Efficacy Of Vedolizumab In Ulcerative Colitis Research Articles

REAL-WORLD SAFETY AND EFFICACY OF USTEKINUMAB AND VEDOLIZUMAB IN PEDIATRIC PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Abstract CONTEXT/PURPOSE Ustekinumab and vedolizumab are approved biologicals to treat adults with inflammatory bowel disease (IBD) but currently administered off-label for children. Aims: (1) assess safety and adverse events during treatment with ustekinumab or vedolizumab in pediatric IBD and (2) assess steroid free clinical remission and mucosal healing at 6 months and 1 year. METHODS Retrospective chart review of pediatric patients (<22 years) with IBD treated at an academic hospital and two affiliated practices. Inclusion: Patients with IBD who received either ustekinumab or vedolizumab between January 2015 to June 2022 with minimum of 6 months follow up. Clinical remission assessed by Pediatric Ulcerative Colitis Activity Index (PUCAI) < 10 and short Pediatric Crohn’s Disease Activity Index (shPCDAI) <15, and mucosal healing by fecal calprotectin <250 mcg/gram. RESULTS Fifty-eight patients received vedolizumab and 55 patients received ustekinumab. Patients with ulcerative colitis (UC) or IBD unclassified (IBDU) on vedolizumab were more likely to be in remission at 6 months (58% vs. 42%, p = 0.3, Table 1) and significantly higher at achieving 1-year steroid free remission (64% vs. 27%, p = 0.019) compared to ustekinumab. Over two thirds of biologic naïve and about half of biologic exposed patients who received vedolizumab achieved 1-year steroid free remission (78% vs. 58%, Figure 1). All patients who received ustekinumab were biologic exposed. In Crohn’s disease (CD), no significant difference was seen in children receiving vedolizumab compared to ustekinumab at 6 months remission (57% vs. 63%, p = 0.7) or 1-year steroid free remission (70% vs. 70%, p >0.9). All biologic naïve patients and half of biologic exposed patients who received vedolizumab achieved 1 year steroid free remission. Both bionaive and two thirds of biologic exposed patients who received ustekinumab achieved 1-year steroid free remission (100% vs. 67%). When comparing vedolizumab and ustekinumab, no significant difference was observed in 6 month remission (73% vs. 59%, p = 0.2) and 1-year steroid free remission based on calprotectin (61% vs. 66%, p = 0.7). Similar to clinical remission rates, biologic naïve patients tended to have higher remission rates based on calprotectin. Five patients each had minor adverse events with ustekinumab and vedolizumab, and 20 were hospitalized mostly for IBD flare. CONCLUSION Both biologicals were safe and effective in achieving clinical remission at 6 months and 1 year. They were more effective when used in bionaive patients, although numbers were very low for ustekinumab. The superior efficacy of vedolizumab in UC and IBDU at 1-year may be attributed to larger cohort of bionaive patients. Larger multicenter prospective studies are needed to validate these findings regarding efficacy and safety of vedolizumab and ustekinumab in pediatric IBD. Table 1 Remission on Vedolizumab and Ustekinumab Figure 1 Remission on Vedolizumab vs. Ustekinumab Stratified by Biologic Exposure

P421 Treatment optimization with vedolizumab in treatment-refractory patients with ulcerative colitis and Crohn’s disease – a real-world two-center cohort study

Abstract Background Real-world data about treatment optimization of vedolizumab in ulcerative colitis (UC) and Crohn’s disease (CD) are scarce. Therefore, we aimed to investigate the influence of administration of a supplementary dose of vedolizumab at week ten on short and long-term outcomes. Methods A retrospective two-center cohort study was conducted between November 2014 and November 2019. The primary outcomes were clinical remission (CR) at weeks 14, 30, 52, and 104 and Sustained CR (SCR) defined as CR at week 14 through week 52. Results The study included 182 patients (UC: 97, CD: 85), all previously exposed to at least one biological therapy. As shown in Table 1, patients with CD receiving or not receiving the additional dosing at week ten were comparable in terms of disease activity at weeks 0 and 6, while patients with UC receiving the dosing at week 10 experienced higher disease activity at week 0 but not week 6. The overall efficacy of vedolizumab in UC and CD stratified according to treatment with the optional dosing at week ten is summarized in Figures 1 and 2, demonstrating no statistically significant difference among patients receiving or not receiving vedolizumab at week 10. Furthermore, the optional dosing of vedolizumab at week 10 (odds ratio (OR)=0.23 (95%CI 0.03-1.17), and OR=0.68 (95%CI 0.22-2.04)), was not associated with CR at week 52 among patients with UC and CD, respectively. Conclusion Vedolizumab is effective in achieving short and long-term CR and SCR in patients with treatment-refractory UC and CD. This study emphasizes that supplementary dosing at week 10 did not improve long-term outcomes.

Factors influencing the outcome of vedolizumab treatment: Real-life data with objective outcome measurements.

BackgroundVedolizumab (VDZ), a humanised monoclonal antibody against a4ß7‐integrin, has shown efficacy in inflammatory bowel disease (IBD). It is of importance to assess the mid‐to long‐term efficacy of VDZ using real‐life data.ObjectiveOur study aimed to determine the efficacy of VDZ in patients with IBD with and without prior exposure to anti‐tumour necrosis factor (TNF) treatments in a real‐life setting. Furthermore, we investigated confounding factors influencing the remission to VDZ.MethodsPatients participating in the Swiss IBD Cohort Study were included in this study. Remission was defined as calprotectin less than 200 mg/kg stool and/or mucosal healing determined by endoscopy. End points were determined between Months 4 and 8 (T1) and between Months 12 and 16 (T2) after VDZ induction.ResultsRemission was reported in 50.5% (110/218) of patients in T1 (48.7% Crohn's disease [CD] and 52.5% ulcerative colitis [UC]) and 46.8% (102/218) in T2 (47% CD and 46.5% UC). In UC patients, a significantly higher remission rate was achieved in T2 among anti‐TNF‐naive patients (57.7%) compared to anti‐TNF‐experienced patients (34.7%; p = 0.02; odds ratio = 0.39, 95% confidence interval: 0.17–0.87). In patients with CD, no difference could be seen in either evaluation interval. Multivariable analysis showed that disease duration significantly influenced remission rates among UC patients. A late response to VDZ therapy with an achievement of remission in T2 was seen in a fifth of all patients (CD: 21.7%, UC: 20.8%). VDZ treatment was stopped in a third of all patients (31.8%) due to nonresponse, adverse events or aggravation of extra‐intestinal manifestations.ConclusionIn a real‐life national cohort setting, VDZ induced remission in more than half of IBD patients. Previous treatment with anti‐TNF agents was associated with a significant lower efficacy of VDZ in UC but not in CD patients.