Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis

Jashin J Wu; Bruce E Strober; Peter R Hansen; Ole Ahlehoff; Alexander Egeberg; Abrar A Qureshi; Debbie Robertson; Hernan Valdez; Huaming Tan; Robert Wolk

doi:10.1016/j.jaad.2016.06.012

Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis

Jashin J Wu, Bruce E Strober, Peter R Hansen, Ole Ahlehoff, Alexander Egeberg, Abrar A Qureshi, Debbie Robertson, Hernan Valdez, Huaming Tan, Robert Wolk

25 Citations (Scopus)

Abstract

BACKGROUND: Psoriasis is a systemic inflammatory condition that is associated with a higher risk of cardiovascular (CV) disease. Tofacitinib is being investigated as a treatment for psoriasis.

OBJECTIVE: We sought to evaluate the effects of tofacitinib on CV risk factors and major adverse CV events (MACEs) in patients with plaque psoriasis.

METHODS: Changes in select CV risk factors and the incidence rate (IR) of MACEs were evaluated in patients who were treated with tofacitinib.

RESULTS: Tofacitinib treatment was associated with small, dose-dependent increases in total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol, while the total/HDL cholesterol ratio was unchanged. There were no changes in blood pressure and glycated hemoglobin levels; C-reactive protein levels decreased. The IRs of a MACE were low and similar for both tofacitinib doses. Among 3623 subjects treated with tofacitinib, the total patient-years of exposure was 5204, with a median follow-up of 527 days, and the IR of MACEs was 0.37 (95% confidence interval, 0.22-0.57) patients with events per 100 patient-years.

LIMITATIONS: There was relatively short follow-up time for patients who had MACEs.

CONCLUSIONS: While treatment with tofacitinib is associated with a small increase in cholesterol levels, the total/HDL cholesterol ratio does not change, there are no unfavorable changes in several CV risk factors, and the incidence of MACEs is low.

Original language	English
Journal	Journal of the American Academy of Dermatology
Volume	75
Issue number	5
Pages (from-to)	897-905
Number of pages	9
ISSN	0190-9622
DOIs	https://doi.org/10.1016/j.jaad.2016.06.012
Publication status	Published - 1 Nov 2016

Keywords

Adult
Blood Pressure
C-Reactive Protein
Cardiovascular Diseases
Cholesterol
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Comorbidity
Dyslipidemias
Female
Hemoglobin A, Glycosylated
Humans
Male
Metabolic Syndrome X
Middle Aged
Piperidines
Protein Kinase Inhibitors
Psoriasis
Pyrimidines
Pyrroles
Risk Factors
Treatment Outcome
Triglycerides
Journal Article

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jaad.2016.06.012

Cite this

Wu, J. J., Strober, B. E., Hansen, P. R., Ahlehoff, O., Egeberg, A., Qureshi, A. A., Robertson, D., Valdez, H., Tan, H., & Wolk, R. (2016). Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis. Journal of the American Academy of Dermatology, 75(5), 897-905. https://doi.org/10.1016/j.jaad.2016.06.012

Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis. / Wu, Jashin J; Strober, Bruce E; Hansen, Peter R et al.
In: Journal of the American Academy of Dermatology, Vol. 75, No. 5, 01.11.2016, p. 897-905.

Research output: Contribution to journal › Journal article › Research › peer-review

Wu, JJ, Strober, BE, Hansen, PR, Ahlehoff, O, Egeberg, A, Qureshi, AA, Robertson, D, Valdez, H, Tan, H & Wolk, R 2016, 'Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis', Journal of the American Academy of Dermatology, vol. 75, no. 5, pp. 897-905. https://doi.org/10.1016/j.jaad.2016.06.012

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title = "Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis",

abstract = "BACKGROUND: Psoriasis is a systemic inflammatory condition that is associated with a higher risk of cardiovascular (CV) disease. Tofacitinib is being investigated as a treatment for psoriasis.OBJECTIVE: We sought to evaluate the effects of tofacitinib on CV risk factors and major adverse CV events (MACEs) in patients with plaque psoriasis.METHODS: Changes in select CV risk factors and the incidence rate (IR) of MACEs were evaluated in patients who were treated with tofacitinib.RESULTS: Tofacitinib treatment was associated with small, dose-dependent increases in total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol, while the total/HDL cholesterol ratio was unchanged. There were no changes in blood pressure and glycated hemoglobin levels; C-reactive protein levels decreased. The IRs of a MACE were low and similar for both tofacitinib doses. Among 3623 subjects treated with tofacitinib, the total patient-years of exposure was 5204, with a median follow-up of 527 days, and the IR of MACEs was 0.37 (95% confidence interval, 0.22-0.57) patients with events per 100 patient-years.LIMITATIONS: There was relatively short follow-up time for patients who had MACEs.CONCLUSIONS: While treatment with tofacitinib is associated with a small increase in cholesterol levels, the total/HDL cholesterol ratio does not change, there are no unfavorable changes in several CV risk factors, and the incidence of MACEs is low.",

