Literature DB >> 29036254

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

Robert Bissonnette, Francisco Kerdel, Luigi Naldi, Kim Papp, Claudia Galindo, Wayne Langholff, K L Tang, Philippe Szapary, Steven Fakharzadeh, Bhaskar Srivastava, Kavitha Goyal, Alice B Gottlieb.   

Abstract

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>.

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Year:  2017        PMID: 29036254

Source DB:  PubMed          Journal:  J Drugs Dermatol        ISSN: 1545-9616            Impact factor:   2.114


  11 in total

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Review 4.  Infliximab and biosimilar infliximab in psoriasis: efficacy, loss of efficacy, and adverse events.

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6.  The potential impact of systemic anti-inflammatory therapies in psoriasis on major adverse cardiovascular events: a Korean nationwide cohort study.

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Review 8.  Cardiovascular Safety of Biologics Targeting Interleukin (IL)-12 and/or IL-23: What Does the Evidence Say?

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Review 9.  Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR.

Authors:  Robert Bissonnette; Alice B Gottlieb; Richard G Langley; Craig L Leonardi; Kim A Papp; David M Pariser; Jonathan Uy; Kim Parnell Lafferty; Wayne Langholff; Steven Fakharzadeh; Jesse A Berlin; Emily S Brouwer; Andrew J Greenspan; Bruce E Strober
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Review 10.  Safety of selective IL-23p19 inhibitors for the treatment of psoriasis.

Authors:  J J Crowley; R B Warren; J C Cather
Journal:  J Eur Acad Dermatol Venereol       Date:  2019-06-27       Impact factor: 6.166

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