulcerative colitis and Crohn’s disease. For more information on participating in clinical trials or treatment options for Crohn’s disease, make an appointment with Dr. Wolf or contact Study Coordinator Katie Neri, RN, at 678-538-1584. Douglas C. Wolf, M.D. Board Certified Internal Medicine and Gastroenterology Dr. Wolf is a graduate of Duke University in Durham, North Carolina. He completed medical school, as well as his internship and residency, at the West Virginia School of Medicine in Morgantown. Following completion of a fellowship in gastroenterology at the Cleveland Clinic in Ohio, Dr. Wolf joined the faculty at Emory University Hospital in Atlanta as senior associate of medicine in digestive diseases and was later named assistant professor of medicine for digestive diseases. He presently serves on the visiting faculty at the Annenberg Medical Center. Dr. Wolf is an active member of many professional organizations and holds several leadership and committee appointments. He is a member of the American Gasroenterologic Association, the American College of Physicians, the American Society for Gastrointestinal Endoscopy, the American College of Gastroenterology, the Georgia Gastroenterologic and Endoscopic Society, the American Federation for Clinical Research, and the American Medical Association. He is past president of the Atlanta Gastroenterology Club and also serves on the Board of Trustees for the Georgia Crohn’s and Colitis Foundation. Dr. Wolf joined Atlanta Gastroenterology Associates in 1994 and sees patients at the Saint Joseph’s location. www.atlantagastro.com 13