Partial
Partially Aligned
Patient Risk:
Low
Summary
Several factual claims about indications and trial existence are supported by the provided label excerpts (Indications and Clinical Studies sections). However, multiple claims are either too broadly phrased relative to the excerpt support (e.g., “multiple major phase 3 programs,” “most commonly searched,” “large” studies) or are not supported at all in the provided excerpts (e.g., regulators’ submissions/medical literature; continued additional-indication study). The audit is also limited by missing other labeling sections (e.g., boxed warnings/contraindications/warnings).
Category Scores
Accurate Statements
Cosentyx is indicated for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older.
1.1
Cosentyx is indicated for active psoriatic arthritis in adults and pediatric patients 2 years of age and older.
1.2
Cosentyx is indicated for active ankylosing spondylitis in adults and pediatric patients 12 years and older.
1.3
Cosentyx is indicated for active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation.
1.4
Plaque psoriasis Phase 3 trials PsO1–PsO4 are described in adults (including dosing and endpoints such as PASI 75 and IGA).
14.1
Psoriatic arthritis Phase 3 trials PsA1–PsA3 are described in adult patients (including joint outcomes such as ACR responses and skin lesion improvement in patients with coexistent PsO measured by PASI).
14.3
Ankylosing spondylitis Phase 3 trials AS1–AS3 are described.
14.4
Non-radiographic axial spondyloarthritis Phase 3 trial nr-axSpA1 is described.
14.5
Clinical trial experience includes adverse reactions/infections reported and discussed in the label excerpt.
6.1
Trial outcomes for plaque psoriasis include PASI and IGA; for PsA include ACR responses and skin improvement in patients with coexistent PsO measured by PASI; for AS and nr-axSpA include ASAS response criteria and related disease activity measures.
14.1, 14.3, 14.4, 14.5
Unsupported Statements
Trial results reported in regulators’ submissions and medical literature supported Cosentyx approvals across these indications.
The provided label excerpts do not mention regulators’ submissions or medical literature as support for approvals.
Cosentyx has continued to be studied for additional inflammatory indications and for specific patient subgroups.
The provided excerpts do not support the specific continuity/additional-indication phrasing as stated.
Contradictions
Important Omissions
Boxed warning status, contraindications, and detailed warnings/precautions content are not provided in the label excerpts, preventing evaluation of safety claims tied to those sections.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The evaluated claims are primarily about study programs/outcomes and do not include dosing, contraindications, boxed warnings, or specific safety advice. However, some safety-related wording is broader than what the excerpts explicitly substantiate, and other critical label safety sections are not included.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Partially Aligned
Primary Issue
Multiple claims are either not supported in the provided excerpts (regulators’ submissions/medical literature; continued study for additional indications) or are overly broad relative to what the excerpts explicitly state (e.g., “multiple major,” “most commonly searched,” “large,” and combined skin/joint outcome wording).
Suggested Improvement
Rephrase broad claims to match the label excerpt language (e.g., cite specific named Phase 3 trials/sections rather than using umbrella descriptors), and remove or qualify statements not evidenced by the provided excerpts (e.g., regulators’ submissions, “continued” additional indications).