title: Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR).
abstract: BACKGROUND
  Safety surveillance is needed for biologic therapies for psoriasis.
  
  
  OBJECTIVE
  To assess the risk of adverse events of special interest (AEoSIs) with ustekinumab and other psoriasis treatments in a real-world setting using 2014 Psoriasis Longitudinal Assessment and Registry (PSOLAR) data. AEoSIs included malignancy (excluding nonmelanoma skin cancer), major adverse cardiovascular events (MACE), serious infection, and all-cause mortality.
  
  
  METHODS
  Cumulative rates of AEoSIs/100 patient-years (PY) are reported for ustekinumab, infliximab, other biologics (mostly adalimumab/etanercept), and non-biologics based on pre-specified analyses using attribution rules biased against ustekinumab. Risk factors for AEoSIs, including treatments, were determined using multivariate statistical analysis.
  
  
  RESULTS
  A total of 12,093 patients (40,388 PY) were enrolled in PSOLAR. Overall incidence rates were 0.68/100PY for malignancy, 0.33/100PY for MACE, 1.60/100PY for serious infection, and 0.46/100PY for mortality. Unadjusted rates of serious infection for infliximab (2.91/100PY) and other biologics (1.91/100PY) were numerically higher compared with ustekinumab (0.93/100PY). Exposure to the combined group of biologics other than ustekinumab was significantly associated with serious infection (hazard ratio=1.96, P<.001). None of the biologics was associated with increased risk of malignancy, MACE, or mortality.
  
  
  CONCLUSIONS
  Observational data have inherent biases.
  
  
  CONCLUSIONS
  Analysis of 2014 PSOLAR data identified no increased risk of malignancy, MACE, serious infection, or mortality with ustekinumab.
authors.forename: Kim
authors.initials: K
authors.lastname: Papp
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: Luigi
authors.initials: L
authors.lastname: Naldi
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Vincent
authors.initials: V
authors.lastname: Ho
authors.forename: Kavitha
authors.initials: K
authors.lastname: Goyal
authors.forename: Steven
authors.initials: S
authors.lastname: Fakharzadeh
authors.forename: Marc
authors.initials: M
authors.lastname: Chevrier
authors.forename: Stephen
authors.initials: S
authors.lastname: Calabro
authors.forename: Wayne
authors.initials: W
authors.lastname: Langholff
authors.forename: Gerald
authors.initials: G
authors.lastname: Krueger
mesh_terms: D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011565:Psoriasis / Q000188:drug therapy* / Q000401:mortality; D012042:Registries; D012878:Skin Neoplasms / Q000139:chemically induced / Q000453:epidemiology; D000069549:Ustekinumab / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D003879:Dermatologic Agents; D000069549:Ustekinumab