EFFECTIVENESS OF ANTI-TNF THERAPY COMPARED TO IMMUNE MODULATOR FOR PREVENTION OF SURGICAL RECURRENCE IN PEDIATRIC CD

Abstract

Abstract BACKGROUND Crohn’s disease (CD) is an immune-mediated, chronic inflammatory disease without a present cure. Surgical intervention for disease complications is common among CD patients, however post-operative strategies to prevent disease recurrence represent a critical knowledge gap, particularly in the pediatric CD population. Although adult CD data suggest effectiveness of anti-Tumor Necrosis Factor (TNF) therapies for prevention of recurrence, similar evidence is scarce for the pediatric population. We sought to evaluate the effectiveness of anti-TNF monotherapy compared to immune modulator (methotrexate or thiopurine) monotherapy for prevention of surgical recurrence in pediatric CD patients using a large, geographically diverse administrative claims database. METHODS We analyzed pediatric (≤18 years) patients with CD who underwent ≥1 intestinal resection within the IQVIA Legacy PharMetrics Adjudicated Claims database between 2007 and 2018. IQVIA data contain longitudinal, de-identified patient-level claims for medical, surgical, and pharmacy encounters. IQVIA captures over 100 health plans with nearly 80 million insurance plan enrollees. We selected patients with ≥1 International Classification of Diseases 9thor 10thclinical modification (ICD-9/10) code for CD and ≥1 Current Procedural Terminology (CPT) code for a large and/or small bowel resection. We excluded patients with ≥3 encounters with an ICD-9/10 diagnosis code for ulcerative colitis (UC) or ≥1 UC code in the month of the index resection. We identified patients prescribed anti-TNF monotherapy and those prescribed immune modulators (thiopurine or methotrexate) monotherapy within 90 days of resection and compared rates of surgical recurrence. Analyses included descriptive statistics for the post-surgical cohort as well as time to surgical recurrence using Kaplan-Meier curves. RESULTS A total of 399 pediatric CD patients underwent an intestinal resection between 2007-2018 within the IQVIA database. Among those, 212 were prescribed either an anti-TNF monotherapy (109; 51%) or immune modulator monotherapy (103; 49%) within 90 days of resection. The median age of the treated cohort was 16 years (interquartile range (IQR) 14, 17) with 48% females. Over 60% of intestinal resections were ileo-cecectomies/colectomies. Thirteen (6.1%) patients required a repeat resection. Differences in median time to surgical recurrence were not statistically significant (Figure 1). Post-operative therapy was highly correlated with pre-operative therapy (p-value <0.001). CONCLUSION Our results do not suggest a clear benefit of anti-TNF monotherapy versus immune modulator therapy for post-operative prophylaxis of pediatric Crohn’s disease. Randomized comparative effectiveness trials evaluating a range of outcomes including clinical and endoscopic recurrence are needed.