Predicting Response to Vedolizumab in Inflammatory Bowel Disease

Abstract

Vedolizumab is known to be safe, well-tolerated, and effective. However, as personalization becomes an increasingly important aspect of IBD care and in lieu of guidelines to inform clinicians on positioning of biologics, there is a need to reliably predict response to inform patient preferences and shared decision-making. Recent data from clinical trials and real-world evidence have elucidated predictors of clinical and endoscopic response while providing the framework to establish predictive models. Current models are able to predict that those patients with less severe disease, without prior biologic exposure and who demonstrate early response to VDZ have the highest rates of durable clinical and endoscopic response and remission. When incorporating these models into clinical practice, clinicians will be able to identify those patients who are likely to respond before drug initiation as well as early non-responders and response latency after initiation of vedolizumab. In a shift toward personalization of medicine in IBD, the ability of predictive models for vedolizumab to aid pre-biologic and early management will inform both clinician and patient. Ideally this will provide both a personalized and more cost-effective approach, though further studies in cost-analysis in this framework are needed. Though current models are comprehensive of existing data, future research on microbial and translational biomarkers will be additive and necessary to provide full personalization of treatment.

Various Forms of Tuberculosis in Patients with Inflammatory Bowel Diseases Treated with Biological Agents

“…This mode of action does not result in systemic immunosuppression and, consequently, should not increase the risk of cancer or opportunistic infections, including TB. Those findings were confirmed by Ng et al [ 25 ] where TB among study participants was observed rarely and reactivation of HBV and HCV infections was not seen [ 26 ]. Results of the subsequent study by Colombel et al [ 27 ] involving 2,830 patients with nonspecific IBD demonstrated occurrence of TB, sepsis, and Clostridium infections in up to 0.6% patients.…”

“…Results of the subsequent study by Colombel et al [ 27 ] involving 2,830 patients with nonspecific IBD demonstrated occurrence of TB, sepsis, and Clostridium infections in up to 0.6% patients. Results from numerous studies indicate that vedolizumab is efficient in inducing and sustaining remission and is considered to be safe and well tolerated [ 23 , 24 , 26 , 28 ]. Studies involving patients with UC suggest that vedolizumab is effective, especially as a second-line treatment after previous therapy with TNF α inhibitors [ 28 , 29 ].…”

Clinical experiences and predictors of success of treatment with vedolizumab in IBD patients: a cohort study

“…To the contrary, clinical characteristics of patients are easy to collect and may directly help to estimate outcomes. Thus, using clinical parameters for such purposes has been previously suggested [ 22 ].…”

Respiratory Tract Infections in Inflammatory Bowel Disease Patients Taking Vedolizumab: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Effectiveness of the drug was confirmed by many real-world observational studies (Chaparro et al, 2018;Christensen et al, 2018;Lenti et al, 2018;Plevris et al, 2019;Scarozza et al, 2020). It was also reported that patients with less severe disease and naïve to tumor necrosis factor (TNF) blockers are more likely to respond to vedolizumab (Dulai et al, 2016;Amiot et al, 2017;Favale et al, 2019;Hupe et al, 2020;Meserve and Dulai, 2020). Overall, the above studies showed also the drug is well-tolerated with an acceptable safety profile (Colombel et al, 2017).…”