Risk of major cardiovascular events in patients with psoriasis receiving biologic therapies: a prospective cohort study.

BACKGROUND: The cardiovascular safety profile of biologic therapies used for psoriasis is unclear. OBJECTIVES: To compare the risk of major cardiovascular events (CVEs; acute coronary syndrome, unstable angina, myocardial infarction and stroke) in patients with chronic plaque psoriasis treated with adalimumab, etanercept or ustekinumab in a large prospective cohort. METHODS: Prospective cohort study examining the comparative risk of major CVEs was conducted using the British Association of Dermatologists Biologics and Immunomodulators Register. The main analysis compared adults with chronic plaque psoriasis receiving ustekinumab with tumour necrosis-α inhibitors (TNFi: etanercept and adalimumab), whilst the secondary analyses compared ustekinumab, etanercept or methotrexate against adalimumab. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using overlap weights by propensity score to balance baseline covariates among comparison groups. RESULTS: We included 5468 biologic-naïve patients subsequently exposed (951 ustekinumab; 1313 etanercept; and 3204 adalimumab) in the main analysis. The secondary analyses also included 2189 patients receiving methotrexate. The median (p25-p75) follow-up times for patients using ustekinumab, TNFi, adalimumab, etanercept and methotrexate were as follows: 2.01 (1.16-3.21), 1.93 (1.05-3.34), 1.94 (1.09-3.32), 1.92 (0.93-3.45) and 1.43 (0.84-2.53) years, respectively. Ustekinumab, TNFi, adalimumab, etanercept and methotrexate groups had 7, 29, 23, 6 and 9 patients experiencing major CVEs, respectively. No differences in the risk of major CVEs were observed between biologic therapies [adjusted HR for ustekinumab vs. TNFi: 0.96 (95% CI 0.41-2.22); ustekinumab vs. adalimumab: 0.81 (0.30-2.17); etanercept vs. adalimumab: 0.81 (0.28-2.30)] and methotrexate against adalimumab [1.05 (0.34-3.28)]. CONCLUSIONS: In this large prospective cohort study, we found no significant differences in the risk of major CVEs between three different biologic therapies and methotrexate. Additional studies, with longer term follow-up, are needed to investigate the potential effects of biologic therapies on incidence of major CVEs

Risk of major cardiovascular events in patients with psoriasis receiving biologic therapies: a prospective cohort study

Background: The cardiovascular safety profile of biologic therapies used for psoriasis is unclear. Objectives: To compare the risk of major cardiovascular events (CVEs; acute coronary syndrome, unstable angina, myocardial infarction and stroke) in patients with chronic plaque psoriasis treated with adalimumab, etanercept or ustekinumab in a large prospective cohort. Methods: Prospective cohort study examining the comparative risk of major CVEs was conducted using the British Association of Dermatologists Biologics and Immunomodulators Register. The main analysis compared adults with chronic plaque psoriasis receiving ustekinumab with tumour necrosis‐α inhibitors (TNFi: etanercept and adalimumab), whilst the secondary analyses compared ustekinumab, etanercept or methotrexate against adalimumab. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using overlap weights by propensity score to balance baseline covariates among comparison groups. Results: We included 5468 biologic‐naïve patients subsequently exposed (951 ustekinumab; 1313 etanercept; and 3204 adalimumab) in the main analysis. The secondary analyses also included 2189 patients receiving methotrexate. The median (p25–p75) follow‐up times for patients using ustekinumab, TNFi, adalimumab, etanercept and methotrexate were as follows: 2.01 (1.16–3.21), 1.93 (1.05–3.34), 1.94 (1.09–3.32), 1.92 (0.93–3.45) and 1.43 (0.84–2.53) years, respectively. Ustekinumab, TNFi, adalimumab, etanercept and methotrexate groups had 7, 29, 23, 6 and 9 patients experiencing major CVEs, respectively. No differences in the risk of major CVEs were observed between biologic therapies [adjusted HR for ustekinumab vs. TNFi: 0.96 (95% CI 0.41–2.22); ustekinumab vs. adalimumab: 0.81 (0.30–2.17); etanercept vs. adalimumab: 0.81 (0.28–2.30)] and methotrexate against adalimumab [1.05 (0.34–3.28)]. Conclusions: In this large prospective cohort study, we found no significant differences in the risk of major CVEs between three different biologic therapies and methotrexate. Additional studies, with longer term follow‐up, are needed to investigate the potential effects of biologic therapies on incidence of major CVEs

