P2690 - Comparing Cortiment® and Prednisone in Ulcerative Colitis: A Population-based Study of Outcomes

Stephanie Coward, PhD¹, Karen Martins, PhD², Scott Klarenbach, MD, MSc², Karen Kroeker, MD, MSc, FRCPC², Christopher Ma, MD¹, Remo Panaccione, MD, FRCP³, Lawrence Richer, MD, MSc², Cynthia H. Seow, MBBS (Hons), MSc, FRACP¹, Laura Targownik, MD⁴, Gilaad Kaplan, MD, MPH^1
1University of Calgary, Calgary, AB, Canada; ²University of Alberta, Edmonton, AB, Canada; ³Inflammatory Bowel Disease Clinic, Gastrointestinal Research, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; ⁴Mount Sinai Hospital, Toronto, ON, Canada

Introduction: In August 2016 Cortiment® was approved for use in ulcerative colitis (UC) patients in Canada, but not approved for reimbursement; the Canadian Agency for Drugs and Technology in Health cited no comparable benefit for its use over other approved UC medications. Real-world data comparing Cortiment® to other UC medications is limited, especially during the COVID-19 pandemic where the use of steroids is counter-indicated for COVID-19-related outcomes.

Methods: Using population-based data from Alberta Canada, two cohorts were compared: 1. Cortiment® (all patients dispensed Cortiment® with a diagnostic code for UC [ICD-9-CM: 556.X; ICD-10-CA: K51.X] from August 1, 2016 to October 31, 2019; and, 2. Prednisone (UC patients identified through a validated algorithm and dispensed a >30 day supply or >500mg in 24 hours of prednisone [ATC: H02AB07] or prednisolone [ATC: H02AB06] from April 1, 2016 to October 31, 2019). Both cohorts were followed to identify hospitalizations (all, IBD-related, or IBD-specific), IBD-surgery, or infections (i.e., pneumonia, c.diff, sepsis, tuberculosis) that occurred within 6 or 12 months from the first dispensing of either medication. Cox-proportional hazard models were created to assess outcomes between the two groups (using age and sex as possible modifiers/confounders and assessing the proportional hazard assumption of each model), Kaplan-Meier survival curves were created, and Poisson regression (or negative binomial) used to assess the Average Monthly Percentage Change (AMPC) with associated 95% confidence intervals (CI).

Results: The Cortiment® cohort had 917 patients and the Prednisone cohort had 2,404 patients. Over the study period, dispensing of prednisone significantly decreased (AMPC: -2.53% [CI: -2.85, -2.21]) while Cortiment® remained stable (AMPC: 0.86% [CI: -0.04, 1.78]). Dispensing of Cortiment® significantly decreased the hazard of hospitalization (all types, except surgery) at 12 months as compared to prednisone, and significantly decreased the hazard of individuals acquiring an infection at both 6 and 12 months (Table 1 and Figure 1).

Discussion: The use of Cortiment® in a real-world setting lead to fewer deleterious outcomes as compared to prednisone, and its use during a pandemic should be preferred, especially when it’s counterpart (prednisone/prednisolone) can exacerbate negative COVID-19-related outcomes.


Figure: Kaplan-Meier Survival Curves of 1-year Outcomes: A) All Hospitalizations; B) IBD-Related Hospitalizations; C) IBD-Specific Hospitalizations; and, D) Any Infection. [Dashed Line: Cortiment Cohort; Solid Line: Prednisone/Prednisolone Cohort; IBD: Inflammatory Bowel Disease]

		Cortiment (%)	Prednisone (%)
	N	917	2404
Age	Median (Q1; Q3)	45.9 (33.3, 58.5)	43.9 (31.8, 59.1)
Sex	Male	430 (46.9)	1,356 (56.4)
	Female	487 (53.1)	1,048 (43.6)
Cox Proportional Hazard Models
		Cortiment n (%)	Prednisone n (%)	HR (95%CI)
All Hosp	6-months	107 (11.67)	409 (17.0)	0.83 (0.63, 1.11)*
	1-year	152 (16.58)	592 (24.6)	0.64 (0.54, 0.77)¥
IBD-Related	6-months	72 (7.85)	279 (11.6)	0.67 (0.52, 0.87)□
	1-year	102 (11.12)	394 (16.4)	0.66 (0.53, 0.82)¥
IBD-Specific	6-months	58 (6.32)	223 (9.28)	0.91 (0.63, 1.32)£
	1-year	79 (8.62)	312 (12.98)	0.66 (0.51, 0.84)□
IBD-Surgery	6-months	13 (1.42)	57 (2.37)	0.61 (0.33, 1.11)ᵝ
	1-year	24 (2.62)	101 (4.20)	1.05 (0.61, 1.82)£
Infection	6-months	25 (2.73)	152 (6.32)	0.43 (0.28, 0.65)ᵝ
	1-year	41 (4.47)	213 (8.86)	0.49 (0.35, 0.69)□

Table: Description of Cortiment and Prednisone Cohorts; and, Results from Cox Proportional Hazard Models Comparing Cortiment and Prednisone Cohorts for all Outcomes at 6-months and 1-year

Bold & Italic = Significant; N: number; IBD: Inflammatory Bowel Disease; HR: Hazard Ratio; CI: Confidence Interval; [*] : Sex Modification; [¥] : Proportional Hazards Assumption violated with the inclusion of age or sex in the model. Therefore, model does not include either.; [□]: Sex Adjusted; [£] : Age-Adjusted and Sex modification; [ᵝ] : Age- and Sex-Adjusted




Disclosures:
Stephanie Coward indicated no relevant financial relationships.
Karen Martins indicated no relevant financial relationships.
Scott Klarenbach: Ferring – Grant/Research Support.
Karen Kroeker indicated no relevant financial relationships.
Christopher Ma: Ferring – Consultant, Speaker's Bureau.
Remo Panaccione indicated no relevant financial relationships.
Lawrence Richer indicated no relevant financial relationships.
Cynthia Seow indicated no relevant financial relationships.
Laura Targownik indicated no relevant financial relationships.
Gilaad Kaplan: Ferring – Grant/Research Support.


Stephanie Coward, PhD¹, Karen Martins, PhD², Scott Klarenbach, MD, MSc², Karen Kroeker, MD, MSc, FRCPC², Christopher Ma, MD¹, Remo Panaccione, MD, FRCP³, Lawrence Richer, MD, MSc², Cynthia H. Seow, MBBS (Hons), MSc, FRACP¹, Laura Targownik, MD⁴, Gilaad Kaplan, MD, MPH¹. P2690 - Comparing Cortiment® and Prednisone in Ulcerative Colitis: A Population-based Study of Outcomes, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.