Vedolizumab ( Entyvio ) is a gut-selective antibody to alpha4beta7 integrin for the treatment of ulcerative colitis and Crohn's disease. An integrated summary of the safety of Vedolizumab was reported.
Safety data ( May 2009–June 2013 ) from six trials of Vedolizumab were integrated. Adverse events were evaluated in patients who received greater than or equal to 1 dose of Vedolizumab or placebo and were reported as exposure-adjusted incidence rates as the number of patients experiencing the event per 100 person-years ( PYs ) of exposure.
Predictors of serious infection were assessed using a Cox proportional hazards model.
In total, 2830 patients had 4811 PYs of Vedolizumab exposure ( median exposure range, 1–1977 days ).
No increased risk of any infection or serious infection was associated with Vedolizumab exposure. Serious clostridial infections, sepsis and tuberculosis were reported infrequently ( less than or equal to 0.6% of patients ).
No cases of progressive multifocal leucoencephalopathy were observed.
Independent risk factors for serious infection in ulcerative colitis were prior failure of a tumour necrosis factor alpha antagonist ( hazard ratio, HR=1.99; 95% CIs 1.16 to 3.42; p=0.0122 ) and narcotic analgesic use ( HR=2.68; 95% CI 1.57 to 4.58; p=0.0003 ), and in Crohn's disease were younger age ( HR=0.97; 95% CI 0.95 to 0.98; p less than 0.0001 ), corticosteroid ( HR=1.88; 95% CI 1.35 to 2.63; p=0.0002 ) or narcotic analgesic use ( HR=2.72; 95% CI 1.90 to 3.89; p less than 0.0001 ).
Investigator-defined infusion-related reactions were reported for less than or equal to 5% of patients in each study.
Eighteen Vedolizumab-exposed patients ( less than 1% ) were diagnosed with a malignancy.
In conclusion, Vedolizumab has a favourable safety profile with low incidence rates of serious infections, infusion-related reactions and malignancies over an extended treatment period. ( Xagena )
Source: Gut, 2016