CASE SERIES REPORT ON THE MANAGEMENT OF IBD PATIENTS WITH ORAL IMMUNOGLOBULINS

Entera Health, Inc. Announces the Publication of a Case Series Report on the Use of Orally Administered Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in the Clinical Management of Patients with Inflammatory Bowel Disease (IBD).

Entera Health, Inc. announced today the publication of a clinical case series report in the Journal of Therapeutic Advances in Gastroenterology that summarizes a retrospective evaluation of 45 patients with either ulcerative colitis (UC) or Crohn’s disease (CD) who had EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) incorporated into their therapeutic regimens after failing to respond adequately to conventional therapies. An improvement in clinical symptoms was reported by 49% of IBD patients after just one week of SBI therapy, which increased to 76% of patients reporting symptom improvement after 12 weeks of SBI therapy. The odds ratio from a regression model demonstrated that IBD patients were 2.8 times more likely to report clinical improvement in symptom scores with the addition of SBI to their therapeutic regimens [95% confidence interval (CI) 1.266–6.016, p = 0.011]. Disease management was not significantly associated with age, gender, race or disease state and no side effects were reported.

The study was performed as a single center, retrospective chart review of IBD patients [CD, n = 38; UC, n = 7] who experienced limited to no response to traditional pharmaceutical therapies in controlling symptoms and subsequently received SBI (5 g/day) for nutritional support. Patients were contacted at least monthly to assess their response to SBI on symptom management as measured by a Likert scale (0 = none; 1 = minimal; 2 = moderate; 3 = significant; 4 = complete). The overall group response and percent improvement to SBI was determined over 12 weeks. Authors include: Ira Shafran, MD (Winter Park, FL), Patricia Burgunder, ARNP (Winter Park, FL), David Wei, PhD (Cary, NC), Hayley Young, PhD (Cary, NC), Gerald Klein, MD (Cary, NC), and Bruce Burnett, PhD (Cary, NC).

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About Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition resulting from an immune dysregulation of the intestinal tract, the cause of which remains to be determined [1]. In the US alone, it is estimated that IBD affects more than 1.6 million individuals [2]. The immune dysregulation that occurs in patients with IBD results in two distinct disease states: ulcerative colitis (UC) and Crohn’s disease (CD). Ulcerative colitis is a disease of unknown etiology that produces chronic inflammation of the colon, whereas CD is relapsing inflammatory condition affecting any part of the gastrointestinal tract. Patients with UC often present with symptoms of bloody loose stools, abdominal cramps, and fatigue [3], while patients with CD frequently present with symptoms of abdominal pain, fever, and clinical signs of bowel obstruction or bloody loose stools or mucus [4]. Evidence suggests that many factors that contribute to IBD, which partly explains why current treatment methods target the clinical symptoms associated with the inflammatory and immune response in an effort to avoid the need for surgery and address complications associated with IBD [1]. Since there is no cure for IBD, current treatment goals recommended by the Crohn’s and Colitis Foundation of America are to induce remission, maintain remission by preventing flare-ups, and improve overall quality of life.

About EnteraGam®

EnteraGam® is a prescription medical food product intended to provide for distinctive nutritional requirements that are unique for the clinical dietary management of specific intestinal disorders [e.g., in irritable bowel syndrome with diarrhea (IBS-D), inflammatory bowel disease (IBD), and HIV associated enteropathy]. EnteraGam® is required to be used under physician supervision as part of ongoing medical care for a specific condition or disease. EnteraGam® is also indicated for the clinical dietary management of enteropathy in patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients. For full prescribing information, please visit our product website at http://www.enteragam.com/.

Important Safety Information

EnteraGam® is a specially formulated protein source for the management of intestinal disorders. The product has been extremely well tolerated for up to a year in HIV patients and up to 8 months in infants. The major side effects in clinical trials (2-5%) have included mild nausea, constipation, stomach cramps, headache, and increased urination. EnteraGam® is contraindicated for patients with a hypersensitivity (allergy) to beef, or any components in EnteraGam®. Therefore, patients who have an allergy to beef or any component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant and nursing mothers. The choice to administer EnteraGam® in pregnant or nursing mothers is at the clinical discretion of the physician. Medical foods like EnteraGam® are required by FDA regulations to be dosed and monitored by physicians as part of ongoing care for patients with chronic conditions or diseases.

About Entera Health, Inc.

Entera Health, Inc. is focused on improving worldwide health through the development of clinically safe biotherapeutics to address unmet needs. Our passion is to help people thrive through healthier living. Our motivation for conducting basic research, clinical studies, and appropriately educating patients and healthcare providers is driven to meet this goal. Visit us at http://www.enterahealth.com/.

For questions, please contact:
Tom Heck, Chief Operating Officer
515-963-7560
Tom.Heck@enterahealth.com

Citations

Levesque, B.G., et al. (2015) Converging goals of treatment of inflammatory bowel disease from clinical trials and practice. Gastroenterology 148: 37-51.
Baumgart, D.C., and W.J. Sandborn. (2012) Crohn's disease. Lancet 380: 1590-1605
Crohn’s and Colitis Foundation of America. (2014) The facts about inflammatory bowel disease 1-20.
Danese, S, and C. Fiocchi. (2011) Ulcerative colitis. N Engl J Med 365: 1713-1725.


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