keywords = "Adult, Blood Pressure, C-Reactive Protein, Cardiovascular Diseases, Cholesterol, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Comorbidity, Dyslipidemias, Female, Hemoglobin A, Glycosylated, Humans, Male, Metabolic Syndrome X, Middle Aged, Piperidines, Protein Kinase Inhibitors, Psoriasis, Pyrimidines, Pyrroles, Risk Factors, Treatment Outcome, Triglycerides, Journal Article",

author = "Wu, {Jashin J} and Strober, {Bruce E} and Hansen, {Peter R} and Ole Ahlehoff and Alexander Egeberg and Qureshi, {Abrar A} and Debbie Robertson and Hernan Valdez and Huaming Tan and Robert Wolk",

year = "2016",

month = nov,

day = "1",

doi = "10.1016/j.jaad.2016.06.012",

language = "English",

volume = "75",

pages = "897--905",

journal = "Journal of the American Academy of Dermatology",

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T1 - Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis

AU - Wu, Jashin J

AU - Strober, Bruce E

AU - Hansen, Peter R

AU - Ahlehoff, Ole

AU - Egeberg, Alexander

AU - Qureshi, Abrar A

AU - Robertson, Debbie

AU - Valdez, Hernan

AU - Tan, Huaming

AU - Wolk, Robert

PY - 2016/11/1

Y1 - 2016/11/1

N2 - BACKGROUND: Psoriasis is a systemic inflammatory condition that is associated with a higher risk of cardiovascular (CV) disease. Tofacitinib is being investigated as a treatment for psoriasis.OBJECTIVE: We sought to evaluate the effects of tofacitinib on CV risk factors and major adverse CV events (MACEs) in patients with plaque psoriasis.METHODS: Changes in select CV risk factors and the incidence rate (IR) of MACEs were evaluated in patients who were treated with tofacitinib.RESULTS: Tofacitinib treatment was associated with small, dose-dependent increases in total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol, while the total/HDL cholesterol ratio was unchanged. There were no changes in blood pressure and glycated hemoglobin levels; C-reactive protein levels decreased. The IRs of a MACE were low and similar for both tofacitinib doses. Among 3623 subjects treated with tofacitinib, the total patient-years of exposure was 5204, with a median follow-up of 527 days, and the IR of MACEs was 0.37 (95% confidence interval, 0.22-0.57) patients with events per 100 patient-years.LIMITATIONS: There was relatively short follow-up time for patients who had MACEs.CONCLUSIONS: While treatment with tofacitinib is associated with a small increase in cholesterol levels, the total/HDL cholesterol ratio does not change, there are no unfavorable changes in several CV risk factors, and the incidence of MACEs is low.

AB - BACKGROUND: Psoriasis is a systemic inflammatory condition that is associated with a higher risk of cardiovascular (CV) disease. Tofacitinib is being investigated as a treatment for psoriasis.OBJECTIVE: We sought to evaluate the effects of tofacitinib on CV risk factors and major adverse CV events (MACEs) in patients with plaque psoriasis.METHODS: Changes in select CV risk factors and the incidence rate (IR) of MACEs were evaluated in patients who were treated with tofacitinib.RESULTS: Tofacitinib treatment was associated with small, dose-dependent increases in total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol, while the total/HDL cholesterol ratio was unchanged. There were no changes in blood pressure and glycated hemoglobin levels; C-reactive protein levels decreased. The IRs of a MACE were low and similar for both tofacitinib doses. Among 3623 subjects treated with tofacitinib, the total patient-years of exposure was 5204, with a median follow-up of 527 days, and the IR of MACEs was 0.37 (95% confidence interval, 0.22-0.57) patients with events per 100 patient-years.LIMITATIONS: There was relatively short follow-up time for patients who had MACEs.CONCLUSIONS: While treatment with tofacitinib is associated with a small increase in cholesterol levels, the total/HDL cholesterol ratio does not change, there are no unfavorable changes in several CV risk factors, and the incidence of MACEs is low.

KW - Adult

KW - Blood Pressure

KW - C-Reactive Protein

KW - Cardiovascular Diseases

KW - Cholesterol

KW - Clinical Trials, Phase II as Topic

KW - Clinical Trials, Phase III as Topic

KW - Comorbidity

KW - Dyslipidemias

KW - Female

KW - Hemoglobin A, Glycosylated

KW - Humans

KW - Male

KW - Metabolic Syndrome X

KW - Middle Aged

KW - Piperidines

KW - Protein Kinase Inhibitors

KW - Psoriasis

KW - Pyrimidines

KW - Pyrroles

KW - Risk Factors

KW - Treatment Outcome

KW - Triglycerides

KW - Journal Article

U2 - 10.1016/j.jaad.2016.06.012

DO - 10.1016/j.jaad.2016.06.012

M3 - Journal article

C2 - 27498960

SN - 0190-9622

VL - 75

SP - 897

EP - 905

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

IS - 5

ER -

Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis

Abstract

Keywords

UN SDGs

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