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Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy

Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy STUDY Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy Patients Ineligible vs Eligible for Randomized Controlled Trials Ignacio Garcia-Doval, MScEpid, PhD; Gregorio Carretero, PhD; Francisco Vanaclocha, PhD; Carlos Ferrandiz, PhD; Esteban Daude ´ n, PhD; Jose-Luis Sa ´ nchez-Carazo, MD; Merce ´ Alsina, MD; Enrique Herrera-Ceballos, PhD; Francisco-Jose´Go ´ mez-Garcı ´a, MD; Marta Ferra ´ n, MD; Jose-Luis Lo ´ pez-Estebaranz, MD; Jose-Manuel Hernanz, MD; Isabel Belincho ´ n-Romero, PhD; Jaime Vilar-Alejo, MD; Raquel Rivera, MD; Jose-Manuel Carrascosa, PhD; Cristina Carazo, MD Objective: To describe the use of systemic therapy for Main Outcome Measures: Serious adverse events as psoriasis (biologic and nonbiologic [classic] drugs) in pa- defined by the International Conference on Harmoniza- tients not adequately represented in randomized con- tion were evaluated. trolled trials (RCTs) and the risk of serious adverse events Results: In all, 29.8% of patients receiving systemic (SAEs) in these patients. therapy for psoriasis would not have been eligible for RCTs. These individuals had an increased risk of SAEs Design: A registry inception cohort was used. (incidence rate ratio, 2.7; 95% CI, 1.5-4.7). Patients ex- posed to biologics had an adjusted increased risk of SAEs Setting: Thirteen dermatology departments in http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Dermatology American Medical Association

Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy

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References (20)

Publisher
American Medical Association
Copyright
Copyright 2012 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6068
eISSN
2168-6084
DOI
10.1001/archdermatol.2011.2768
pmid
22508869
Publisher site
See Article on Publisher Site

Abstract

STUDY Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy Patients Ineligible vs Eligible for Randomized Controlled Trials Ignacio Garcia-Doval, MScEpid, PhD; Gregorio Carretero, PhD; Francisco Vanaclocha, PhD; Carlos Ferrandiz, PhD; Esteban Daude ´ n, PhD; Jose-Luis Sa ´ nchez-Carazo, MD; Merce ´ Alsina, MD; Enrique Herrera-Ceballos, PhD; Francisco-Jose´Go ´ mez-Garcı ´a, MD; Marta Ferra ´ n, MD; Jose-Luis Lo ´ pez-Estebaranz, MD; Jose-Manuel Hernanz, MD; Isabel Belincho ´ n-Romero, PhD; Jaime Vilar-Alejo, MD; Raquel Rivera, MD; Jose-Manuel Carrascosa, PhD; Cristina Carazo, MD Objective: To describe the use of systemic therapy for Main Outcome Measures: Serious adverse events as psoriasis (biologic and nonbiologic [classic] drugs) in pa- defined by the International Conference on Harmoniza- tients not adequately represented in randomized con- tion were evaluated. trolled trials (RCTs) and the risk of serious adverse events Results: In all, 29.8% of patients receiving systemic (SAEs) in these patients. therapy for psoriasis would not have been eligible for RCTs. These individuals had an increased risk of SAEs Design: A registry inception cohort was used. (incidence rate ratio, 2.7; 95% CI, 1.5-4.7). Patients ex- posed to biologics had an adjusted increased risk of SAEs Setting: Thirteen dermatology departments in

Journal

JAMA Dermatology – American Medical Association

Published: Apr 1, 2012

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