C0360 - The Progression of Crohn’s Disease: Results From an Observational Study Using U.S. Claims Data

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Gil Y. Melmed, MD

Cedars Sinai Medical Center
Los Angeles, CA

Yanni Fan, PhD¹, Ling Zhang, MPH¹, Negar Omid, PhD², Rhonda L. Bohn, PhD², Adepero S. Adewale, PhD¹, Gil Y. Melmed, MD³
¹Boehringer Ingelheim Corporation, Ridgefield, CT; ²Bohn Epidemiology LLC, Boston, MA; ³Cedars-Sinai Medical Center, Los Angeles, CA

Introduction: Crohn’s disease (CD) is a chronic progressive inflammatory disease of the gastrointestinal tract. Disease progression is characterized by the occurrence of CD complications, including fistula, intestinal stenosis, and abscess. The aim of this study was to characterize progression among patients with CD without complications.

Methods: This cohort study used data from the Optum claims database from 01/2016 to 06/2020. Patients without a previous CD diagnosis between 01/2017 and 06/2019 were considered as newly diagnosed cases; those with a previous CD diagnosis prior to the index date (CD diagnosis date) or 01/2017 were considered as existing cases. Patients with a history of CD progression were excluded. The primary objective was to estimate the risk of and time to progression from the time of CD diagnosis in patients newly diagnosed with CD without complications at baseline. Risk of progression (proportion of patients at risk who progressed) was estimated for both newly diagnosed and existing CD cases at 6 months and 1, 2, and 3 years. Kaplan–Meier estimates for time to progression (duration between index date and first progression event) were generated for newly diagnosed CD cases. Other outcomes e.g., demographic characteristics, were assessed over the follow-up period (between index date and 06/2020) using descriptive statistics.

Results: In total, 23,241 patients (mean age 47.1 years [standard deviation 18.7]; 42.3% female) with CD were identified; 29.3% (n=6804) were newly diagnosed and 70.7% (n=16,437) were existing cases. The most common comorbidities in newly diagnosed and existing cases were obesity (25.4%; 18.4%), anxiety (24.5%; 21.9%), and depression (22.1%; 18.7%); extraintestinal manifestations (2.4%; 3.8%). The most common CD-related medication was antibiotics for newly diagnosed (25.2%; 18.3% existing) and acetylsalicylic acid for existing cases (27.5%; 13.1% newly diagnosed). Risk of CD progression over time ranged from 19.3% to 26.6% in newly diagnosed and 8.2% to 21.4% in existing cases (Table). A total of 6804 patients with newly diagnosed CD progressed with a median time to progression of 709 days (interquartile range: 415–987) (Figure).

Discussion: Over 20% of all patients with CD experienced progression during the follow-up period. Intestinal stenosis was a more common complication than fistula or abscess.

Figure: Figure. Time to Crohn’s disease progression events for newly diagnosed cases
Time from CD diagnosis to progression event was assessed for the entire follow-up period for newly diagnosed cases only and was estimated as the time from the index date (date of the first CD diagnosis) to the progression date. If no such progression event was observed in the available follow-up period, the patient was censored.
CD, Crohn’s disease; IQR, interquartile range.

	Period post-index date*
	Total follow-up period		6 months		1 year		2 years		3 years
	Newly diagnosed cases	Existing cases	Newly diagnosed cases	Existing cases	Newly diagnosed cases	Existing cases	Newly diagnosed cases	Existing cases	Newly diagnosed cases	Existing cases
Patients at risk of CD progression, n	6804	16,437	6117	15,182	5503	13,720	3875	11,238	1668	7856
Patients with CD progression^†, n (%)	1714 (25.2)	3288 (20.0)	1183 (19.3)	1241 (8.2)	1188 (21.6)	1622 (11.8)	953 (24.6)	1879 (16.7)	444 (26.6)	1680 (21.4)
CD fistula (diagnosis or surgery)	430 (6.3)	990 (6.0)	270 (4.4)	327 (2.2)	293 (5.3)	456 (3.3)	259 (6.7)	535 (4.8)	125 (7.5)	499 (6.4)
Intestinal stenosis (stricture diagnosis or surgery)	1227 (18.0)	2211 (13.5)	843 (13.8)	798 (5.3)	845 (15.4)	1050 (7.7)	655 (16.9)	1224 (10.9)	320 (19.2)	1106 (14.1)
Intestinal abscess (diagnosis or drainage procedure)	443 (6.5)	729 (4.4)	275 (4.5)	259 (1.7)	293 (5.3)	372 (2.7)	269 (6.9)	464 (4.1)	112 (6.7)	411 (5.2)
Patients who underwent CD-related surgery, n (%)	354 (5.2)	684 (4.2)	198 (3.2)	214 (1.4)	217 (3.9)	305 (2.2)	206 (5.3)	417 (3.7)	95 (5.7)	384 (4.9)

Table: Table. Risk of Crohn’s disease progression
*Date of the first CD diagnosis.
†A patient was considered to have CD progression if they had a diagnosis CD-related fistula, intestinal stenosis, or abscess, or underwent a CD-related surgery after the index date, whichever event occurred first. The date of the first of these progression events was considered the progression date.
CD, Crohn’s disease.

Disclosures:

Yanni Fan: Boehringer Ingelheim – Employee.

Ling Zhang: Boehringer Ingelheim – Employee.

Negar Omid: Boehringer Ingelheim – Consultant. Bohn Epidemiology – Employee.

Rhonda Bohn: Boehringer Ingelheim – Consultant. Bohn Epidemiology – Employee.

Adepero Adewale: Boehringer Ingelheim – Employee.

Gil Melmed: AbbVie – Consultant. Arena – Consultant. Boehringer Ingelheim – Consultant. Bristol Meyers Squibb – Advisor or Review Panel Member, Consultant. Entasis – Consultant. Janssen – Consultant. Medtronic – Consultant. Pfizer – Consultant, Grant/Research Support. Samsung Bioepis – Consultant. Shionogi – Advisor or Review Panel Member. Takeda – Consultant. TechLab – Consultant.

Yanni Fan, PhD¹, Ling Zhang, MPH¹, Negar Omid, PhD², Rhonda L. Bohn, PhD², Adepero S. Adewale, PhD¹, Gil Y. Melmed, MD³. C0360 - The Progression of Crohn’s Disease: Results From an Observational Study Using U.S. Claims Data, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.