E0347 - Twenty Percent of Patients With Inflammatory Conditions of the Pouch Demonstrate a More Refractory Disease State Within Twelve Months of Enrollment in a Multicenter Prospective Registry

Tuesday, October 25, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Edward Barnes, MD, MPH

University of North Carolina at Chapel Hill
Chapel Hill, NC

Edward Barnes, MD, MPH¹, Parakkal Deepak, MBBS, MS², Poonam Beniwal-Patel, MD³, Laura Raffals, MD, MS⁴, Maia Kayal, MD, MS⁵, Marla C. Dubinsky, MD⁶, Shannon Chang, MD⁷, Peter D. Higgins, MD, PhD, MSc⁸, Yue Jiang, PhD⁹, Raymond Cross, MD¹⁰, Millie Long, MD, MPH, FACG¹¹, Hans Herfarth, MD, PhD¹
¹University of North Carolina at Chapel Hill, Chapel Hill, NC; ²Washington University in St. Louis, St. Louis, MO; ³Medical College of Wisconsin Affiliated Hospitals, Wauwatosa, WI; ⁴Mayo Clinic Rochester, Rochester, MN; ⁵Icahn School of Medicine at Mount Sinai, New York, NY; ⁶Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, NY; ⁷NYU Langone Health, New York, NY; ⁸University of Michigan, Ann Arbor, MI; ⁹Duke University, Durham, NC; ¹⁰University of Maryland Medical Center, Baltimore, MD; ¹¹UNC Chapel Hill, Chapel Hill, NC

Introduction: Up to 80% of patients will develop pouchitis after proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, and approximately 10% will develop Crohn’s disease (CD) of the pouch. We designed a geographically diverse, eight-center, prospective registry to study the disease course among patients with one of four inflammatory conditions of the pouch. The aim of this study was to evaluate patterns of changes in diagnosis during the first 12 months after enrollment.

Methods: We enrolled patients with a confirmed diagnosis of acute pouchitis, chronic antibiotic dependent pouchitis (CADP), chronic antibiotic refractory pouchitis (CARP), or CD of the pouch. Diagnoses were based on standardized criteria and we obtained detailed clinical and demographic data at the time of enrollment. Patients completed follow-up assessments at 3, 6, and 12 months after enrollment, with treating physicians confirming their respective diagnoses at each time point. Associations between clinical and demographic data at baseline and a switch in diagnosis to a more refractory disease state were analyzed using chi-square testing.

Results: We enrolled 318 patients (10% acute pouchitis, 27% CADP, 12% CARP, and 51% CD of the pouch). During the first 12 months after enrollment, 31 of the 157 patients (20%) without CD of the pouch at enrollment switched diagnosis to a more refractory disease state, with 20 of 31 (65%) patients ultimately being diagnosed with CD of the pouch. Among 7 patients with acute pouchitis who switched diagnoses, 5 were diagnosed with CADP, 1 with CARP, and 1 with CD of the pouch. Among 19 patients with CADP who switched diagnoses, 4 were diagnosed with CARP and 15 were diagnosed with CD of the pouch. Four patients with CARP had a change in diagnosis to CD of the pouch during the study period. Patients who experienced a change in diagnosis were significantly more likely to be current smokers when compared to patients with no change in diagnosis during the study period (23% vs. 5%, p=0.001, Table 1).

Discussion: In a prospective registry of 318 patients from eight centers in the United States, 20% of patients without CD of the pouch at enrollment experienced a change in diagnosis to a more refractory inflammatory condition of the pouch during the first 12 months after enrollment. Patients who were current smokers were more likely to change diagnoses, and may represent a high risk group for earlier intervention and targeted smoking cessation efforts after IPAA.

