Evaluation of Risk of Major Adverse Cardiovascular Events With Biologic Therapy in Patients With Psoriasis

J Drugs Dermatol. 2017 Oct 1;16(10):1002-1013.


Background: Psoriasis is associated with increased risk of major adverse cardiovascular events (MACE).

Objectives: Compare MACE risk with biologics vs topical/phototherapy use.

Methods: Psoriasis Longitudinal Assessment Registry (PSOLAR) is an international psoriasis registry of patients eligible to receive biologic/systemic treatments prospectively. MACE is defined as myocardial infarction, stroke, or cardiovascular death. Biologic cohorts, including tumor necrosis factor-alpha (TNF-α) inhibitors (ie, adalimumab, etanercept, and infliximab) and ustekinumab, combined and by class, were compared with a topical/phototherapy cohort. Incidence rates of MACE per 100-patient-years (100PY) with 95% confidence intervals (95% CI) are reported. Multivariate analyses were performed to evaluate the effect of treatment on the risk of MACE adjusting for confounders.

Results: Analyses included 7550 patients: 6767 in the combined biologics cohort (3949 and 2818 in the TNF-α inhibitors and ustekinumab cohorts, respectively) and 783 in the topical/phototherapy cohort. Mean duration of exposure was approximately 2.8 years (combined biologics) and 4.1 years (topical/phototherapy). A total of 52 MACE were reported; MACE incidence rates were 0.22/100PY (95% CI: 0.16, 0.30) for the combined biologics cohort (TNF-α inhibitors [0.20/100PY (0.12, 0.31)] and ustekinumab [0.24/100PY (0.15, 0.37]) and 0.34/100PY (0.17, 0.61) for the topical/phototherapy cohort. For the combined biologics (hazard ratio=0.92; 95% CI [0.426, 1.988]), TNF-α inhibitor (0.85 [0.373, 1.928]), and ustekinumab (1.03[0.440, 2.402]) cohorts, treatment was not associated with increased risk of MACE versus the topical/phototherapy cohort.

Conclusion: Based on data accumulated to date in PSOLAR, treatment with biologics did not have an impact on the risk of MACE in patients with moderate-to-severe psoriasis. <p><em>J Drugs Dermatol. 2017;16 (10):1002-1013.</em></p>.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Biological Products / administration & dosage
  • Biological Products / therapeutic use*
  • Biological Therapy / methods
  • Cardiovascular Diseases / epidemiology*
  • Cardiovascular Diseases / etiology
  • Cohort Studies
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Incidence
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Phototherapy / methods
  • Psoriasis / complications
  • Psoriasis / pathology
  • Psoriasis / therapy*
  • Registries
  • Severity of Illness Index
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors


  • Biological Products
  • Dermatologic Agents
  • Tumor Necrosis Factor-alpha