S1015 Adverse Events and Compliance Among Inflammatory Bowel Disease Patients Treated With Home versus Office-Based Biologic Infusions

Abstract

Introduction: Home infusion of infliximab (IFX) and vedolizumab (VDZ) for inflammatory bowel disease (IBD) has recently expanded owing to insurance company requirements and patient (pt) preference for convenience. These biologics are associated with a number of adverse events (AEs). Previous data suggest increased rates of AEs and reduced efficacy of biologics when given at home rather than in a medical office. We sought to assess the rates of AEs, biologic discontinuation, and adherence to follow-up in IBD pts receiving home versus office-based infusions. Methods: This was a single center retrospective cohort study of adult pts with IBD receiving IFX or VDZ either at home or an office-based infusion center. AEs were defined as immediate (< 24 hour) and delayed (day 1-7) transfusion reaction, steroid initiation, drug discontinuation, or IBD-related emergency room visits, admission, and surgery. Patients were followed for a maximum duration of 150 weeks. Adherence to follow-up was determined by biannual clinic visits and labwork. Chi squared and Fisher’s exact tests were used, where appropriate, to determine statistical significance. Kaplan-Meier plot created using SPSS software. Results: 287 pts (46.0% female, mean age 40.8 years, 61.3% CD, 38.7% UC) were included. The majority were non-Hispanic white with an elevated BMI. The office-based infusion group had more former smokers (35.9% vs 19.0%, p< 0.05), longer disease duration (11.2 vs 8.1 years, p< 0.05), and greater disease severity (Harvey-Bradshaw Index (HBI) 4.9 vs 3.8, p< 0.05) compared to the home infusion group (Table). AEs were higher among office-based infusions (80 vs 56, p< 0.05) driven by delayed transfusion reactions (4 vs 0, p < 0.05), surgery (6 vs 0, p < 0.05), and medication discontinuation (44 vs 35, p < 0.05) (Figure). Pts receiving home infusions were less likely to follow-up in clinic (53.2% vs 71.4%, p< 0.05) and obtain routine labwork (37.9% vs 58.1%, p< 0.05). Conclusion: Among IBD pts on IFX or VDZ therapy, office-based infusions were associated with higher rates of AEs especially delayed transfusion reactions, need for surgery, and medication discontinuation. Treatment bias may exist towards starting more stable patients on home infusion given the less severe disease that we observed in that group. Adherence to clinic followup and routine labwork was much lower with home infusion. Home biologic infusion appears to be a viable treatment option for IBD if adequate adherence to followup care is maintained.Figure 1.: Adverse event free survival among those on home and office based infusion of biologics for inflammatory bowel disease. Table 1. - Demographics, disease characteristics, adverse events, and compliance among inflammatory bowel disease patients receiving biologic infusion at home or at the office HomeInfusion OfficeInfusion n = 154 n = 133 Age 37.3 (12.2) 45.0 (16.4) p < 0.05 Female 81 (52.6%) 52 (39.1%) p < 0.05 Race Non-Hispanic White 131 (85.1%) 102 (77.3%) Black 12 (7.8%) 21 (15.9%) Asian 6 (3.9%) 5 (3.8%) Hispanic 4 (2.6%) 2 (1.5%) Other 1 (0.6%) 2 (1.5%) BMI 27.7 (6.5) 27.0 (6.5) Current Smoker 10 (6.5%) 10 (7.6%) Former Smoker 29 (19.0%) 47 (35.9%) p < 0.05 Disease Duration (Years) 8.1 (8.1) 11.2 (12.6) P < 0.05 Previous IBD SurgeryHarvey Bradshaw Index 39 (26.2%)3.9 (2.9) 37 (28.9%)4.8 (3.8) p < 0.05 Ulcerative Colitis 61 50 Proctitis 12 (19.7%) 13 (26%) Left-Sided 16 (26.2%) 13 (26%) Pancolitis 33 (54.1%) 24 (48%) Crohn's Disease 93 83 Ileal 25 (26.9%) 24 (28.9%) Colonic 22 (23.7%) 19 (22.9%) Ileocolonic 42 (45.2%) 40 (48.2%) Upper GI 4 (4.3%) 1 (1.2%) Inflammatory 52 (55.9%) 42 (50.1%) Stricturing 18 (19.4%) 26 (31.3%) Fistulizing 23 (24.7%) 15 (18.1%) Perianal 26 (27.1%) 21 (22.8%) Concurrent Medication Mesalamine 30 (19.6%) 44 (33.3%) P < 0.05 Thiopurines 14 (9.2%) 15 (11.4%) Methotrexate 3 (2.0%) 9 (6.8%) Biologic Use Naive 86 (56.2%) 74 (55.6%) Previous Use 67 (43.8%) 59 (44.4%) # Previous Biologics 1.4 (0.7) 1.5 (0.7) Major Adverse Event 56 80 p < 0.05 Transfusion Reaction, Immediate 8 9 Transfusion Reaction, Delayed 0 4 p < 0.05 ED Visit 0 1 Admission 7 6 Surgery 0 6 p < 0.05 Steroid Initiation 6 10 Discontinuation 35 44 p < 0.05 Office Visit Every 6 Months 53.2% 71.4% p < 0.05 Labs Obtained Every 6 Months 37.9% 58.1% p < 0.05