Timing of Vedolizumab During Active Infection

Vedolizumab should not be initiated during an active infection; treatment must be delayed until the infection is fully resolved and cleared. 1

Key Management Principles

All active infections must be treated and resolved before starting vedolizumab therapy. 1 This is a fundamental safety principle for all immunomodulating biologics, including vedolizumab.
Physical examination, laboratory tests, and imaging performed at baseline (before starting immunotherapy) serve as the reference for identifying any clinical, biological, or imaging abnormalities that could indicate infection. 1
Patients with a history of chronic infections require particularly careful evaluation, though vedolizumab's gut-selective mechanism may offer theoretical safety advantages over systemic immunosuppressants. 1

Patients with a history of autoimmune disorders can receive vedolizumab, but treatment decisions must weigh individual potential benefits against expected risks. 1 The presence of autoimmune history alone does not contraindicate vedolizumab.
Patients with organ-specific autoimmunity (such as the inflammatory bowel disease being treated) may be monitored closely, but vedolizumab has demonstrated safety even in immunocompromised patients. 2
One case report documented successful vedolizumab use in a child with X-linked agammaglobulinemia and Crohn's disease, with no infections observed over 18 months of treatment. 2

Vedolizumab has a favorable infection safety profile compared to other biologics. In the GEMINI I trial, serious infections were not more common with vedolizumab than with placebo. 1, 3
In ulcerative colitis specifically, vedolizumab is associated with a 32% lower risk of serious infections compared to anti-TNF agents (HR 0.68,95% CI 0.50-0.93). 4
However, in patients with prior anti-TNF exposure, there is an increased risk of serious infection (HR 1.99,95% CI 1.16-3.42). 1 This underscores the importance of infection clearance before initiating therapy, particularly in anti-TNF-experienced patients.

Autoimmune hemolytic anemia (AIHA) is a rare but documented adverse event with vedolizumab. 5 One case report described AIHA developing after vedolizumab initiation in a patient with ulcerative colitis, requiring rituximab for treatment.
If the patient has active hemolysis, the etiology must be determined before vedolizumab initiation. If AIHA is present, vedolizumab should be avoided or used with extreme caution, as it may potentially worsen autoimmune hemolysis. 5
Baseline hemoglobin, reticulocyte count, LDH, haptoglobin, and direct Coombs test should be obtained to establish a reference for monitoring. 5

Identify and treat active infection completely - delay vedolizumab until infection is fully resolved 1
Screen for chronic infections (HBV, HCV, HIV, tuberculosis) - these require specialist consultation but do not absolutely contraindicate vedolizumab 1
Evaluate hemolysis - if active AIHA is present, consider alternative biologics; if hemolysis is from another cause, address before initiating vedolizumab 5
Assess autoimmune disease activity - ensure any concurrent autoimmune conditions are stable or adequately controlled 1
Once infection is cleared and hemolysis is controlled, vedolizumab can be safely initiated at standard dosing (300 mg IV at weeks 0,2, and 6) 1

Do not start vedolizumab with any active infection present, even if the infection seems minor or the patient's inflammatory bowel disease is severe. 1 The risk of worsening infection outweighs the benefit of earlier IBD treatment.
Do not assume vedolizumab is contraindicated in patients with autoimmune history - the evidence supports its use with appropriate monitoring. 1, 2
Do not overlook hemolysis workup - anemia in IBD patients may be multifactorial, and AIHA must be ruled out before attributing it solely to IBD activity or iron deficiency. 5