Solving the questions regarding 5-aminosalitylate formulation in the treatment of ulcerative colitis

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Solving the questions regarding 5-aminosalitylate formulation in the treatment of ulcerative colitis Makoto Naganuma1

Received: 17 June 2020 / Accepted: 22 July 2020 Ó The Author(s) 2020

Abstract 5-aminosalicylate is a fundamental treatment for patients with ulcerative colitis with mild-to-moderate disease; however, evidence for 5-aminosalicylate treatment is unclear in some situations. This review discusses the clinical guidelines and previous studies, and highlights the following points: (1) Although rectal 5-aminosalicylate is effective for proctitis, physicians should endeavor to reduce patient’s distress when administering suppositories or enema as the first-line therapy. It should be clarified whether oral 5-aminosalicylate alone with a drug delivery system that allows higher 5-aminosalicylate concentrations to reach the distal colon would be as effective as rectal 5-aminosalicylate therapy. (2) There has been no direct evidence demonstrating the clinical efficacy of switching the 5-aminosalicylate treatment to other 5-aminosalicylate formulations. However, switching to a different 5-aminosalicylate formulation may be indicated if clinical symptoms are not progressive. (3) Several studies have shown that colonic mucosal 5-aminosalicylate concentration correlates with clinical and endoscopic severity; however, it is unclear whether a high 5-aminosalicylate concentration has therapeutic efficacy. (4) The maximum dose of 5-aminosalicylate is necessary for patients with risk factors for recurrence or hospitalization. (5) Optimization of 5-aminosalicylate dosage may be indicated even for quiescent patients with ulcerative colitis if mucosal healing is not obtained, and if patients have multiple risk factors for

& Makoto Naganuma [email protected] 1

The Third Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University, 2-5-1, Shinmachi, Hirakata, Osaka 573-1010, Japan

recurrence. (6) Furthermore, the discontinuation of 5-aminosalicylate is acceptable when biologics are used. Because there are many ‘‘old studies’’ providing evidence for 5-aminosalicylate formulations, more clinical studies are needed to establish new evidence. Keywords Ulcerative colitis  5-aminosalicylates  Guideline  Proctitis  Biologics Abbreviations UC Ulcerative colitis 5-ASA 5-Aminosalicylate ACG American College of Gastroenterology BSG British Society of Gastroenterology ECCO The European Crohn’s and Colitis Organization SASP Sulfasalazine MMX Multimatrix CI Confidence interval

Introduction Ulcerative colitis (UC) is a chronic inflammatory bowel disease with relapsing and remitting abdominal symptoms, including rectal bleeding, diarrhea, and abdominal pain. Although the fundamental pathophysiology of UC has not been clearly described, a recent study has reported on the host genetic factors, immune system dysregulation, and environmental factors associated with UC [1]. At present, 5-aminosalicylates (5-ASAs) and corticosteroids are the first-line treatments for patients wi