Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR)
July 2015 | Volume 14 | Issue 7 | Original Article | 706 | Copyright © July 2015
Kim Papp MD PhD,a Alice B. Gottlieb MD PhD,b Luigi Naldi MD,c David Pariser MD,d Vincent Ho MD,
e Kavitha Goyal MD,f Steven Fakharzadeh MD PhD,f Marc Chevrier MD PhD,g Stephen Calabro MS,f
Wayne Langholff PhD,g and Gerald Krueger MDh
aProbity Research, Waterloo, Canada
bTufts Medical Center, Boston, MA
cCentro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED), Azienda Ospedaliera Papa Giovanni XXIII,
Bergamo, Italy
dEastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA
eUniversity of British Columbia, Vancouver, British Columbia, Canada
fJanssen Scientific Affairs, LLC, Horsham, PA
gJanssen Research & Development, LLC, Horsham, PA
hUniversity of Utah Health Sciences Center, Salt Lake City, UT
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.
J Drugs Dermatol. 2015;14(7):706-714.
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INTRODUCTION
Psoriasis is a chronic, immune-mediated, inflammatory disorder without precise origin, for which patients are treated with conventional systemic agents and, more recently,
biologic agents. The safety of biologic agents has been studied for the treatment of psoriasis for up to 5 years of follow-up in long-term clinical trials.1-4 However, potential safety signals
may be recognized in a real-world setting, such as observational
studies, that can supplement results from randomized controlled trials in larger, more inclusive patient populations over longer periods of time.5,6
The Psoriasis Longitudinal Assessment and Registry (PSOLAR) is an ongoing, disease-based, observational study in which patients
eligible for, or receiving, conventional systemic and biologic agents for the treatment of psoriasis are followed prospectively.7 PSOLAR contributes to the postmarketing commitments for the sponsor (Janssen Scientific Affairs, LLC, Horsham, PA) to monitor safety with use of ustekinumab and infliximab, which are indicated
for the treatment of plaque psoriasis. Observational studies like PSOLAR offer the opportunity to contextualize safety outcomes by collecting data across treatment groups in a real-world setting.
