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.
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 (<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<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<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<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 (<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< 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.
Background Crohn’s Disease (CD) is a chronic inflammatory disease primarily affecting the bowel. In the pre-biological era, approximately 40–50% of patients would undergo surgery within the first 2 decades after diagnosis, with a risk of postoperative recurrence up to 50% at 10 years. Although post-operative prophylaxis is recommended to prevent clinical and endoscopic recurrence, little is known about the factors associated with surgical recurrence. Methods Single-center, retrospective study including 992 patients with CD. Demographic and clinical data were retrieved from patients’ medical charts. Patients with 1 or more surgeries were selected for analysis, excluding perianal disease surgeries. Thiopurines and biologics were considered as prophylaxis for surgical recurrence only if initiated within the first year after surgery. A logistic regression analysis was performed to evaluate potential predictors of surgery recurrence. Results Three hundred and nine patients (31.1%) required at least one surgery during follow-up. Two hundred and twenty-four patients (72.5%) underwent a single surgery and 85 (27.5%) required two or more interventions. Patients with surgical recurrence were younger [31 (23–36) vs 34 years (24–44), p=0.009], and had lower rates of prophylaxis with thiopurines (23.5% vs 37.5%, p=0.013), and anti-tumor necrosis factor (TNF) agents (8.2% vs 22.3%, p=0.002) compared with patients without surgical recurrence. Multivariate analysis identified stricturing and penetrating phenotype as risk factor for surgical recurrence (OR 2.292 95%CI [1.500–3.502], p<0.001]). Likewise, older age (OR 0.949 95%CI [0.94–0.996], p=0.034), and prophylaxis with anti-TNFs (OR 0.309 95% [0.126–0.754], p=0.01) were protective factors against surgical recurrence. Twenty-five patients (29.4%) developed a second surgical recurrence. Patients with more than one surgical recurrence had lower utilization of thiopurines (16% vs 45%, p=0.009) and anti-TNFs (0% vs 26.7%, p=0.002). Conclusion Our findings suggest that postoperative prophylaxis with immunosuppressants, especially anti-TNFs, significantly reduces the risk of surgical recurrence. Postoperative prophylaxis should be implemented in high-risk patients, especially younger patients and those with a non-inflammatory phenotype.
Background A large body of evidence demonstrates a significant correlation between week 14 infliximab trough levels (IFXTL) and several clinical outcomes. In patients with low IFXTL at week 14, proactive therapeutic drug monitoring (TDM) may potentially improve clinical results. Methods Retrospective study including 181 patients (63.5% with Crohn’s disease) under proactive TDM. IFXTL were measured at week 14 and every 2 infusions using a drug sensitive assay (Theradiag®, Lisa Tracker) with treatment proactively escalated to an IFXTL 5–10 ug/ml. We compared the clinical outcomes between patients with low (<5 ug/ml) and adequate IFXTL at week 14, in respect to clinical remission, fecal calprotectin (Fc) remission, C-reactive protein (CRP) remission, hospitalization, treatment discontinuation, and surgery up to 1 year of follow-up. Results Ninety-one patients (50.3%) had low IFXTL at week 14. These patients presented lower rates of clinical remission (69.2% vs 82.2%, P=0.031), Fc remission (41.9% vs 73.4%, P<0.001), and CRP remission (60.7% vs 72.7%, P= 0.061) at week 14 of treatment. Likewise, worse outcomes were also shown by the end of the study, with lower rates of clinical remission (64.8% vs 87.8%, P<0.001), and Fc remission (58.9% vs 77.9%, P=0.005), and higher rates of hospitalization (17.6% vs 6.7%, P=0.021), surgery (5.5% vs 0%, P=0.030), treatment discontinuation (36.3% vs 17.8%, P=0.004), and any unfavorable outcome (42.9% vs 21.1%, P=0.001). Following proactive treatment escalation, fifty-nine patients (64.8%) were successful in increasing IFXTL ≥5 ug/ml within subsequent infusions. These patients presented higher rates of clinical remission (79.7% vs 37.5%, P<0.001), and lower rates of treatment discontinuation (20.3% vs 65.6%, P<0.001), surgery (1.7% vs 12.5, P=0.05), and any unfavorable outcome (28.8% vs 68.8%, P<0.001), with a non-significant trend for higher rates of Fc remission (63.8% vs 50%, P=0.147). These patients also presented similar outcomes compared to patients with adequate week 14 IFXTL in respect to clinical remission (P=0.134), Fc remission (P=0.049), hospitalization (P=0.131), surgery (P=0.396), treatment discontinuation (P=0.426), and any unfavorable outcome (P=0.189). Conclusion IFXTL significantly influence early and long-term treatment outcomes. In patients with inadequate IFXTL at week 14, proactive TDM was associated with improved clinical outcomes.
surgery (= local hemostasis). In TOURNIQUET, a high arm tourniquet was used. Pain score, patient satisfaction, quality of endoscopic surgical procedure (visualization), need of rescue tourniquet in WALANT, efficiency, rate of complications were noted. Results Demographic data are presented in table 1. WALANT significantly reduced pain score and the use of sedation. Even if the quality of visualization was high in both groups, it was better in TOURNIQUET (table 2). No rescue tourniquet was necessary in WALANT. The rate of hematoma 15 days post-surgery was higher in TOURNIQUET. No other adverse event was observed. Conclusions Addition of WALANT to distal blocks is adapted for CTR. WALANT improves the comfort of the patient and the quality of anesthesia and provides good surgery conditions.
Background Proactive therapeutic drug monitoring (pTDM) may potentially improve disease control and treatment outcomes in inflammatory bowel disease. Methods Using a prospectively maintained database we compared 135 patients following a pTDM protocol aiming at an Infliximab trough level (IFXTL) between 5-10 µg/mL with sequential measurements of Fc, with 108 patients from a retrospective group under conventional management (noTDM). We evaluated the rates of Fc remission (<250 µg/g), and other clinical outcomes at 2-years 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 follow-up (8.10 vs 5.03 μg/mL, P=0.001). Fc remission associated with higher rates of clinical remission (85.8% vs 56.8% P<0.001), steroid-free clinical remission (86.9% vs 50.0% P<0.001), and lower rates of IFX discontinuation (8.8% vs 36.8%, P<0.001), and hospitalization (13.5% vs 33.7%, P<0.001) with a non-significant trend for surgery (6.1% vs 12.6%, P=0.101). Conclusion PTDM was more effective than conventional management in inducing Fc remission which associated with improved clinical outcomes.
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