# STABILITY' (symptomatic review during biologic therapy) Review in Inflammatory Bowel Disease

> **NIH NIH P20** · LOUISIANA STATE UNIV A&M COL BATON ROUGE · 2021 · $292,026

## Abstract

PROJECT SUMMARY
This proposal responds to the NOSI funding opportunity announcement for women’s complementary/alternative
health approaches in IDeA states to more effectively manage women’s health. Immune-mediated diseases
typically show a female preponderance and looking at all autoimmune diseases combined, 8 of 10 patients are
females. Although not as prominent, gender differences in inflammatory bowel disease (IBD) have been reported
for epidemiology, disease presentation, disease course and complications, medical and surgical therapies,
adherence, psychosocial functioning, and psychiatric co-disorders (Greuter et al., 2020). IBD (including Crohn’s
disease (CD) and ulcerative colitis (UC)) has significant and progressive health issues affecting women.
The Department of Gastroenterology and Internal Medicine subdivision of LSU Health Sciences Center in
Shreveport serves a predominantly minority-based urban population with a large rural catchment area. Our IBD
patients historically received their infusions of biologic therapy (Remicade, Cimizia) as a ‘nurse only visit’ at our
infusion center. However, starting March 2019, we started having one of the GI fellows and faculty see all IBD
patients during these infusion visits. These brief visits included an interview with the patient about his/her current
symptoms, review of their labs and drug levels and assessed if there was need to complete any care gaps
(endoscopy, abdominal imaging, vaccinations, etc.). These ‘STABILITY’ (symptomatic review during biologic
therapy) visits took ~15 minutes. Based on our first preliminary study of symptomatic review during biologic
infusion therapy (STABILITY) in IBD patients in this service area for the period of March 2019 to March 2020
this approach improves disease control at earlier phases and maintains patient clinical progress at reduced cost
and with fewer hospitalizations. Surveyed patients expressed unanimous enthusiasm for continued STABILITY
review with their doctors during infusion visits
Hypothesis. Based on these preliminary findings, it is our hypothesis that very modest changes in disease review
in female patients with IBD can dramatically improve their outcomes and reduce hospitalizations.
Aim 1. Determine in which female patients (African-American vs. white, age group, socioeconomic status,
insurance status, etc.) does ‘STABILITY’ review improve patient outcomes, their quality of life while at the same
time reducing overall costs of care.
Aim 2. Which clinical features of IBD (such as disease severity, CRP, calprotectin, sedimentation rate and other
inflammatory biomarkers) are best improved by ‘STABILITY’ review.
Aim 3. Incorporate the results of our study into the clinical decision support system providing individualized
symptom management recommendations to clinicians at the point of care to improve outcomes of female IBD
patients.

## Key facts

- **NIH application ID:** 10393268
- **Project number:** 3P20GM103424-20S2
- **Recipient organization:** LOUISIANA STATE UNIV A&M COL BATON ROUGE
- **Principal Investigator:** Konstantin G Kousoulas
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $292,026
- **Award type:** 3
- **Project period:** 2001-09-25 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10393268

## Citation

> US National Institutes of Health, RePORTER application 10393268, STABILITY' (symptomatic review during biologic therapy) Review in Inflammatory Bowel Disease (3P20GM103424-20S2). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10393268. Licensed CC0.

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