Corticosteroid Use among Patients with Crohn's Disease and Ulcerative Colitis on Advanced Therapy from the CorEvitas Inflammatory Bowel Disease Registry

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 2 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 1). 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. Conclusion: 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. Table 1. - 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 CD CS-free remissionN=803 CS-use remissionN=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 remissionN=439 CS-use remissionN=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 *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.