Dose escalation of vedolizumab in inflammatory bowel disease patients with secondary loss of response

GastroHep ◽  
2021 ◽  
Vol 3 (2) ◽  
pp. 62-62
Author(s):  
Her Hsin Tsai
Keyword(s):  
Inflammatory Bowel Disease ◽  
Dose Escalation ◽  
Bowel Disease ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel

P082 ANTI-TNF EFFICACY AFTER PRIMARY VEDOLIZUMAB FAILURE IN PEDIATRIC INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S71-S72
Author(s):  
Michael Dolinger ◽  
Priya Rolfes ◽  
Becky Phan ◽  
Stephanie Pan ◽  
Marla Dubinsky
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Abstract Background Vedolizumab (VDZ) is less effective in Inflammatory Bowel Disease (IBD) when used in anti-Tumor Necrosis Factor (TNF) failures as compared to anti-TNF naïve patients. However, the outcomes of sequencing anti-TNF after VDZ failure remain unknown. We report on the effectiveness and safety of anti-TNF as a second-line biologic after VDZ failure in pediatric IBD patients. Methods Data was collected as part of an ongoing pediatric IBD observational treatment registry and included demographics, disease behavior, location, disease activity (Harvey Bradshaw index (HBI) for Crohn’s disease (CD) or partial Mayo score (pMS) for ulcerative colitis (UC) and IBD-unspecified (IBD-U)), adverse events, treatment and surgical history. Primary outcome was steroid-free clinical remission at last follow up. Secondary outcomes were CRP normalization and adverse events including infusion reactions, infections, hospitalizations, and IBD related surgeries. Descriptive statistics summarized the data (median [interquartile range (IQR)]) and univariate analyses tested associations. Results A total of 21 children and young adults (6 CD:14 UC:1 IBD-U; 19/21 colonic only disease) were treated with VDZ for a median [IQR] duration of 25 [11–59] weeks. VDZ was discontinued due to primary non-response (57%), secondary loss of response (38%), or an adverse event (5%). Nineteen (90%) patients were induced with infliximab (IFX), 1 with adalimumab, and 1 with golimumab and were followed for a median of 100 [35–148] weeks after anti-TNF induction (Table 1). Fifteen (71%) patients remained on anti-TNF therapy at last follow up for a median duration of 53 [34–112] weeks. All 15 patients achieved steroid-free clinical remission, and 9 (60%) patients also had a normal CRP (Figure 1). Remission rates were numerically higher in UC/IBD-U vs. CD (80% vs. 50% P = 0.27). All 6 (28%) patients (3 CD and 3 UC) who discontinued anti-TNF therapy after a median duration of 15 [7–24] weeks initially had a primary non-response to VDZ. Three patents had a primary non-response to anti-TNF, 2 had a secondary loss of response, and 1 had an anaphylactic infusion reaction. No serious adverse events, hospitalizations or serious infections attributable to anti-TNF therapy occurred. Conclusions Our results suggest that anti-TNF therapy is efficacious and safe after primary failure with VDZ in pediatric IBD patients and this was particularly so in patients with colonic disease location, regardless of IBD classification.

P045 Do Levels Matter? Maintaining Anti-TNF Class After Secondary Loss of Response to Adalimumab in Inflammatory Bowel Disease

2019 ◽  
Vol 114 (1) ◽  
pp. S12-S12
Author(s):  
Bauer Christina ◽  
Younis Adam ◽  
Long Millie ◽  
Herfarth Hans ◽  
Barnes Edward
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel

scholarly journals P632 Vedolizumab dose escalation in patients with inflammatory bowel disease experiencing loss of response: A systematic review and meta-analysis of real-world evidence

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S524-S525
Author(s):  
D Varghese ◽  
D Patel ◽  
S Martin ◽  
M Luo ◽  
L Ursos ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Random Effects ◽  
Dose Escalation ◽  
Real World ◽  
Bowel Disease ◽  
Response Rate ◽  
Meta Analysis ◽  
Open Label ◽  
Loss Of Response ◽  
Inflammatory Bowel

Abstract Background Moderately to severely active inflammatory bowel disease (IBD), featured as Crohn’s disease (CD) and ulcerative colitis (UC) collectively, is commonly treated with biologic therapies. A proportion of patients experience loss of response (LOR) over time. The approved dose of vedolizumab (VDZ), 300 mg every 8-week (Q8W), is known to be safe and effective in the treatment of UC and CD. In an open-label long-term safety study (GEMINI LTS), patients who experienced LOR during maintenance benefitted from dose escalation to an every 4-week (Q4W) regimen. Clinical response and remission were regained in 41% and 28% respectively in UC patients (N=32) and 47% and 32% respectively in CD patients (N=57) through 52 weeks of escalated dosing. The aim of this study was to conduct a meta-analysis of existing real-world evidences to evaluate the effectiveness of VDZ dose escalation to Q4W in IBD patients experiencing LOR to Q8W dosing. Methods A systematic literature review was performed using PubMed and Embase databases for articles and conference abstracts from January 2014 through January 2019 for real-world studies reporting clinical outcomes to VDZ dose-escalation among adult patients with UC or CD. Relevant congresses were also screened for accepted abstracts through June 2019. Summary estimates for the proportion of regained response and remission were synthesised under a random effect model (given considerable heterogeneity as measured by I2 statistic) using the DerSimonian-Laird approach. Results The search yielded a total of 842 citations from the databases and 12 citations from hand searching. Of these, 5 full-text articles and 1 abstract were included in the meta-analysis. The 6 study cohorts included a total of 297 patients with IBD. The random-effects pooled regained response rate from the 6 studies was 56.5% (95% confidence interval [CI], 44.9%–67.5%) within 52 weeks (figure). Subgroup analysis showed a regained response rate of 62.7% (95% CI,52.8%–71.6%) when measured within 30 weeks vs. 50.2% (95% CI, 38.3%–62.2%) when measured after 30 weeks. Of the 6 studies, 2 reported remission rates that were included in the pooled analysis among 203 patients experiencing LOR. The random-effects pooled estimate of recaptured remission was 42.4% (95% CI, 25.1%–61.8%) within 52 weeks. Conclusion More than half of IBD patients who experienced LOR during maintenance phase after initial response to VDZ Q8W dosing regained response on the escalated Q4W regimen within 52 weeks. These findings and the data from the open-label clinical trial support the benefits of VDZ dose escalation among patients experiencing LOR to Q8W dosing.

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