Background Proactive therapeutic drug monitoring (pTDM) may improve treatment outcomes in inflammatory bowel disease. Aims and methods We compared 135 patients following a prospective pTDM protocol aiming at an infliximab trough level (IFXTL) between 5 and 10 μg/ml with sequential measurements of Fc, with 108 patients from a retrospective group under conventional management. We evaluated the rates of Fc remission (<250 μg/g) and other clinical outcomes at 2-year of follow-up. Results pTDM associated with higher rates of Fc remission (69.6% vs. 50.0%; P = 0.002), and steroid-free clinical remission (78.4% vs. 55.2%, P = 0.028) with a trend for clinical remission (79.3% vs. 68.5%, P = 0.075). There was no difference in treatment discontinuation (P = 0.195), hospitalization (P = 0.156), and surgery (P = 0.110). Higher IFXTL associated with Fc remission at week 14 (6.59 vs. 2.96 μg/ml, P < 0.001), and at the end of follow-up (8.10 vs. 5.03 μg/ml, P = 0.001). In patients reaching Fc remission after week 14, IFXTL increased from week 14 to the end of follow-up (2.71 vs. 8.54 μg/ml, P < 0.001). Fc remission associated with higher rates of clinical (85.8% vs. 56.8% P < 0.001) and steroid-free clinical remission (86.9% vs. 50.0% P < 0.001), lower IFX discontinuation (8.8% vs. 36.8%, P < 0.001), and hospitalization (13.5% vs. 33.7%, P < 0.001), without significance for surgery (6.1% vs. 12.6%, P = 0.101). Conclusion pTDM was more effective than conventional management in inducing Fc remission which was associated with improved outcomes.

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Background Available evidence suggests that vedolizumab may be as effective as Infliximab (IFX) in patients with inflammatory bowel disease. However, it is unknown if proactive therapeutic drug monitoring may improve these results. Methods Retrospective study including consecutive patients under conventional management with IFX (n=108), vedolizumab (n=80) and proactive IFX (n=139) aiming at a trough level (IFXTL) between 5–10 µg/mL. We evaluated the rates of fecal calprotectin remission (&lt;250 µg/g) at week 14 and 2 years, and clinical remission, treatment discontinuation, hospitalization, and surgery at 2 years. Primary non-responders were excluded. Results Proactive IFX was superior to vedolizumab in respect to Fc remission at week 14 (56.8% vs 34.2%; P=0.001) and at 2-years (74.8% vs 35.9%, P&lt;0.001), clinical remission (79.9% vs 58.0%, P=0.001), and treatment discontinuation (24.5% vs 39.5%, P=0.015), without significance for other outcomes. These results remained significant after correcting for prior anti-TNF use (P=0.027, P&lt;0.001, P=0.01, and P=0.03). Conventional IFX was superior to vedolizumab in respect to Fc remission at 2-years (51.9% vs 35.9%, P=0.022), and treatment discontinuation (15.7% vs 39.5%, P&lt;0.001), without significance for other outcomes. However, these results were not significant after correcting for prior anti-TNF use (P=0.367 and P=0.065). Conclusion Our findings suggest that vedolizumab is as effective as conventional IFX. However, proactive IFX was superior to vedolizumab in most clinical outcomes.

Background Background: Increasing evidence supports the use of Ustekinumab (USTK) in patients with moderate to severe Crohn’s disease (CD) and Ulcerative colitis (UC). Comparison of USTK against other biologics is still lacking. Methods AIMS: to perform a propensity score analysis (PSA) for comparison of USTK against conventional Infliximab (IFX), proactive IFX and vedolizumab in CD and UC Methods retrospective study including patients under Ustekinumab (n=71), Vedolizumab (n=98), conventional IFX (n=70) and proactive IFX (n=148). PSA correcting for age, gender, IBD subtype, previous biologic exposure was performed for each comparison. We compared the rates of fecal calprotectin (Fc) remission (&lt;150 µg/g), treatment discontinuation, hospitalization, and surgery at 52 weeks of treatment. Primary non-responders were excluded. Results Results: after PSP, ustekinumab showed lower rates of treatment discontinuation compared to vedolizumab (7.4% vs 37%, P&lt; 0.001) with a trend for higher rates of Fc remission (42.6% vs 25.9%, P=0.104). Ustekinumab showed higher rates of Fc remission compared to conventional IFX (53.8% vs 19.2%, P= 0.020) with a trend for lower rates of hospitalization (7.7% vs 30.8%, P= 0.075). There were no differences between ustekinumab and proactive IFX in any of the clinical outcomes. Conclusion Conclusion: taking into account the potential limitations of PSP, our results suggest that ustekinumab may be as effective as proactive IFX with some benefits compared to vedolizumab and conventional IFX.