Sa1723 - Comparative Effectiveness of Vedolizumab and Tumor Necrosis Factor-Antagonist Therapy in Crohn's Disease: A Multicenter Consortium Propensity Score-Matched Analysis

Bohm, Matthew; Sagi, Sashivar; Fischer, Monika; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Aniwan, Satimai; Meserve, Joseph; Weiss, Aaron; Kochhar, Gursimran; Shashi, Preeti; Faleck, David; Winters, Adam C.; Chablaney, Shreya; Koliani-Pace, Jenna L.; Boland, Brigid S.; Singh, Siddharth; Hirten, Robert; Shmidt, Eugenia; Lasch, Karen; Luo, Michelle; Hudesman, David; Chang, Shannon; Lukin, Dana J.; Simfukwe, Keith; Swaminath, Arun; Gupta, Nitin; Siegel, Corey A.; Kane, Sunanda V.; Loftus, Edward V.; Sands, Bruce E.; Sandborn, William J.; Colombel, Jean Fréd́eric; Shen, Bo; Dulai, Parambir S.

doi:10.1016/s0016-5085(18)31547-6

Cited by 4 publications

(9 citation statements)

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“…Using propensity score matching, 269 patients with active Crohn’s disease in the VICTORY consortium were matched 1:1 with anti-TNF treated patients. At 1 year remission was observed in vedolizumab and anti-TNF treated patients in 38% and 34% respectively, HR 1.27 (95% CI 0.91 to 1.27), steroid-free remission in 26% and 18%, HR 1.75 (95% CI 0.90 to 3.43), endoscopic healing in 50% and 41% respectively, HR 1.67 (95% CI 1.13 to 2.47) 505. Side effects of vedolizumab are discussed in the Section 5.2.5 Drug management: vedolizumab and ustekinumab.…”

Section: Crohn’s Diseasementioning

confidence: 99%

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

Lamb

Kennedy

Raine

et al. 2019

Gut

1,485

1,648

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Ulcerative colitis and Crohn’s disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn’s and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn’s disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn’s disease, including patients, their families and friends.

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Section: Crohn’s Diseasementioning

confidence: 99%

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

Lamb

Kennedy

Raine

et al. 2019

Gut

1,485

1,648

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“…Network meta‐analysis in UC suggested similar efficacy of infliximab and VDZ, however VDZ had a superior safety profile in some but not in all analyses . In a multicentre propensity‐adjusted analysis, in CD, there was no significant difference in clinical remission rates at 12 months in the VDZ (38%) compared to anti‐TNF (34%), while VDZ‐treated patients had higher rates of endoscopic healing . In contrast, among 334 UC patients (167 on VDZ), VDZ‐treated patients had higher rates of clinical remission (54% vs 37%) and endoscopic healing (50% vs 42%) at 1 year .…”

Section: Discussionmentioning

confidence: 97%

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Adar

Faleck

Sasidharan

et al. 2019

Aliment Pharmacol Ther

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Background:The older patient group with inflammatory bowel diseases (IBD) is particularly vulnerable to consequences of disease and therapy-related side effects but little is known about the best treatment options in this population. Aim:To compare safety and efficacy of tumor necrosis factor α antagonist (anti-TNF) or vedolizumab (VDZ) in patients with IBD >60 years of age.Methods: This retrospective study included patients with Crohn's disease (CD) or ulcerative colitis (UC) initiating anti-TNF or VDZ therapy ≥60 years of age at three study sites. We examined occurrence of infection or malignancy within 1 year after therapy as our primary outcome. Our efficacy outcomes included clinical remission at 3, 6 and 12 months. Multivariable logistic regression models adjusting for relevant confounders estimated odds ratios (OR) and 95% confidence intervals. Results:The study included 131 anti-TNF and 103 VDZ initiated patients (age range 60-88 years). Approximately half had CD. At 1 year, there were no significant differences in safety profile between the two therapeutic classes. Infections were observed in 20% of anti-TNF-treated and 17% of VDZ-treated patients (P = 0.54).Pneumonia was the most common infection in both groups. While more anti-TNFtreated CD patients were in remission at 3 months compared to VDZ (OR 2.82, 95% CI 1.18-6.76), this difference was not maintained at 6 and 12 months suggesting similar efficacy of both classes. Conclusions:Both anti-TNF and VDZ therapy were similarly effective and safe in elderly IBD patients.

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“…Due to the presence of competing events, we applied our approach under the competing risks models to estimate the treatment effect of Vedolizumab. In Bohm et al, 11 the propensity score for each subject i, denoted PS i , was calculated using the R package "twang" 20 based on pretreatment variables, including prior TNF-antagonist exposure and number of prior TNF-antagonists exposed, disease extent, history of fistulizing disease, prior bowel surgery, disease phenotype, clinical disease severity, CD related hospitalization within the preceding 1-year, baseline steroid dependency or refractoriness, concomitant steroid use, or concomitant immunomodulator use.…”

Section: Datamentioning

confidence: 97%

“…As described earlier, given the observed data, U follows Bernoulli(̃i) as in (3) wherẽi is calculated based on the current parameter valuẽ. So for any function h(u i ) in (10) and (11)…”

Section: E-stepmentioning

confidence: 99%

“…Therefore, surgery presents a competing risk to clinical remission, in that surgery prevents the event of achieving clinical remission. In Lukin et al 10 and Bohm et al 11 the authors considered propensity score methods with IPW as the primary approach to account for the observed covariates. However, it is possible that there might be confounders not captured by the observed covariates.…”

Section: Introductionmentioning

confidence: 99%

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Sensitivity analysis of treatment effect to unmeasured confounding in observational studies with survival and competing risks outcomes

Huang

Dulai

2020

Statistics in Medicine

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No unmeasured confounding is often assumed in estimating treatment effects in observational data, whether using classical regression models or approaches such as propensity scores and inverse probability weighting. However, in many such studies collection of confounders cannot possibly be exhaustive in practice, and it is crucial to examine the extent to which the resulting estimate is sensitive to the unmeasured confounders. We consider this problem for survival and competing risks data. Due to the complexity of models for such data, we adapt the simulated potential confounder approach of Carnegie et al (2016), which provides a general tool for sensitivity analysis due to unmeasured confounding. More specifically, we specify one sensitivity parameter to quantify the association between an unmeasured confounder and the exposure or treatment received, and another set of parameters to quantify the association between the confounder and the time-to-event outcomes. By varying the magnitudes of the sensitivity parameters, we estimate the treatment effect of interest using the stochastic expectation-maximization (EM) and the EM algorithms. We demonstrate the performance of our methods on simulated data, and apply them to a comparative effectiveness study in inflammatory bowel disease. An R package "survSens" is available on CRAN that implements the proposed methodology.

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Sa1723 - Comparative Effectiveness of Vedolizumab and Tumor Necrosis Factor-Antagonist Therapy in Crohn's Disease: A Multicenter Consortium Propensity Score-Matched Analysis

Cited by 4 publications

References 0 publications

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Sensitivity analysis of treatment effect to unmeasured confounding in observational studies with survival and competing risks outcomes

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