Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Some claims (general use, IL-17A mechanism, infection/TB/live vaccine timing) are supported by the provided label excerpts, but multiple cardiovascular risk and “regular heart checks” claims are not supported by the supplied prescribing information scope.
Category Scores
Accurate Statements
Cosentyx (secukinumab) is used to treat psoriasis.
Not supported by the provided excerpts (indication text not included in the excerpt set).
Cosentyx (secukinumab) works by targeting and blocking the action of interleukin-17A (IL-17A).
Not supported by the provided excerpts (mechanism details not included in the excerpt set).
COSENTYX may increase the risk of infections.
Section 5.1: “COSENTYX may increase the risk of infections.”
Serious bacterial, viral, and fungal opportunistic infections (including some fatal infections) have been reported with IL-17 inhibitors including COSENTYX.
Section 5.1: “In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections…”
Exercise caution when considering COSENTYX in patients with a chronic infection or a history of recurrent infection.
Section 5.1: “Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.”
If a patient develops a serious infection, monitor closely and discontinue COSENTYX until the infection resolves.
Section 5.1: “monitor… discontinue COSENTYX until the infection resolves.”
COSENTYX initiation is not recommended in patients with active TB infection; initiate treatment of latent TB prior to initiation.
Section 2.1 and 5.3: “COSENTYX initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior…” / “Avoid… active TB… Initiate treatment of latent TB prior…”
Evaluate patients for active or latent TB prior to initiating COSENTYX and monitor during and after treatment for signs/symptoms of active TB.
Section 5.3: “Evaluate… Monitor patients closely for signs and symptoms of active TB during and after treatment.”
COSENTYX may alter immune response to live vaccines; avoid live vaccines in patients treated with COSENTYX.
Section 5.7 and 12.2: “COSENTYX may alter a patient's immune response to live vaccines. Avoid use of live vaccines…”
Unsupported Statements
Cosentyx (secukinumab) is used to treat psoriatic arthritis.
Not supported by the provided excerpts (no indication listing for PsA included).
Cosentyx (secukinumab) is used to treat ankylosing spondylitis.
Not supported by the provided excerpts (no indication listing for AS included).
There is evidence suggesting a possible link between biologic medications like Cosentyx and an increased risk of cardiovascular events.
No cardiovascular risk statements are present in the provided excerpts.
A study in the Journal of the American College of Cardiology found that patients taking biologic medications for psoriasis were at higher risk of developing cardiovascular disease compared to those not taking these medications.
No journal-study references or cardiovascular findings are present in the provided excerpts.
Patients taking Cosentyx should be monitored closely for any signs of cardiovascular disease, especially those with pre-existing risk factors.
No cardiovascular monitoring recommendations are present in the provided excerpts.
Patients should undergo regular heart checks while taking Cosentyx.
No “heart checks” or cardiovascular monitoring frequency is present in the provided excerpts.
As a general rule, patients taking Cosentyx should undergo a heart check at least once a year.
No cardiovascular monitoring schedule or “once a year” instruction is present in the provided excerpts.
As a general rule, patients taking Cosentyx should undergo more frequent heart checks if they have pre-existing cardiovascular risk factors.
No cardiovascular monitoring frequency stratified by risk factors is present in the provided excerpts.
Cosentyx may increase the risk of cardiovascular events in some patients.
No cardiovascular risk statements are present in the provided excerpts.
Contradictions
Important Omissions
No label-backed information was provided regarding infections/TB/live vaccine precautions for the specific cardiovascular-monitoring claims (i.e., switching to an unsupported cardiovascular risk-management approach).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Cardiovascular-risk and cardiovascular-monitoring instructions were asserted without support from the provided prescribing information scope, which could lead to inappropriate monitoring focus.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Cardiovascular risk linkage and “heart check”/monitoring frequency recommendations are not supported by the provided COSENTYX prescribing information excerpts.
Suggested Improvement
Remove or revise all cardiovascular-risk and cardiovascular-monitoring claims; restrict safety-related statements to those present in the provided label excerpts (e.g., infection risk, TB evaluation/monitoring, live vaccine avoidance, and actions upon serious infection).