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.

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.

• Authors: Kim Papp, Alice B Gottlieb, Luigi Naldi, David Pariser, Vincent Ho, Kavitha Goyal, Steven Fakharzadeh, Marc Chevrier, Stephen Calabro, Wayne Langholff, Gerald Krueger
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 14 Issue 7 Pg. 706-14 (Jul 2015) ISSN: 1545-9616 [Print] United States
• PMID: 26151787 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Dermatologic Agents
• Ustekinumab

Topics

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