PMID- 34974494 OWN - NLM STAT- MEDLINE DCOM- 20230106 LR - 20230223 IS - 1539-2031 (Electronic) IS - 0192-0790 (Linking) VI - 57 IP - 2 DP - 2023 Feb 1 TI - Baseline Characteristics and Predictive Factors of Intravenous Immunoglobulin Response in Drug and Device Refractory Gastroparesis Symptoms. PG - 172-177 LID - 10.1097/MCG.0000000000001655 [doi] AB - INTRODUCTION: Intravenous immunoglobulin (IVIG) has been shown in a small pilot series to be helpful for some patients with gastroparesis that is refractory to drugs, devices, and surgical therapies. Many but not all patients have serologic neuromuscular markers. We hypothesize that those patients with serologic markers and/or longer duration of therapy would have better responses to IVIG. MATERIALS AND METHODS: We studied 47 patients with a diagnosis of gastroparesis and gastroparesis-like syndrome that had all failed previous therapies including available and investigational drugs, devices, and/or pyloric therapies. Patients had a standardized 12-week course of IVIG, dosed as 400 mg/kg per week intravenously. Symptom assessment was done with Food and Drug Administration (FDA) compliant traditional patient-reported outcomes. Success to IVIG was defined as 20% or greater reduction in average symptom scores from baseline to the latest evaluation. RESULTS: Fourteen patients (30%) had a response, and 33 (70%) had no response per our definition. Patients responding had a higher glutamic acid decarboxylase 65 positivity (64% vs. 30%, P =0.049, missing=3) and longer duration of therapy (>12 wk/continuous: 86% vs. 48%, P =0.09). CONCLUSIONS: In this moderately sized open-label series of refractory patients with gastroparesis symptoms treated with IVIG, 30% of patients responded. While serologic markers and extended therapies show a trend to greater response, neither was statistically significant, except for glutamic acid decarboxylase 65 which showed a higher positivity rate in responders. We conclude that a clinical trial of IVIG may be warranted in severely refractory patients with gastroparesis symptoms. CI - Copyright (c) 2021 Wolters Kluwer Health, Inc. All rights reserved. FAU - Gala, Khushboo AU - Gala K AD - Department of Internal Medicine. FAU - Stocker, Abigail AU - Stocker A AD - Division of Gastroenterology, Department of Medicine, Hepatology & Nutrition. FAU - Tu, Yixi AU - Tu Y AD - Division of Gastroenterology, Department of Medicine, Hepatology & Nutrition, St Louis University, St Louis, MO. FAU - Nguyen, Vincent AU - Nguyen V AD - Division of Gastroenterology, Department of Medicine, Hepatology & Nutrition. FAU - McElmurray, Lindsay AU - McElmurray L AD - University of Louisville Health, Louisville, KY. FAU - Cooper, Kelly AU - Cooper K AD - University of Louisville Health, Louisville, KY. FAU - Chhabra, Garvit AU - Chhabra G AD - Department of Internal Medicine. FAU - Mathur, Prateek AU - Mathur P AD - Department of Internal Medicine. FAU - Vedanarayanan, Vetta AU - Vedanarayanan V AD - Department of Neurology, Dell Medical School, The University of Texas, Austin, TX. FAU - Pinkston, Christina AU - Pinkston C AD - Department of Bioinformatics and Biostatistics, School of Public Health and Information Sciences, University of Louisville. FAU - Abell, Thomas L AU - Abell TL AD - Arthur M Schoen MD Chair in Gastroenterology, Research Director Jewish Hospital GI Motility Clinic, Division of Gastroenterology, Department of Medicine, Hepatology, & Nutrition, University of Louisville. LA - eng PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20230201 PL - United States TA - J Clin Gastroenterol JT - Journal of clinical gastroenterology JID - 7910017 RN - 0 (Immunoglobulins, Intravenous) RN - 0 (Pharmaceutical Preparations) RN - EC 4.1.1.15 (Glutamate Decarboxylase) SB - IM MH - Humans MH - *Gastroparesis/therapy MH - Immunoglobulins, Intravenous/therapeutic use MH - Pharmaceutical Preparations MH - Glutamate Decarboxylase/therapeutic use MH - Pylorus MH - Treatment Outcome EDAT- 2022/01/03 06:00 MHDA- 2023/01/07 06:00 CRDT- 2022/01/02 20:39 PHST- 2021/02/10 00:00 [received] PHST- 2021/11/12 00:00 [accepted] PHST- 2022/01/03 06:00 [pubmed] PHST- 2023/01/07 06:00 [medline] PHST- 2022/01/02 20:39 [entrez] AID - 00004836-202302000-00009 [pii] AID - 10.1097/MCG.0000000000001655 [doi] PST - epublish SO - J Clin Gastroenterol. 2023 Feb 1;57(2):172-177. doi: 10.1097/MCG.0000000000001655.