P0687 - Corticosteroid Use Among Patients With Crohn’s Disease and Ulcerative Colitis on Advanced Therapy From the CorEvitas Inflammatory Bowel Disease Registry

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Raymond Cross, MD

University of Maryland
Lutherville-Timonium, MD

Raymond Cross, MD¹, Jenny Griffith, PharmD², Michelle R. Kujawski, PhD², Alicia Beeghly, PhD³, Nicole Middaugh, DSc³, Page Moore, PhD³, C. Jean Choi, MS³, Marie Gurrola, MPH³, Dolly Sharma, PhD²
¹University of Maryland, Baltimore, MD; ²AbbVie Inc., North Chicago, IL; ³CorEvitas, Waltham, MA

Introduction: Corticosteroids (CS) are a cornerstone of treatment for Inflammatory Bowel Disease (IBD), but prolonged use may lead to a range of deleterious side effects. This study characterized systemic CS use by disease activity (remission vs active disease) among patients (pts) with Crohn’s disease (CD) and ulcerative colitis (UC) in a real-world setting.

Methods: This cross-sectional analysis included pts with CD or UC who had been on an advanced therapy (including biologics and small molecules) for ≥3 months from the CorEvitas IBD Registry from May 2017–March 2023. Patient and disease characteristics at the index visit, defined as the latest registry visit at which a patient had active disease or was in remission, were described. Pts in remission were further categorized into two mutually exclusive groups based on physician-reported use of systemic CS within 30 days prior to the index visit as CS-use and CS-free.

Results: A total of 1351 pts with CD (active disease: 370, remission: 981) and 894 pts with UC (active disease: 333, remission: 561) were evaluated (Table). For CD and UC, 28.9% and 36.6% of pts with active disease and 18.1% and 21.8% of pts in remission had systemic CS use, respectively. Demographic and other patient characteristics were generally similar, as >50% of the study population were white females. In pts with CD, mean (SD) time since IBD symptom onset was 13.8 (11.8), 12.3 (11.1), and 16.3 (12.9) in pts with CS-free remission, CS-use remission, and active CD, respectively. For pts with UC, mean (SD) time since IBD symptom onset was 12.5 (10.6), 9.4 (6.6), and 10.7 (9.4) in pts with CS-free remission, CS-use remission, and active UC, respectively. Among pts in remission with CS-use, 63.5% and 38.8% of those with CD (n=178) and 74.6% and 31.2% of those with UC (n=122) had systemic prednisone and budesonide use, respectively. However, only 25.3% and 37.7% of these CD and UC pts, respectively, had a prednisone taper within 6 months prior to their index visit.

Discussion: Results from this real-world analysis of pts from the CorEvitas IBD Registry indicate that systemic CS use is common among pts on advanced therapy, even when in remission. Among pts in remission with prednisone use, less than half had undergone tapering within the preceding 6 months. While information on budesonide tapers was not collected, these findings indicate possible missed opportunities to reduce long term CS use among pts with CD and UC.

