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Stelara (Ustekinumab) & Serious Infection

Basic Details
Status
Complete
Last Updated
Thursday, October 3, 2024
Original Posting Date
Health Outcome(s)
serious infection (Crohn’s disease)
serious infection (ulcerative colitis)
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
Yes
Analytic Code Link(s) (1)
Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease: An Inverse Probability of Treatment Weighting Analysis
Result(s) (4)
Ustekinumab Dispensing Patterns: A Descriptive Analysis Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease or Ulcerative Colitis: A Descriptive Analysis Ustekinumab and Comparator Treatment Utilization and Pneumonia Outcomes in Patients with Crohn's Disease or Ulcerative Colitis: An Updated Descriptive Analysis Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease: An Inverse Probability of Treatment Weighting Analysis
Regulatory Link(s) (1)
FDA Approval Package Materials