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Journal of the American Academy of Dermatology
Volume 77, n° 5
page 845 (novembre 2017)
Doi : 10.1016/j.jaad.2017.07.013
accepted : 13 July 2017
Original Articles

Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry
 

David Fiorentino, MD, PhD a, , Vincent Ho, MD b, Mark G. Lebwohl, MD c, Luiz Leite, MD d, Lori Hopkins, PharmD e, Claudia Galindo, MD e, Kavitha Goyal, MD e, Wayne Langholff, PhD e, Steven Fakharzadeh, MD, PhD e, Bhaskar Srivastava, MD, PhD e, Richard G. Langley, MD f
a Stanford University School of Medicine, Palo Alto, California 
b University of British Columbia, Vancouver, British Columbia, Canada 
c Icahn School of Medicine at Mount Sinai, New York, New York 
d Clinica Laser de Belém, Lisbon, Portugal 
e Janssen Scientific Affairs, LLC, Horsham, Pennsylvania 
f Dalhousie University, Halifax, Nova Scotia, Canada 

Reprint requests: David Fiorentino, MD, PhD, Department of Dermatology, Stanford University School of Medicine, 450 Broadway, C-234, Palo Alto, CA 94036.Department of Dermatology, Stanford University School of Medicine450 Broadway, C-234Palo AltoCA94036
Abstract
Background

The effect of systemic therapy on malignancy risk among patients with psoriasis is not fully understood.

Objective

Evaluate the impact of systemic treatment on malignancy risk among patients with psoriasis in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

Methods

Nested case-control analyses were performed among patients with no history of malignancy. Cases were defined as first malignancy (other than nonmelanoma skin cancer) in the Psoriasis Longitudinal Assessment and Registry, and controls were matched by age, sex, geographic region, and time on registry. Study therapies included methotrexate, ustekinumab, and tumor necrosis factor-α (TNF-α) inhibitors. Exposure was defined as 1 or more doses of study therapy within 12 months of malignancy onset and further stratified by duration of therapy. Multivariate conditional logistic regression, adjusted for potential confounders, was used to estimate odds ratios of malignancies associated with therapy.

Results

Among 12,090 patients, 252 malignancy cases were identified and 1008 controls were matched. Treatment with methotrexate or ustekinumab for more than 0 months to less than 3 months, 3 months to less than 12 months, or 12 months or longer was not associated with increased malignancy risk versus no exposure. Longer-term (≥12 months) (odds ratio, 1.54; 95% confidence interval, 1.10-2.15; P  = .01), but not shorter-term treatment, with a TNF-α inhibitor was associated with increased malignancy risk.

Limitations

Cases and controls could belong to 1 or more therapy categories.

Conclusions

Long-term (≥12 months) treatment with a TNF-α inhibitor, but not methotrexate and ustekinumab, may increase risk for malignancy in patients with psoriasis.

The full text of this article is available in PDF format.

Key words : biologic, conventional systemic, malignancy, methotrexate, psoriasis, PSOLAR, tumor necrosis factor-α inhibitors, TNF-α inhibitors, ustekinumab

Abbreviations used : CI, NMSC, OR, PSOLAR, PY, SOC, TNF-α



 Supported by Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
 Disclosure: Dr Fiorentino has received honoraria as an advisory board member for Janssen and as a consultant for Idera, Janssen, Pfizer, Samumed, and 23andMe, and he has received research support as a principal investigator for Janssen and Idera. Dr Ho has received honoraria as an advisory board member for Abbvie, Eli Lilly, Janssen, and Novartis. Dr Lebwohl is an employee of the Mount Sinai Medical Center, which receives research funds from AbbVie, Amgen, Boehringer Ingleheim, Celgene, Eli Lilly, Janssen Research and Development, Kadmon, Leo Pharma, Novartis, Pfizer, and ViDac. Dr Leite has received honoraria as a speaker for Janssen and Pfizer and as a principal investigator from Novartis. Dr Langley has received honoraria as a principal investigator, advisory board member, or speaker for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, Leo, Lilly, Merck, Novartis, and Pfizer. Drs Hopkins, Galindo, Goyal, Langholff, Fakharzadeh, and Srivastava are employed by Janssen Scientific Affairs, LLC and own stock in Johnson & Johnson, of which Janssen is a subsidiary.



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