509 Association between biologics and major cardiovascular events in adult patients with plaque psoriasis: A cohort study in the British Association of Dermatologists Biologic Interventions Register (BADBIR)

The association between biologics and major cardiovascular events (CVEs) in adult patients with plaque psoriasis is unclear. We used prospective cohort data from BADBIR to compared CVE risk associated with different therapies in participants recruited 09/200710/2016. Anti-interleukin-12/23 agent-ustekinumab (UST) was compared with tumour necrosis factor-α inhibitors (TNFi)-etanercept (ETN) and adalimumab (ADA) in a main analysis and UST, ETN or MTX was compared with ADA in a sensitivity analysis. The primary outcome was fatal or non-fatal major CVEs including acute coronary syndrome, unstable angina, myocardial infarction and stroke occurring on therapy or within 90 days after the last dose. Propensity-score weighted Cox proportional hazards regression models estimated hazard ratios (HRs) with 95%confidence interval (CI). 5468 (951 UST and 4517 TNFi) and 7657 (951 UST, 1313 ETN, 2189 MTX and 3204 ADA) biologic naïve patients with plaque psoriasis were included in the main analysis and sensitivity analysis, respectively. No statistically significant differences in the risk of the primary outcome were observed on therapy (adjusted HR for UST vs TNFi:1.17[95% CI 0.492.27]; UST vs ADA:1.06[0.392.89]; ETN vs ADA:0.94[0.32.88]; MTX vs ADA:1.12[0.34.17]) or during drug therapy and within 90 days of the last dose (adjusted HR for UST vs TNFi:0.98[0.432.25]; UST vs ADA:0.87[0.332.3]; ETN vs ADA:0.82[0.282.36]; MTX vs ADA:1.06[0.343.28]). Thus, the risk of major CVEs should not be a key discriminator for choosing biologics for psoriasis treatment

Risk of Major Cardiovascular Events in Patients with Psoriasis Receiving Biologic Therapies: a Prospective Cohort Study

BackgroundThe cardiovascular safety profile of biologic therapies used for psoriasis is unclear.ObjectivesTo compare the risk of major cardiovascular events (CVE s; acute coronary syndrome, unstable angina, myocardial infarction and stroke) in patients with chronic plaque psoriasis treated with adalimumab, etanercept or ustekinumab in a large prospective cohort.MethodsProspective cohort study examining the comparative risk of major CVE s was conducted using the British Association of Dermatologists Biologics and Immunomodulators Register. The main analysis compared adults with chronic plaque psoriasis receiving ustekinumab with tumour necrosis-a inhibitors (TNF i: etanercept and adalimumab), whilst the secondary analyses compared ustekinumab, etanercept or methotrexate against adalimumab. Hazard ratios (HR s) with 95% confidence intervals (CI s) were calculated using overlap weights by propensity score to balance baseline covariates among comparison groups.ResultsWe included 5468 biologic-naïve patients subsequently exposed (951 ustekinumab; 1313 etanercept; and 3204 adalimumab) in the main analysis. The secondary analyses also included 2189 patients receiving methotrexate. The median (p25–p75) follow-up times for patients using ustekinumab, TNF i, adalimumab, etanercept and methotrexate were as follows: 2.01 (1.16–3.21), 1.93 (1.05–3.34), 1.94 (1.09–3.32), 1.92 (0.93–3.45) and 1.43 (0.84–2.53) years, respectively. Ustekinumab, TNF i, adalimumab, etanercept and methotrexate groups had 7, 29, 23, 6 and 9 patients experiencing major CVE s, respectively. No differences in the risk of major CVE s were observed between biologic therapies [adjusted HR for ustekinumab vs. TNF i: 0.96 (95% CI 0.41–2.22); ustekinumab vs. adalimumab: 0.81 (0.30–2.17); etanercept vs. adalimumab: 0.81 (0.28–2.30)] and methotrexate against adalimumab [1.05 (0.34–3.28)].ConclusionsIn this large prospective cohort study, we found no significant differences in the risk of major CVE s between three different biologic therapies and methotrexate. Additional studies, with longer term follow-up, are needed to investigate the potential effects of biologic therapies on incidence of major CVE s