Partial
Mostly Aligned
Patient Risk:
Low
Summary
Indication claims are fully supported; certain mechanism-based statements are supported. A number of kidney-related safety claims are not described in the label and are therefore unsupported. Overall alignment reflects support for indications and some adverse events but substantial unsafe or unverified safety assertions reduce alignment.
Category Scores
Accurate Statements
Cosentyx is a biologic medication used to treat psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Supported
Cosentyx inhibits interleukin-17A (IL-17A).
Supported
Common side effects of Cosentyx include injection site reactions.
Supported
Common side effects of Cosentyx include upper respiratory tract infections.
Supported
Common side effects of Cosentyx include fatigue.
Supported
Unsupported Statements
Cosentyx may increase the risk of kidney problems.
Not supported by label.
Kidney problems may include acute kidney injury (AKI).
Not described in label.
Kidney problems may include chronic kidney disease (CKD).
Not described in label.
A study found that psoriasis patients who received Cosentyx had a higher incidence of AKI compared to those who received placebo.
Trial AKI risk not described in labeling.
Inhibition of IL-17A may contribute to kidney damage.
Label does not attribute kidney damage to IL-17A inhibition.
In CKD patients, Cosentyx was associated with a higher incidence of kidney function decline compared to placebo.
No CKD-specific data in label.
Cosentyx is protected by US Patent 9,419,857, which covers the use of secukinumab for treating psoriasis.
Patent information not in labeling.
Patients with pre-existing kidney conditions should be closely monitored for signs of kidney problems.
Label does not specify CKD monitoring guidance.
Regular blood tests should be performed to check kidney function and electrolyte imbalances.
No labeling guidance on routine nephro monitoring.
Urine tests should be performed to check for proteinuria.
No labeling guidance on urine testing for kidney function.
Urine tests should be performed to check for hematuria.
No labeling guidance on urine testing for kidney function.
Imaging studies such as ultrasound or CT scans should be performed to evaluate kidney structure and function.
No labeling guidance on routine imaging.
Cosentyx has not been specifically studied in patients with kidney transplant.
Label does not provide transplant-specific studies.
Cosentyx may be used in patients with kidney transplant under close monitoring.
No labeling guidance to use in transplant recipients.
Kidney function should be monitored regularly, ideally every 3-6 months, in patients taking Cosentyx with existing kidney conditions.
No label guidance on CKD monitoring cadence.
The long-term effects of Cosentyx on kidney function are not well understood and require further research.
Label does not discuss long-term renal outcomes.
Interleukin-17A (IL-17A) plays a role in the development of kidney fibrosis.
No label discussion of IL-17A in kidney fibrosis.
Contradictions
Important Omissions
No label guidance on nephro monitoring cadence or CKD-specific safety.
Importance:
Moderate
No label guidance on transplant use or safety in kidney transplant recipients.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
Overall alignment is driven by label-supported indications and common adverse events; unsupported kidney-related safety claims elevate perception of risk without label support.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Significant number of kidney-related safety claims are not supported by the label; should be restricted to label-supported information.
Suggested Improvement
Limit statements to label-supported indications and adverse events; remove speculation about AKI/CKD risk and transplant use; if discussing safety risks, cite label-approved warnings (e.g., infection risk, IBD) and clearly distinguish hypothetical content from label-supported content.