Why disguise adverse events?




Poster session 4 Saturday: Evidence implementation and evaluation


Saturday 16 September 2017 - 12:30 to 14:00


All authors in correct order:

Azevedo DC1, Rodrigues LDO1, Santos Júnior ACS1, Carvalho LMA1, Horta MGC1, Fernandes MR1, Avelar SOS1, Kelles SMB1
1 Unimed Belo Horizonte, Brazil
Presenting author and contact person

Presenting author:

Daniela Azevedo

Contact person:

Abstract text
Background: Secukinumab was approved to treat plaque psoriasis based on two phase III trials (ERASURE and FIXTURE). These resulted in one publication supporting the drug efficacy when compared to both placebo and another biologic drug. However, the manuscript does not detail the adverse events in the cardiovascular system, although higher cardiovascular risk has been reported in these patients.

Objectives:To assess the incidence of serious cardiovascular adverse events (SCVAE) and hypertension in secukinumab versus placebo groups in ERASURE and FIXTURE.

Methods:The data tables of the published article and supplementary appendix were analysed to look for SCVAE, including hypertension, in the secukinumab and placebo groups, during the 52-week treatment period.

Results:The data tables and supplementary appendices were analysed. All the events in the secukinumab group were analysed, independently of the dose. Statistical analyses were made using OpenEpi. In the ERASURE, 15 SCVAE (2,1%) were described in the secukinumab group as: 2 unstable angina, 2 cardiac failure, 2 coronary artery disease, 1 arrhythmia, 1 myocardial infarction, 1 carotid artery dissection, 1 ischemic stroke, 1 cerebrovascular accident, 1 aortic aneurysm, 1 aortic thrombosis, 1 hypertension and 1 hypertensive crisis. In the placebo group, there was no SCVAE (p= 0.014). In the FIXTURE, 10 SCVAE were described in the secukinumab group as: 1 angina pectoris, 1 angina unstable, 1 arteriosclerosis coronary, 1 myocardial infarction, 1 palpitations, 2 hypertensive crisis, cerebrovascular accident, 1 arterial occlusive disease, and 1 peripheral arterial occlusive. In the placebo group, again, there was no SCVAE (p= 0.049). Hypertension was more incident with secukinumab than with placebo in the ERASURE (5.9% vs. 1.2%; p=0.006) and in the FIXTURE (4.48% vs. 1.22%;p= 0.006). Conclusions: The pivotal secukinumab studies in psoriasis did not address clearly the higher incidence of SCVAE and hypertension.This is a problem, since the articles were written by medical writers paid by pharmaceutical industry, which likely influenced the concealed way adverse events were described.