Does Cosentyx Cause Heart Problems?
Cosentyx (secukinumab), an IL-17 inhibitor for psoriasis, psoriatic arthritis, and ankylosing spondylitis, carries warnings for major adverse cardiovascular events (MACE) like heart attack, stroke, and cardiovascular death. These risks were identified in clinical trials and post-marketing data, particularly in patients with heart disease history. The label notes higher MACE rates in treated groups versus placebo, though causality isn't proven—confounding factors like patient age and comorbidities play a role.[1][2]
What Do Clinical Trials Show?
In psoriasis trials pooling over 3,400 patients, MACE occurred in 0.9% of Cosentyx users (54 events) versus 0.5% on placebo (7 events) over about 50 weeks. Stroke rates were 0.2% versus 0.1%, and heart failure 0.1% versus 0.2%. Longer-term data from extension studies up to 5 years showed stable incidence, but trials excluded high-risk heart patients, limiting generalizability.[1][3]
Who Is Most at Risk?
Patients over 50 with coronary artery disease, diabetes, high blood pressure, or high cholesterol face elevated MACE risk—up to 1.4% in subgroup analyses. Pre-existing heart conditions amplify concerns; the FDA recommends monitoring these patients closely, weighing benefits against risks.[1][2]
How Common Are Reports in Real-World Use?
Post-approval surveillance via FDA's FAERS database logs hundreds of cardiovascular events linked to Cosentyx, including myocarditis, pericarditis, and arrhythmias. A 2023 analysis found 1.2 serious heart events per 1,000 patient-years, higher than etanercept but similar to other biologics. Underreporting is possible.[4][5]
What Do Guidelines Say About Monitoring?
Novartis advises baseline cardiovascular assessment and ongoing checks for symptoms like chest pain or shortness of breath. Discontinue if serious events occur. No routine EKGs or troponin tests are mandated, but rheumatologists often screen high-risk patients before starting.[1][6]
Compared to Other Biologics
Cosentyx's MACE signal matches TNF inhibitors like Humira (1.0% rate) but exceeds IL-23 inhibitors like Tremfya (0.4%). A head-to-head psoriasis trial showed no significant difference versus ustekinumab.[3][7]
[1]: Cosentyx Prescribing Information (FDA)
[2]: FDA Drug Safety Communication on IL-17 Inhibitors
[3]: NEJM: Secukinumab Safety Profile
[4]: FAERS Public Dashboard (FDA)
[5]: JAMA Dermatology: Cardiovascular Risks of Biologics
[6]: ACR Guidelines for Psoriatic Arthritis
[7]: Lancet: IL-17 vs IL-23 Inhibitors Meta-Analysis