P0292 - Development and Validation of a Simple Eosinophilic Esophagitis Severity Score That Is Predictive of Key Disease Parameters After Treatment With Topical Steroids

Sunday, October 24, 2021

3:30 PM – 7:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Cary Cotton, MD, MPH

University of North Carolina School of Medicine
Chapel Hill, NC, United States

Cary Cotton, MD, MPH, Susan Moist, , Sarah McGee, , Nicholas Shaheen, MD, MPH, Evan S. Dellon, MD, MPH, FACG
University of North Carolina School of Medicine, Chapel Hill, NC

Introduction: Patients with eosinophilic esophagitis (EoE) can present with a wide spectrum of severity but validated measures of overall disease severity are lacking. An objective measure of overall disease severity is needed by clinicians to calibrate diagnostic and treatment decisions in the heterogeneous population of EoE patients. We sought to develop an overall severity score to characterize EoE at baseline, to assess its predictive ability for key disease parameters after treatment with topical steroids, and to validate it in an external population.

Methods: We performed post-hoc analyses of a randomized clinical trial comparing budesonide slurry to swallowed fluticasone multidose inhaler for treatment of EoE in adolescents and adults. We developed a simple score that gave participants one point each for: dysphagia symptom severity (defined as a score >3 on a 10-point Likert scale); peak eosinophil count ≥75 eos/hpf; peak eosinophil count ≥150 eos/hpf; dilation at baseline; EoE Reference Score (EREFS) >2; and EREFS >4. The total severity score ranged from 0-6. We assessed the odds ratio per point for prediction of post-treatment requirement for dilation. We assessed the linear association post-treatment peak eosinophil count, EREFS, and dysphagia Likert score. Finally, we validated the score for the same measures in an independent sample.

Results: We included 58 subjects from the clinical trial in development group and 76 subjects in the prospective cohort in the validation group. In the development dataset, the higher severity scores were associated with increasing baseline eosinophil counts (mean 36.7 to 148.4), baseline dilation (0% to 90%), and increasing baseline EREFS (2.3 to 5.8). Similar stratification was seen in the validation dataset (Table). In the development dataset, increasing severity score predicted the need for post-treatment dilation, post-treatment maximum eosinophil count per high-powered field, and post-treatment EREFS, and similar results for predication were seen in the validation cohort (Figure). Scores of 0 or 1 were mild, score of 2, 3, or 4 were moderate, and score of 5 or 6 were severe.

Discussion: We derived an overall severity score for EoE at diagnosis. The score tracked well with key measures of EoE severity at follow-up in both the learning and validation dataset. This simple EoE severity score could be used to summarize complex information about EoE for clinical reasoning and to define severity groups for research.

Figure: The Baseline Severity Score Tracks Well with Post-Treatment Measures of Disease Severity Including Requirement for Follow-up Dilation, Peak Eosinophil Count, Eosinophilic Esophagitis Endoscopic Reference Score, and Dysphagia Likert Score.

	Overall	Mild (score 0 or 1)	Moderate (score 2 to 4)	Severe (score 5 or 6)
Development dataset
N	58	3	45	10
Age - Mean (SD)	41.7 (14.2)	45.7 (18.1)	40.4 (13.4)	46.3 (16.9)
Female sex - N (%)	19 (32.8)	1 (33.3)	15 (33.3)	3 (30.0)
Non-Hispanic White - N (%)	56 (96.6)	3 (100.0)	43 (95.6)	10 (100.0)
Baseline dilation - N (%)	34 (58.6)	0 (0.0)	25 (55.6)	9 (90.0)
Baseline dysphagia Likert - Mean (SD)	4.5 (2.5)	1.7 (1.2)	4.7 (2.5)	4.7 (2.3)
Baseline eosinophil count - Mean (SD)	77.6 (52.4)	36.7 (20.2)	64.6 (40.6)	148.5 (47.3)
Baseline EREFS - Mean (SD)	4.8 (1.5)	2.3 (0.6)	4.7 (1.5)	5.8 (0.6)
Any eosinophil microabscess - N (%)	47 (81.0)	2 (66.7)	35 (77.8)	10 (100.0)
Any eosinophilic degranulation - N (%)	41 (70.7)	2 (66.7)	32 (71.1)	7 (70.0)
Validation dataset
N	76	16	44	16
Age - Mean (SD)	39.0 (13.4)	38.3 (11.2)	39.4 (13.4)	38.7 (16.0)
Female sex - N (%)	33 (43.4)	5 (31.2)	21 (47.7)	7 (43.8)
Non-Hispanic White - N (%)	72 (94.7)	15 (93.8)	43 (97.7)	14 (87.5)
Baseline dilation - N (%)	24 (31.6)	0 (0.0)	13 (29.5)	11 (68.8)
Baseline dysphagia Likert - Mean (SD)	4.0 (3.0)	2.8 (3.0)	3.6 (3.1)	6.1 (1.8)
Baseline eosinophil count - Mean (SD)	125.2 (111.6)	49.0 (35.3)	130.7 (122.9)	186.2 (86.2)
Baseline EREFS - Mean (SD)	3.9 (2.2)	1.8 (0.8)	3.8 (1.9)	6.3 (1.4)
Any eosinophil microabscess - N (%)	47 (75.8)	4 (36.4)	29 (78.4)	14 (100.0)
Any eosinophilic degranulation - N (%)	60 (95.2)	9 (75.0)	37 (100.0)	14 (100.0)
N, number, SD, standard deviation, EREFS, eosinophilic esophagitis endoscopic reference score.

Table: Baseline Clinical, Endoscopic, and Histologic Characteristics Overall and Among Proposed Subgroups of the Overall Severity Score in the Development and Validation Datasets Show Excellent Baseline Stratification by the Severity Score.

Disclosures:
Cary Cotton indicated no relevant financial relationships.
Susan Moist indicated no relevant financial relationships.
Sarah McGee indicated no relevant financial relationships.
Nicholas Shaheen indicated no relevant financial relationships.
Evan Dellon indicated no relevant financial relationships.

Cary Cotton, MD, MPH, Susan Moist, , Sarah McGee, , Nicholas Shaheen, MD, MPH, Evan S. Dellon, MD, MPH, FACG. P0292 - Development and Validation of a Simple Eosinophilic Esophagitis Severity Score That Is Predictive of Key Disease Parameters After Treatment With Topical Steroids, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.