COMPARING REAL-WORLD OUTCOMES, MEASURED AS 12 AND 24-MONTH IBD-RELATED SURGERIES, BETWEEN INFLIXIMAB DOSE OPTIMIZED PATIENTS USING THERAPEUTIC DRUG MONITORING (TDM) VS AN UNOPTIMIZED CONTROL GROUP, IN A LARGE US COMMUNITY-BASED GASTROENTEROLOGY PRACTICES

Abstract

Abstract BACKGROUND Anti-TNFs such as infliximab (IFX) continue to be the standard of care to treat moderate-to-severe IBD. Remission and reducing detrimental outcomes are achievable goals when therapeutic drug monitoring (TDM) is implemented to assist with IFX therapy optimization. TDM aids in achieving & maintaining adequate drug exposure to avoid loss of response by offering actionable information to guide treatment adjustments. The value of TDM has been described in numerous studies which show that optimization of anti-TNFs correlates with improved clinical outcomes & the use of TDM is recommended by IBD guidelines and expert consensus. A potential evidence gap is the lack of real-world outcomes data when Anser®, a TDM test, is implemented in a community setting. OBJECTIVE Describe & compare the real-world outcomes, measured as IBD-related surgeries, in IFX dose optimized patients using Anser® TDM as part of ongoing IBD care as compared to a no TDM control group in a community-based practice setting. METHODS De-identified patient charts from a US-based community gastroenterology practice were analyzed for all patients (ages 8 to 89) treated with IFX from 2016 to 2022. Matching records to Prometheus Laboratories test results were then tokenized. Two cohorts were structured, Anser TDM as part of ongoing IBD care & no TDM. Groups were matched by propensity score, baseline disease, demographics, and comorbidities for comparison. Real-world outcomes were accessible via Lynx.MD online database. Analysis was conducted, stratifying patients as all IFX patients or anti-TNF naïve patients (TNF-N), to compare the percentage of IBD-related surgeries for 12 or 24-month outcomes. IBD surgeries were recorded in patient charts as colectomies, surgeries for fistula, bowel perforations, drainage of abscesses, adhesiolysis and other surgical bowel procedures. Statistical analysis was completed by Lynx.MD. RESULTS The size of Anser TDM (n= 235 to 337) and no TDM (n= 223 to 321) cohorts varied depending on the analysis criteria. Crohn’s disease was majority (2/3) and median age ranged from 36 to 39. For all IFX patients the 12-month outcomes of any IBD surgery was 1.2% for Anser TDM vs 6.5% for no TDM (5.4%, P=0.001). For TNF-N patients, the rate was 1% and 6.8%, respectively (5.7%, P=0.001). The results for 24-month outcomes for all IFX patients were 4.1% for Anser TDM vs 9.8% for no TDM (4.1%, p=0.016), and 4.3% vs 9% respectively for TNF-N (4.8%, P=0.06). CONCLUSIONS Real-world outcomes data for 12 and 24-months demonstrate that the Anser IFX TDM group had significantly lower rates of IBD surgeries for all patients, including for 12-month outcomes in TNF-N. This finding provides the first analysis, on Anser® TDM used to optimize patient’s IFX dosing, in comparison to a matched cohort of no TDM patients within the same community gastroenterology clinic setting.