Based on one trial, SC injection of vedolizumab is more effective than placebo in achieving clinical remission in patients with moderately to severely active CD. The benefits related to other outcomes assessed in the trial are uncertain based on failure to detect a statistically significant difference between vedolizumab SC and placebo for the secondary outcome of enhanced clinical response, which was ranked higher than other outcomes in the stepwise analysis procedure. The frequency of AEs was similar between placebo and vedolizumab SC, after 52 weeks of treatment.

Based on one sponsor-submitted review of ITCs, ▬▬▬▬▬ due to limitations in its precisions and sources of heterogeneity in the NMA that decrease confidence in the results.

Results from an ongoing, open-label, long-term study suggest that ▬▬▬▬▬

▬▬▬▬▬. However, these results are of low certainty because of the significant limitations associated with the longer-term study.

At the submitted price based on the recommended dose of 108 mg every 2 weeks, vedolizumab SC has an annual cost of $21,458 per patient in maintenance therapy. This results in cost-neutrality compared to vedolizumab IV on an annual basis; however, information on the comparative efficacy and safety of vedolizumab SC is uncertain and the exclusion of induction therapy costs underestimate total treatment costs versus other comparators.