	Change in Diagnosis within 12 Months of Enrollment n=31		No Change in Diagnosis within 12 Months of Enrollment n=287		p-value
	median	IQR	median	IQR
Current Age	50	44-59	52	38-62	0.873
	n	%	n	%
Female Sex	12	39	129	45	0.636
Race					>0.999
White	29	94	263	92
Black	1	3	16	6
Other	1	3	8	3
Hispanic ethnicity	3	10	7	2	0.063
BMI					0.271
Normal	17	55	114	40
Overweight	7	23	99	34
Obese	7	23	71	25
Disease extent prior to surgery					0.447
Proctitis	2	6	19	7
Left-sided colitis	5	16	22	8
Extensive colitis	19	31	151	61
Unknown	4	13	52	18
Indication for surgery					>0.999
Medically-refractory colitis	29	94	256	89
Dysplasia/colorectal cancer	1	3	13	5
Medically refractory + dysplasia/colorectal cancer	0	0	8	3
Other	1	3	9	3
Number of stages in surgery					0.590
1	2	6	35	12
2	10	32	114	40
Modified 2	3	10	19	7
3	15	48	103	36
IPAA surgery performed at current medical center	20	65	181	63	>0.999
Primary Sclerosing Cholangitis	2	6	23	8	>0.999
Clostridiodes difficile infection prior to IPAA	4	13	42	15	>0.999
Smoker at the time of colectomy	2	6	15	5	0.678
Current smoker	7	23	13	5	0.001
NSAIDs in the prior two weeks	12	39	104	36	0.846

Table: Table 1. Comparison of Baseline Demographics and Clinical Characteristics of Patients with an Inflammatory Condition of the Pouch and a Change in Diagnosis to those with No Change in Diagnosis

Disclosures:

Edward Barnes: AbbVie, Inc. – Consultant. Gilead – Advisory Committee/Board Member. Lilly – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member. Target RWE – Consultant.

Parakkal Deepak indicated no relevant financial relationships.

Poonam Beniwal-Patel: Takeda – Speakers Bureau.

Laura Raffals: Janssen Pharmaceuticals – Advisor or Review Panel Member.

Maia Kayal indicated no relevant financial relationships.

Marla Dubinsky: AbbVie – Consultant. Arena Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Eli Lilly – Consultant. Galapagos – Consultant. Genetech – Consultant. Gilead Sciences – Consultant. Janssen Pharmaceuticals – Consultant. Pfizer Inc – Consultant. Prometheus Laboratories – Consultant. Takeda – Consultant. Trellus Health – Shareholder. UCB – Consultant.

Shannon Chang: Abbvie – Consultant. BMS – Consultant. Pfizer – Consultant.

Peter Higgins: AbbVie – Consultant. Amgen – Consultant. Eli Lilly – Consultant. Gastrointestinal Health Foundation – Consultant. Genentech – Consultant. Imedex – Consultant. JBR Pharma – Consultant. Lycera – Consultant. National Institutes of Health – Grant/Research Support. Pfizer – Consultant. Takeda – Consultant, Grant/Research Support. The Crohn’s & Colitis Foundation – Grant/Research Support. Vindico Medical Education – Consultant.

Yue Jiang indicated no relevant financial relationships.

Raymond Cross: Abbvie – Advisory Committee/Board Member, Consultant. BMS – Advisory Committee/Board Member. Fzata – Consultant. Janssen – Advisory Committee/Board Member, Grant/Research Support. Magellan Health – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Samsung bioepis – Consultant. Takeda – Advisory Committee/Board Member.

Millie Long: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Calibr – Consultant. Eli Lilly – Consultant. Genentech – Consultant. Janssen – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus – Consultant. Roche – Consultant. Salix – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Theravance – Consultant.

Hans Herfarth: Alivio – Consultant. Artizan – Grant/Research Support. BMS – Advisory Committee/Board Member. Boehringer – Advisory Committee/Board Member. ExeGi – Consultant. Finch – Consultant. Gilead – Consultant. Janssen – Consultant. NovoNordisk – Grant/Research Support. Pfizer – Grant/Research Support.