Dear Editor,
Some of the cardiovascular data in our article entitled ‘Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): Experience with infliximab and other systemic and biologic therapies,’ needs to be corrected.1 Specifically, when analyzing safety data related to major adverse cardiovascular events (MACE) from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), the Sponsor (Janssen Scientific Affairs, LLC, Horsham, PA, United States) unintentionally omitted some relevant Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) for non-fatal MACE. Specifically, the only MedDRA PTs included in the data set were the individuals PTs of ‘myocardial infarction’ and ‘cerebrovascular accident’; other relevant PTs (e.g., ‘acute coronary syndrome’, ‘acute myocardial infarction’, ‘embolic stroke’, ‘thrombotic stroke’) were omitted inadvertently. However, once the error was recognized, 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’. This omission did not affect the analyses of fatal cardiovascular events or other adverse events of interest reported in the original publication (i.e., serious infections and malignancies). Inclusion of the additional PTs increased the unadjusted cumulative incidence rates of non-fatal MACE across all PSOLAR cohorts (Table 2), though no meaningful changes were identified based on the multivariate Cox model analyses (Table 3). As reported in the original publication, treatment with biologics did not increase the risk of MACE in patients with psoriasis.
Sincerely,
Alice B. Gottlieb, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, NY, United States; and Wayne Langholff, PhD, Janssen Research & Development, LLC, Horsham, PA, United States.
Reference:
1. Gottlieb AB, Kalb RE, Langley RG, et al. Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR) : Experience with infliximab and other systemic and biologic therapies. J Drugs Dermatol 2014;13(12):1441-1448.
Some of the cardiovascular data in our article entitled ‘Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): Experience with infliximab and other systemic and biologic therapies,’ needs to be corrected.1 Specifically, when analyzing safety data related to major adverse cardiovascular events (MACE) from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), the Sponsor (Janssen Scientific Affairs, LLC, Horsham, PA, United States) unintentionally omitted some relevant Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) for non-fatal MACE. Specifically, the only MedDRA PTs included in the data set were the individuals PTs of ‘myocardial infarction’ and ‘cerebrovascular accident’; other relevant PTs (e.g., ‘acute coronary syndrome’, ‘acute myocardial infarction’, ‘embolic stroke’, ‘thrombotic stroke’) were omitted inadvertently. However, once the error was recognized, 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’. This omission did not affect the analyses of fatal cardiovascular events or other adverse events of interest reported in the original publication (i.e., serious infections and malignancies). Inclusion of the additional PTs increased the unadjusted cumulative incidence rates of non-fatal MACE across all PSOLAR cohorts (Table 2), though no meaningful changes were identified based on the multivariate Cox model analyses (Table 3). As reported in the original publication, treatment with biologics did not increase the risk of MACE in patients with psoriasis.
Sincerely,
Alice B. Gottlieb, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, NY, United States; and Wayne Langholff, PhD, Janssen Research & Development, LLC, Horsham, PA, United States.
Reference:
1. Gottlieb AB, Kalb RE, Langley RG, et al. Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR) : Experience with infliximab and other systemic and biologic therapies. J Drugs Dermatol 2014;13(12):1441-1448.
