S0810 Dual Biologic Therapy for the Treatment of Severe/Refractory Inflammatory Bowel Disease: Intravenous Immunoglobulin in Combination With Standard Biologic Agents

Abstract

INTRODUCTION: Despite improved therapeutic options, a subgroup of Inflammatory Bowel Disease (IBD) patients follow a severe/refractory disease trajectory. Intravenous immunoglobulin (IVIG) is a biologic agent, derived from pooled human plasma, used to treat severe inflammation (i.e. vasculitis, dermatomyositis, etc.) which has been explored as a potential therapy for refractory IBD. However, the use of dual biologic therapy, with IVIG and a second standard biologic agent for IBD treatment has not been described. We report our institutional experience with dual biologic therapy; IVIG treatment with standard biologic therapy in refractory IBD. METHODS: We analyzed a prospective registry of consented IBD patients followed at a tertiary-center to identify Crohn’s disease (CD) or Ulcerative Colitis (UC) patients that received IVIG therapy for refractory disease. Patients that received IVIG for other conditions were excluded. Clinic visits, endoscopic reports and medication exposure before and after IVIG were collected. Harvey-Bradshaw index (HBI) for CD and Ulcerative Colitis Activity Index (UCAI) for UC were utilized to assess the disease course. Quality of life was characterized using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). RESULTS: Among 25 IBD patients (median age 43 yrs, median disease duration 14 yrs, CD 20, females 21), 14 received a combination of IVIG with a 2nd biologic agent (Table 1). Among 19 patients who had active disease before IVIG initiation, 6 (31.6%) achieved remission, 5 of them in combination with second biologic agent. The median improvement in HBI score was 2 (0–3) and in UCAI was 6 (2–10), while the median SIBDQ improvement was 2.5 (1–13). In 6 patients, CRP levels normalized. Furthermore, among 17 patients who were on systemic steroids before IVIG, 3 transitioned to topical steroids, 3 reduced the dosage and 2 patients completely tapered off steroids. In addition, 15 patients reported that IVIG therapy was helpful while 9 patients demonstrated marked improvement endoscopically. Finally, regarding side effects, 7 patients reported headache, 2 nausea, 1 emesis, 1 abdominal pain while 1 patient required hospitalization because of hives and shortness of breath after IVIG infusion. CONCLUSION: Dual biologic therapy using IVIG in combination with standard biologic agents is safe and effective in IBD patients with refractory disease. Further investigation is warranted to define the optimal use of IVIG alone or in combination with biologic agents in refractory IBD.Table 1Figure 1.: The effect of IVIG therapy in averages HBI and UCAI scores when used as monotherapy or in combination with another biologic agent.