CD	CS-free remission N=803	CS-use remission N=178	Active Disease (mild/moderate/severe) N=370
CD	CS-free remission N=803	CS-use remission N=178	Active Disease (mild/moderate/severe) N=370
Female, n/N (%)	412/797 (51.7)	97/176 (55.1)	224/367 (61.0)
Race
White	677/795 (85.2)	145/176 (82.4)	314/366 (85.8)
Black/African American	61/795 (7.7)	22/176 (12.5)	33/366 (9.0)
Asian	16/795 (2.0)	^a	6/366 (1.6)
Other	41/795 (5.2)	^a	13/366 (3.6)
Systemic steroid use, n (%)^b	0 (0.0)	178 (100.0)^†‡	107 (28.9)
Systemic budesonide, n (%)^c	0 (0.0)	69 (38.8)^‡	47 (12.7)
Budesonide current dose (mg/day)^d
N	0	25	24
Mean ± SD	NA ± NA	8.2 ± 2.2	9.0 ± 2.3
Systemic Prednisone, n (%)	0 (0.0)	113 (63.5)^‡	67 (18.1)
Prednisone current dose (mg/day)
N	0	31	20
Mean ± SD	NA ± NA	21.7 ± 12.5	23.8 ± 13.4
Prednisone taper received in past 6 months, n (%)	16 (2.0)	45 (25.3)	30 (8.1)
Dose ≥10 mg/day
N	0	27	19
Mean ± SD	NA ± NA	24.1 ± 11.5	24.7 ± 13.0
Duration of current IBD therapy (years)
N	800	178	369
Mean ± SD	2.5 ± 2.9	2.0 ± 2.0	1.7 ± 1.8
UC	CS-free remission N=439	CS-use remission N=122	Active Disease (mild/moderate/severe) N=333
UC	CS-free remission N=439	CS-use remission N=122	Active Disease (mild/moderate/severe) N=333
Female, n/N (%)	233/434 (53.7)	63/122 (51.6)	178/330 (53.9)
Race, n/N (%)
White	367/432 (85.0)	102/121 (84.3)	274/329 (83.3)
Black/African American	26/432 (6.0)	8/121 (6.6)	24/329 (7.3)
Asian	17/432 (3.9)	6/121 (5.0)	10/329 (3.0)
Other	22/432 (5.1)	5/121 (4.1)	21/329 (6.4)
Systemic steroid use, n (%)^b	0 (0.0)	122 (100.0)^*^†‡	122 (36.6)
Systemic budesonide, n (%)^c	0 (0.0)	38 (31.2)^‡	29 (8.7)
Budesonide current dose (mg/day)^d
N	0	14	22
Mean ± SD	NA ± NA	8.8 ± 1.9	9.6 ± 3.0
Systemic Prednisone, n (%)	0 (0.0)	91 (74.6)^‡	97 (29.1)
Prednisone current dose (mg/day)
N	0	22	41
Mean ± SD	NA ± NA	19.6 ± 13.7	25.1 ± 13.4
Prednisone taper received in past 6 months, n (%)	19 (4.3%)	46 (37.7%)	51 (15.3%)
Dose ≥10 mg/day
N	0	18	39
Mean ± SD	NA ± NA	22.9 ± 13.0	26.0 ± 13.0
Duration of current IBD therapy (years)
N	405	121	316
Mean ± SD	2.4 ± 2.4	1.8 ± 1.6	1.4 ± 1.6

Table: Treatment characteristics by steroid use and disease activity for patients with UC and CD on advanced therapy for ≥3 months at index visit from the CorEvitas IBD Registry.
*Large standardized effect size ≥0.5 for Cohen’s w for CS-free vs active disease; †large standardized effect size ≥0.5 for Cohen’s w for CS-use vs active disease; ‡large standardized effect size ≥0.5 for Cohen’s w for CS-use vs CS-free.
an<5; data not displayed to avoid the potential of identifying individual patients.
bSystemic steroids include budesonide/Entocort EC, budesonide extended release/Uceris MMX, prednisone, other.
cBudesonide includes Entocort EC and Uceris MMX.
dTaper information not collected for budesonide.
CD, Crohn’s disease; CS, corticosteroid; NA, not available; SD, standard deviation; UC, ulcerative colitis.

Disclosures:

Raymond Cross: Abbvie – Advisory Committee/Board Member, Consultant. Adiso – Advisory Committee/Board Member. BMS – Advisory Committee/Board Member. CorEvitas Registry – Scientific co-director. Frensenius Kabi – Advisory Committee/Board Member, Consultant. Fzata – Consultant. IBD Executive Group – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Grant/Research Support. Magellan Health – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Samsung bioepis – Consultant. Sebela – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member.

Jenny Griffith: AbbVie/Abbott – Employee, Stock Options.

Michelle R. Kujawski: AbbVie – full-time employee of AbbVie, and might hold AbbVie stock or stock options.

Alicia Beeghly: CorEvitas – Employee.

Nicole Middaugh: CorEvitas – Employee.

Page Moore: CorEvitas – Employee.

C. Jean Choi: CorEvitas – Employee.

Marie Gurrola: CorEvitas – Employee.

Dolly Sharma: AbbVie/Abbott – Employee, Stock Options.

Raymond Cross, MD¹, Jenny Griffith, PharmD², Michelle R. Kujawski, PhD², Alicia Beeghly, PhD³, Nicole Middaugh, DSc³, Page Moore, PhD³, C. Jean Choi, MS³, Marie Gurrola, MPH³, Dolly Sharma, PhD². P0687 - Corticosteroid Use Among Patients With Crohn’s Disease and Ulcerative Colitis on Advanced Therapy From the CorEvitas Inflammatory Bowel Disease Registry, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.