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 Anti-TNF agents are used to treat a variety of autoimmune conditions, including psoriasis. Paradoxically, new onset of psoriasis or psoriasiform skin lesions (PPSL) can occur in patients treated with these agents. We report a case series of patients featuring PPSL induced by infliximab (IFX) with pharmacokinetic and fecal calprotectin (Fc) correlation. Methods One hundred and thirty-five consecutive patients with Inflammatory Bowel Disease under proactive therapeutic drug monitoring (TDM) with IFX were evaluated for PPSL. Results Fifteen patients (11.1%) developed PPSL, 12 females (80%), with median age at diagnosis of 52.0 years (38-63). At the onset of PPSL, 6 patients were on 10 mg/kg every 6 weeks, 5 patients on 5 mg/kg every 8 weeks, 2 patients on 10 mg/kg every 4 weeks, 1 patient on 10 mg/kg every 8 weeks, and 1 patent on 5 mg/kg every 6 weeks. In patients with PPSL, IFX trough levels (IFXTL) significantly increased before and after the advent of PPSL: 6.18 µg/mL (3.28-9.91) vs 9.20 µg/mL (5.89-13.91), P= 0.001. At the time of PPSL, all but 2 patients were in Fc remission (< 250 µg/g), median 41 µg/g (30-103). Seven patients improved with topic therapy and 8 patients (53.3%) discontinued IFX (3 switched to ustekinumab) all of which improved. Compared with the overall cohort, IFXTL were higher in patients with PPSL: 7.27 µg/mL (4.02-10.86) vs 6.26 µg/mL (3.37-9.14), P= 0.023. In multivariate regression analysis, female gender [OR 4.84 95%CI (1.23-19.00), P= 0.024], and any IFXTL≥ 10 µg/mL [OR 5.66 95%CI (1.40-22.87), P= 0.015] were independent predictors of developing PPSL. Conclusion Most patients with PPSL presented high IFXTL and low Fc. We hypothesize that high concentrations of IFX in the setting of deep remission may signal aberrant pro-inflammatory pathways potentially responsible for PPSL.
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.
Background Fecal calprotectin (Fc) is an adequate surrogate marker for endoscopic activity in inflammatory bowel disease. The timing of Fc remission may have prognostic implications in patients under biologic therapy. Methods Using a prospectively maintained database we followed 135 patients under a proactive therapeutic drug monitoring (pTDM) protocol aiming at an Infliximab trough level (IFXTL) between 5-10 µg/mL with sequential measurements of Fc. We evaluated the rates of early (at week 14) and late (after week 14) Fc remission (<250 µg/g) and associated clinical outcomes at 2-years of follow up. Results 77 patients (57.0%) reached early Fc remission and 30 patients (22.2%) reached late Fc remission. Patients with late Fc remission presented higher Fc at baseline (1708.5 μg/g [681-3483] vs 803 μg/g [339-1477], P=0.006) and lower IFXTL at week 14 (2.71 µg/mL [1.24-6.30] vs 6.59 µg/mL [3.41-10.63], P=0.001) than patients with early Fc remission. However, by the end of follow-up, IFXTL were similar in both groups: 7.94 µg/mL (4.79-11.25) vs 8.54 µg/mL (6.49-11.07), P=0.514. In patients without early Fc remission, week 14 IFXTL did not differ between those with and without late Fc remission (2.71 µg/mL [1.24-6.30] vs 3.47 µg/mL [0.945-6.94], P=0.957), but significantly increased in late responders by the end of follow-up: 8.54 µg/mL (6.49-11.07) vs 4.37 µg/mL (1.77-7.49), P=0.002. Patients with early and late Fc remission presented similar rates of clinical remission (88.3% vs 83.0%, P=0.493), steroid-free clinical remission (79.1% vs 92.9% P=0.239), lower rates of IFX discontinuation (14.3% vs 16.7%, P=0.756), hospitalization (11.7% vs 13.3%, P=0.815), and surgery (1.3% vs 3.3%, P=0.485). Conclusion The magnitude of Fc at baseline and IFXTL at week 14 significantly influence the timing of Fc remission. The use of PTDM results in similar pharmacokinetics and clinical outcomes in both groups.
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