Abstract:Background
Combined therapy with vedolizumab and corticosteroids may improve clinical response or remission in Crohn’s disease. The aim of this study is to assess efficacy and safety/tolerability of vedolizumab plus stable doses of corticosteroids at baseline during induction therapy in moderately to severely active Crohn’s disease.
Methods
A post hoc exploratory analysis was performed on data from GEMINI 2 (NCT00783692) and … Show more
Background and aims
There are limited comparative data for infliximab and vedolizumab in inflammatory bowel disease patients.
Methods
We conducted a systematic review and meta-analysis to compare the efficacy and safety of infliximab and vedolizumab in adult patients with moderate-to-severe Crohn’s disease or ulcerative colitis.
Results
We identified six eligible Crohn’s disease and seven eligible ulcerative colitis trials that randomised over 1900 participants per disease cohort to infliximab or vedolizumab. In the Crohn’s disease and ulcerative colitis cohorts, infliximab yielded better efficacy than vedolizumab for all analysed outcomes (CDAI-70, CDAI-100 responses, and clinical remission for Crohn’s disease and clinical response and clinical remission for ulcerative colitis) during the induction phase, with non-overlapping 95% confidence intervals. In the maintenance phase, similar proportions of infliximab- or vedolizumab-treated patients achieved clinical response, clinical remission, or mucosal healing in both Crohn’s disease and ulcerative colitis. For the safety outcomes, rates of adverse events, serious adverse events, and discontinuations due to adverse events were similar in infliximab- and vedolizumab-treated patients in both diseases. The infection rate was higher in infliximab for Crohn’s disease and higher in vedolizumab when treating patients with ulcerative colitis. There was no difference between the treatments in the proportions of patients who reported serious infections in both indications.
Conclusions
Indirect comparison of infliximab and vedolizumab trials in adult patients with moderate-to severe Crohn’s disease or ulcerative colitis demonstrated that infliximab has better efficacy in the induction phase and comparable efficacy during the maintenance phase and overall safety profile compared to vedolizumab.
Background and aims
There are limited comparative data for infliximab and vedolizumab in inflammatory bowel disease patients.
Methods
We conducted a systematic review and meta-analysis to compare the efficacy and safety of infliximab and vedolizumab in adult patients with moderate-to-severe Crohn’s disease or ulcerative colitis.
Results
We identified six eligible Crohn’s disease and seven eligible ulcerative colitis trials that randomised over 1900 participants per disease cohort to infliximab or vedolizumab. In the Crohn’s disease and ulcerative colitis cohorts, infliximab yielded better efficacy than vedolizumab for all analysed outcomes (CDAI-70, CDAI-100 responses, and clinical remission for Crohn’s disease and clinical response and clinical remission for ulcerative colitis) during the induction phase, with non-overlapping 95% confidence intervals. In the maintenance phase, similar proportions of infliximab- or vedolizumab-treated patients achieved clinical response, clinical remission, or mucosal healing in both Crohn’s disease and ulcerative colitis. For the safety outcomes, rates of adverse events, serious adverse events, and discontinuations due to adverse events were similar in infliximab- and vedolizumab-treated patients in both diseases. The infection rate was higher in infliximab for Crohn’s disease and higher in vedolizumab when treating patients with ulcerative colitis. There was no difference between the treatments in the proportions of patients who reported serious infections in both indications.
Conclusions
Indirect comparison of infliximab and vedolizumab trials in adult patients with moderate-to severe Crohn’s disease or ulcerative colitis demonstrated that infliximab has better efficacy in the induction phase and comparable efficacy during the maintenance phase and overall safety profile compared to vedolizumab.
“…At weeks 6 and 10, patients who were randomized to receive vedolizumab had 15.2% (week 6) and 26.6% (week 10) clinical remission, while patients who received placebo had 12.1% (week 6) and 12.1% (week 10) clinical remission (p = 0.433, p = 0.001, respectively). 27 …”
Several biologic therapies have been approved for enteric diseases. We evaluate each biologic’s role based on their mechanism of action in treating these conditions. This review examines data on efficacy and safety, as well as considerations for using these therapies in clinical practice in inflammatory bowel diseases, enteric infections—specifically
Clostridioides difficile
colitis—and potentially in the increasingly prevalent disorder of eosinophilic esophagitis. When choosing an appropriate therapy, it is important to assess patient severity, as most biologics are approved for those with moderate to severe disease activity. With many years of data from clinical trials and real-world experience, these therapies have been shown to improve outcomes overall in enteric diseases, contributing to more options for our patients.
“…Pivotal studies in UC (GEMINI-1) and CD (GEMINI 2) found 1/895 (0.11%) death due to acute coronary syndrome and 1/1115 (0.09%) death due to myocarditis in a male patient with a history of DVT [ 34 , 35 ]. Neither the post hoc analysis of GEMINI 2 and GEMINI 3 trials, nor long-term trials of GEMINI LTS, found cases of CVEs or VTE even when VDZ was associated with CSs [ 36 , 37 , 38 ]. A recent VARSITY trial, which compared VDZ with adalimumab, recorded only one case out of 383 (0.26%) patients treated with VDZ with superficial thrombophlebitis [ 39 ].…”
Patients with inflammatory bowel disease (IBD) have an increased risk of venous thromboembolism (VTE). Alongside the traditional acquired and genetic risk factors for VTE, patients with IBD have pathogenic and clinical peculiarities that are responsible for the increased number of thromboembolic events occurring during their life. A relevant role in modifying this risk in a pro or antithrombotic manner is played by pharmacological therapies and surgery. The availability of several biological agents and small-molecule drugs with different mechanisms of action allows us to also tailor the treatment based on the individual prothrombotic risk to reduce the occurrence of VTE. Available review articles did not provide sufficient and updated knowledge on this topic. Therefore, we assessed the role of each single treatment, including surgery, in modifying the risk of VTE in patients with IBD to provide physicians with recommendations to minimize VTE occurrence. We found that the use of steroids, particularly if prolonged, increased VTE risk, whereas the use of infliximab seemed to reduce such risk. The data relating to the hypothesized prothrombotic risk of tofacitinib were insufficient to draw definitive conclusions. Moreover, surgery has an increased prothrombotic risk. Therefore, implementing measures to prevent VTE, not only with pharmacological prophylaxis but also by reducing patient- and surgery-specific risk factors, is necessary. Our findings confirm the importance of the knowledge of the effect of each single drug or surgery on the overall VTE risk in patients with IBD, even if further data, particularly regarding newer drugs, are needed.
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