P048 SHORT- AND LONG-TERM OUTCOME OF PATIENTS TREATED WITH INDIGO NATURALIS FOR INFLAMMATORY BOWEL DISEASE: A SINGLE CENTER RETROSPECTIVE STUDY

Abstract

Indigo naturalis (IN) is a traditional Chinese herbal medicine reported to be effective for inducing remission in ulcerative colitis (UC). We conducted a retrospective observational study to investigate the efficacy and safety of IN for inducing and maintaining remission in patients with inflammatory bowel disease (IBD). Data were collected from electric medical records of IBD patients who had been started IN between March 2015 and April 2017 at Kyushu University hospital. Cumulative IN continuing rates at 8, 52, and 104 weeks were estimated using the Kaplan-Meier method. Among patients who could sustain IN treatment, clinical remission (clinical activity index (CAI) ≤4, Crohn’s disease (CD) activity index (CDAI) ≤150) rate at each point was also assessed. In addition, overall adverse events (AEs) during the treatment of IN were analyzed. Seventeen UC patients and eight CD patients were enrolled. The median CAI score in UC was 8 (range; 5-13), and the median CDAI in CD was 227 (range; 158-291). The cumulative IN continuing rates at 8, 52, and 104 weeks were 88%, 76%, and 71% in UC patients, and 75%, 38%, and 38% in CD patients, respectively. Among patients who could sustain IN treatment, clinical remission rates at 8, 52 and 104 weeks were 94%, 100%, and 100% in UC patients and 33%, 67%, and 67% in CD patients, respectively. A total of 10 patients (40%) experienced AEs during follow-up. Mild AEs including headache, liver dysfunction and renal dysfunction were observed in 9 patients. However, serious AEs were identified in three patients; one patient developed ileocecal intussusception requiring surgery and two patients developed acute colitis requiring hospitalization. IN showed good short- and long-term therapeutic efficacy for UC, however, therapeutic efficacy for CD seemed to be modest. While not so common, possible risk of serious adverse events should be kept in mind when using IN.