Early Biologic Therapy in Inflammatory Bowel Disease Patients Is Associated With Improved Outcomes and Reduced Unplanned Care - A Nationwide Analysis

Introduction: Inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic inflammatory conditions characterized by a relapsing and remitting course. Evidence supports earlier use of anti–tumor necrosis factors especially in CD but the benefit of early administration of newer classes of biologic therapy remains unclear with less data in UC. Methods: TriNETX, a multicenter research network pulling data from 80 participating health organizations in the US was analyzed. IBD patients were identified using ICD-10 codes K50 and K51. Biologics studied included Adalimumab, Golimumab, Infliximab, Natalizumab, Tofacitinib, Certolizumab, Vedolizumab or Ustekinumab. Population was divided into early group; patients who received a biologic within 2 years of diagnosis, and late group; patients who first received a biologic after 2 years of diagnosis. Patients with an outcome prior to biologic administration were excluded from analysis. Results: A total of 102,058 IBD patients on a biologic were identified. Out of which, 77,528 patients received a biologic within 2 years of diagnosis vs 24,530 patient first received a biologic after 2 years of diagnosis. Compared to the late biologic, early biologic IBD patients were significantly less likely to develop Clostridiodes difficile infection (CDI) (OR 0.80 CI 0.76-0.84), total colectomy (OR 0.81 CI 0.78-0.84), pouchitis (OR 0.73 CI 0.67-0.80), deep venous thrombosis (DVT) (OR 0.71 CI 0.67-0.76) and Pulmonary embolism (PE) (OR 0.68 CI 0.62-0.75). When stratified by UC or CD, the results were similar: UC patients who received early biologic were significantly less likely to have CDI (OR 0.83 CI 0.77-0.89), total colectomy (OR 0.86 CI 0.81-0.91), pouchitis (OR 0.76 CI 0.66-0.87), DVT (OR 0.80 CI 0.73-0.89) and PE (OR 0.76 CI 0.66-0.87), and CD early biologics, lower CDI (OR 0.78 CI 0.72-0.83), total colectomy (OR 0.78 CI 0.75-0.81), partial colectomy (OR 0.91 CI 0.86-0.96), DVT (OR 0.67 CI 0.62-0.73) and PE (OR 0.63 CI 0.57-0.71). Unplanned care was also less likely in the early biologic groups with UC emergency room visits OR 0.66 and hospitalizations OR 0.80, and CD emergency room visits OR 0.68 and hospitalizations OR 0.73. Conclusion: Early biologic therapy for IBD was associated with decreased IBD complications and surgeries. There was also a significant reduction in unplanned care with fewer emergency room visits and hospitalizations (Table 1). Table 1. - Study results Inflammatory Bowel Disease Biologics Within 2 years Biologics After 2 years P OR/CI Number of patients 77,528 24,530 Demographics Age 37.6 (+/-17.4) 37.8 (+/-17.1) < 0.0001 Female 39,512 (52.3%) 12,274 (54.5%) < 0.0001 Outcomes Emergency visit 17,418 (27.67%) 6,845 (35.8%) < 0.0001 0.68 (0.66-0.70) Inpatient admission 20,436 (33.1%) 7,452 (39.3%) < 0.0001 0.76 (0.73-0.79) CDI 5,176 (6.9%) 1,899 (8.5%) < 0.0001 0.80 (0.76-0.84) Total Colectomy 14,540 (19.7%) 5,146 (23.2%) < 0.0001 0.81 (0.78-0.84) Partial Colectomy 7,197 (0.95%) 2,156 (9.63%) 0.8124 0.99 (0.94-1.04) Pouchitis 1,961 (2.6%) 784 (3.5%) < 0.0001 0.73 (0.67-0.80) DVT 3,067 (4.1%) 1,259 (5.63%) < 0.0001 0.71 (0.67-0.76) PE 1,502 (2%) 647 (2.8%) < 0.0001 0.68 (0.62-0.75) Ulcerative Colitis Number of patients 30,483 10,436 Emergency visit 6,398 (26.4%) 2,835 (35.1%) < 0.0001 0.66 (0.62-0.7) Inpatient admission 7,469 (32%) 2,921 (36.8%) < 0.0001 0.80 (0.76-0.85) C-Diff 2,674 (9.1%) 1,034 (10.8%) < 0.0001 0.83 (0.77-0.89) Total Colectomy 4,826 (16.5%) 1,773 (18.7%) < 0.0001 0.86 (0.81-0.91) Partial Colectomy 2,300 (7.7%) 609 (6.3%) < 0.0001 1.24 (1.1-1.3) Pouchitis 1,498 (5.0%) 652 (6.8%) < 0.0001 0.72 (0.66-0.8) DVT 1,419 (4.8%) 565 (5.9%) < 0.0001 0.80 (0.73-0.89) PE 695 (2.3%) 294 (3.0%) 0.0001 0.76 (0.66-0.87) Crohn’s Disease Number of patients 54,384 16,768 Emergency visit 12,503 (28.6%) 4,732 (36.8%) < 0.0001 0.68 (0.65-0.71) Inpatient admission 14,441 (33.84%) 5,203 (41.0%) < 0.0001 0.73 (0.70-0.76) C-Diff 3,114 (5.9%) 1,138 (7.5%) < 0.0001 0.78 (0.72-0.83) Total Colectomy 11,131 (21.8%) 3,921 (26.2%) < 0.0001 0.78 (0.75-0.81) Partial Colectomy 5,588 (10.6%) 1,753 (11.5%) 0.0013 0.91 (0.86-0.96) DVT 2,039 (3.8%) 856 (5.6%) < 0.0001 0.67 (0.62-0.73) PE 983 (1.8%) 440 (2.8%) < 0.0001 0.63 (0.57-0.71)