P328. The use of IVIG in IBD patients with contraindications or who are unresponsive to conventional treatment for inflammatory bowel disease
S. Merkley1, S. Horst2, D. Beaulieu2, C. Duley2, K. Annis2, A. Nohl2, D. Schwartz2, 1University of Kentucky, Department of Medicine. Division of Gastroenterology, Hepatology, and Nutrition, Lexington, United States, 2Vanderbilt University, Department of Medicine. Division of Gastroenterology, Hepatology, and Nutrition, Nashville, United States
The management of patients (pts) with inflammatory bowel disease (IBD) that are refractory or have contraindications to current medical therapies can be challenging. Many pts with IBD will lose response, become intolerant to treatment, or develop a serious infection that will contraindicate use of immunosuppression. Effective alternative therapies, such as the use of intravenous immunoglobulin (IVIG), are needed to manage IBD in these cases.
Data was extracted retrospectively from a chart review of the electric medical records at Vanderbilt University on all pts with IBD who received IVIG over a 2-year period (Feb 10, 2011-June 1, 2013). Pts were treated with 0.4 g/kg/d x3 initially and then 0.4 g/kg once monthly. Those that had a partial response or lost response to initial treatment were increased to 0.4 g/kg every other week. Clinical response to IVIG was defined as a decrease in the Harvey–Bradshaw Index (HBI) score of >3 points and as an improvement in CRP by >25%. Clinical remission was defined as a HBI score <5 points, no hospitalizations or surgeries after starting IVIG, and/or continued resolution of symptoms. Statistical analysis was performed using Wilcoxon matched-pairs signed-rank test.
24 pts (23 Crohn's disease, one ulcerative colitis) received IVIG. 16 pts were female, with a median age of 41 (range 20, 69 years). 17 pts received IVIG for failure of standard treatment. 6 pts received IVIG as an alternative therapy during an active infection when immunosuppression was contraindicated. Two pts had histoplasmosis, one pt had tuberculosis, and two pts had pulmonary fungal infections. One pt with breast cancer was given IVIG for recurrent C.diff infection and active UC. 9 pts required dose escalation after induction at a median of 153 days (30, 360 days). 19 (79%) had response or remission to initial induction with IVIG. CRP decreased significantly after treatment [19 mg/dl (range 0.1, 77) to 7.5 (0.2, 20)], p < 0.05. HBI scores improved [8 (0, 19) to 6 (0, 17)], p = NS. 11 pts had pre- and post-treatment colonoscopies, and 8 pts had active Crohn's disease present prior to IVIG. Endoscopic improvement was seen in 7 pts (62.5%) after IVIG treatment. The most common reported side effect was headache in 5 pts. One pt developed a febrile illness after induction. 3 pts were hospitalized after starting IVIG; one pt was hospitalized for fever and two had surgical treatment of a fibrotic stricture present prior to starting IVIG.
Our results indicate that IVIG is a safe and effective agent in the short-term management of pts with refractory disease or in whom biologics are contraindicated. However, larger studies are needed to verify these results.