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Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) Errata

June 2020 | Volume 19 | Issue 6 | Editorials | 571 | Copyright © June 2020


Published online June 11, 2020

Kim A. Papp , Wayne Langholff

Abstract
Erratum for article "Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)." Retrieved from https://jddonline.com/articles/dermatology/S1545961615P0706X

J Drugs Dermatol 2015;14(7):706-714  J Drugs Dermatol 2020;19:e32-e34
Dear Editor,

Due to a programming error, the rates of non-fatal major adverse cardiovascular events (MACE) in our article entitled ‘Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR),’ are incorrect.¹ Inadvertently, the Sponsor (Janssen Scientific Affairs, LLC, Horsham, PA, United States) excluded relevant preferred terms (PTs) from the ‘cardiac disorders’ system organ class from the Medical Dictionary for Regulatory Activities (MedDRA). While the individual PTs of ‘myocardial infarction’ and ‘cerebrovascular accident’ were included in the data set, other relevant PTs (e.g., ‘acute coronary syndrome’, ‘acute myocardial infarction’, ‘embolic stroke’, ‘thrombotic stroke’) were omitted unintentionally. As soon as the oversight was identified, the search strategy was corrected to capture all PTs included in the Standardized MedDRA Queries of ‘myocardial infarction’ and ‘ischemic central nervous system vascular conditions’. Analyses of fatal cardiovascular events and other adverse events of interest reported in the original publication (i.e., serious infections and malignancies) were not affected by this omission. Inclusion of the additional PTs increased the unadjusted cumulative incidence rates of non-fatal MACE per 100 patient-years of exposure across all PSOLAR cohorts (Table 3); however, the revised multivariate Cox proportionate model indicated no important changes (Table 4). The results of the revised analyses confirm the conclusion of the original publication, which was that treatment with biologics did not increase the risk of MACE in patients with psoriasis enrolled in PSOLAR.

Sincerely,
Kim A. Papp, MD, PhD, Probity Research, Waterloo, Ontario, Canada; and Wayne Langholff, PhD, Janssen Research & Development, LLC, Horsham, PA, United States.

Reference:
1. Papp K, Gottlieb AB, Naldi L, et al. Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Drugs Dermatol 2015;14(7):706-714.