S1398 Should IVIG Be Used Alone or With Other Gastroparesis Therapies?

Abstract

Introduction: Intravenous Immunoglobulin (IVIG) has been shown to be helpful for some patients with gastroparesis, many of whom have neuromuscular markers, that are refractory to available drugs, devices, and surgical therapies. We evaluated the effectiveness of IVIG therapy by itself compared with IVIG and Gastric Electrical Stimulation (GES) and/or pyloric therapy. Methods: We studied 112 patients with diagnosis of gastroparesis and gastroparesis-like syndrome (GLS) that had all failed previous therapies including available and investigational drugs, devices and/or pyloric therapies. Seventy-one patients had full thickness GI biopsies. Patients received standardized 12-week courses of IVIG, dosed as 400mg/kg per week IV. Symptom assessment was done with FDA compliant traditional patient reported outcomes including both upper and lower GI symptoms. Patients were categorized in a non-randomized fashion into three sub-groups: IVIG only; IVIG and GES; IVIG, GES with pyloric therapy. Success to IVIG was defined as 20% or greater reduction in average symptom scores from baseline to post-IVIG evaluation. Descriptive analysis was performed. Results: Overall, 28.6% of patients responded to IVIG therapy with or without other therapies. In these patients, the average duration of therapy was 39 weeks. IVIG solo therapy had higher response rates compared to IVIG along with GES and pyloric therapies (36.4% vs. 27.9% and 24.1%). IVIG combined with other therapies such as GES and pyloric therapy reduced the total duration of IVIG required (47.0 vs. 40.0 and 36.1 weeks). Conclusion: In this moderately-sized open label series of patients with gastroparesis symptoms treated with IVIG conjunction with other therapies for gastroparesis, 28.6% of patients responded. Use of other therapies for gastroparesis such as GES and pyloric therapies along with IVIG help reduce the duration of IVIG infusions. We conclude that a clinical trial of IVIG may be warranted in severely refractory patients with gastroparesis symptoms.Table 1.: Comparison of IVIG Response Amongst Various Sub-Groups.