Real-World Treatment Patterns and Outcomes of Vedolizumab VS. ANTI-Tumor Necrosis Factor in Biologic-Naive Ulcerative Colitis Patients in a Nationwide Healthcare Provider Database in Israel
Author(s)
Weil C1, Chodick G2, Tsukinovsky S3, Ben Baruch O3, Barak M4, Sommer A3
1Maccabi Healthcare Services, Tel Aviv, TA, Israel, 2Maccabi Healthcare Services & Tel Aviv University, Tel Aviv, Israel, 3Takeda Pharmaceuticals, Petach Tikvah, Israel, 4Takeda Pharmaceuticals, Hod Ha’sharon, Israel
OBJECTIVES: To compare treatment patterns and outcomes of vedolizumab (VDZ) vs. anti-tumor necrosis factor (anti-TNF) in biologic-naïve ulcerative colitis (UC) patients. METHODS: A retrospective cohort study was performed using the databases of Maccabi Healthcare Services, a 2.4-million-member healthcare provider in Israel. Adult UC patients initiating anti-TNF (IFX, ADA) or VDZ in 2017-2018 after ≥12 months without any biologic use (biologic-naïve) were followed through 31/09/2019. Biologic treatment patterns and corticosteroid discontinuation were described. Outcomes included (1) UC-related hospitalization, (2) UC-related surgery and (3) flare/composite outcome (CO) of outcomes 1-2, intravenous corticosteroids or diagnosed abdominal pain. Cumulative events % at 365 days was estimated with Kaplan-Meier analysis (unadjusted). Cox proportional hazards analysis was performed, with inverse probability‐of‐treatment weighting (IPTW) to account for differences in baseline characteristics, UC-related treatments, hospitalizations and surgery, comorbidities and laboratory test results. RESULTS: The cohort included 85 VDZ (median age=41y, males=50.6%) and 84 anti-TNF (median age=36.5y, males=56.0%) initiators. VDZ vs. anti-TNF initiators did not differ significantly in age, disease duration (% treated within 2y=32.9% vs. 27.4%) and prior UC-surgeries (3.5% vs. 2.4%). Time-to-discontinuation was significantly longer for VDZ vs. anti-TNF (% discontinued at 365 days=47.3% vs. 66.9%; with IPTW, the adjusted hazard ratio (aHR) was 0.58 (95%CI=0.38-0.88). Risk of flare/CO was significantly lower in VDZ vs. anti-TNF (aHR=0.37; 95%CI=0.20-0.67); for UC-hospitalization the difference did not reach statistical significance (aHR=0.49; 0.22-1.1). There were no statistically significant differences in surgery (1 event), dose escalation (% escalated at 365 days=18.2% in both groups) or corticosteroid discontinuation. CONCLUSIONS: In this real-world biologic-naive UC cohort, VDZ users experienced significantly fewer flares and were less likely to discontinue treatment, compared to anti-TNF. Further analyses in a larger cohort are planned for UC, as well as for Crohn’s disease where the relatively smaller biologic-naïve VDZ cohort to date limited the statistical power for comparative analyses.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PGI2
Topic
Clinical Outcomes, Epidemiology & Public Health, Health Service Delivery & Process of Care, Real World Data & Information Systems
Topic Subcategory
Comparative Effectiveness or Efficacy, Health & Insurance Records Systems, Safety & Pharmacoepidemiology, Treatment Patterns and Guidelines
Disease
Biologics and Biosimilars, Gastrointestinal Disorders