Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

J Drugs Dermatol. 2015 Jul;14(7):706-14.


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.

Limitations: Observational data have inherent biases.

Conclusion: Analysis of 2014 PSOLAR data identified no increased risk of malignancy, MACE, serious infection, or mortality with ustekinumab.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Psoriasis / drug therapy*
  • Psoriasis / mortality
  • Registries
  • Skin Neoplasms / chemically induced
  • Skin Neoplasms / epidemiology
  • Ustekinumab / adverse effects
  • Ustekinumab / therapeutic use*


  • Dermatologic Agents
  • Ustekinumab