Poor
Partially Aligned
Patient Risk:
Medium
Summary
Several safety-related claims align with the label at a high level (infections, TB evaluation, avoid live vaccines, avoid active infection), but many specific quantitative rates, mechanistic assertions beyond the label, FAERS/database assertions, comparative claims versus other drugs, and dose/comorbidity-related risk statements are not supported by the provided label excerpts and/or are not directly stated as such.
Category Scores
Accurate Statements
STELARA may increase the risk of infections and reactivation of latent infections.
Section 5.1 Infections: 'STELARA may increase the risk of infections and reactivation of latent infections.'
Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving STELARA.
Section 5.1 Infections: 'Serious bacterial, mycobacterial, fungal, and viral infections were observed...'
Avoid initiating treatment with STELARA in patients with any clinically important active infection until the infection resolves or is adequately treated.
Section 5.1 Infections: 'Avoid initiating... active infection until the infection resolves or is adequately treated.'
Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA.
Section 5.3 Pre-treatment Evaluation for Tuberculosis: 'Evaluate patients for tuberculosis infection prior to initiating...'
Avoid administering STELARA to patients with active tuberculosis infection; initiate treatment of latent tuberculosis prior to administering STELARA.
Section 5.3 Pre-treatment Evaluation for Tuberculosis.
Patients being treated with STELARA should avoid receiving live vaccines.
Section 5.7 Immunizations: 'Patients being treated with STELARA should avoid receiving live vaccines.'
STELARA binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines.
Section 12.1 Mechanism of Action: 'binds... to the p40 protein subunit used by both the IL-12 and IL-23 cytokines.'
Unsupported Statements
Stelara (ustekinumab) suppresses parts of the immune system by blocking IL-12 and IL-23 cytokines.
Label excerpt supports binding to the p40 subunit used by IL-12 and IL-23, but 'blocking IL-12 and IL-23 cytokines' is not explicitly stated in the provided label excerpts.
The FDA label warns of an increased risk of serious infections with Stelara.
The provided label excerpt states increased risk of infections, but does not specifically phrase 'increased risk of serious infections' (it lists serious bacterial/mycobacterial/fungal/viral infections observed).
The FDA label advises monitoring patients for tuberculosis.
Provided excerpts include pre-treatment evaluation and avoidance/latent treatment, but do not explicitly state ongoing 'monitoring' for tuberculosis.
Patients on Stelara report upper respiratory infections most frequently.
No frequency/ranking of infection types is provided in the excerpts.
Upper respiratory infections occur in about 20% to 25% of patients in trials on Stelara.
No such quantitative trial frequency is provided in the excerpts.
Nasopharyngitis is reported in patients taking Stelara.
No such specific adverse event examples are provided in the excerpts.
Sinusitis is reported in patients taking Stelara.
No such specific adverse event examples are provided in the excerpts.
Serious cases linked to Stelara include pneumonia.
The label excerpt provided discusses 'Infections' and 'Noninfectious Pneumonia' (interstitial/eosinophilic/cryptogenic organizing pneumonia), but does not explicitly list 'pneumonia' as a serious infection example in the provided text.
Serious cases linked to Stelara include cellulitis.
No such specific adverse event examples are provided in the excerpts.
Serious cases linked to Stelara include herpes zoster (shingles).
No such specific adverse event example is provided in the excerpts.
Serious cases linked to Stelara include sepsis.
No such specific adverse event example is provided in the excerpts.
In psoriasis studies, serious infections occurred in 2.8% of Stelara users versus 0.6% on placebo over 76 weeks.
Specific study percentages and durations are not present in the provided label excerpts.
Stelara targets Th1 and Th17 immune pathways.
The label excerpt only states binding to p40 used by IL-12 and IL-23; it does not explicitly say 'Th1 and Th17 immune pathways' in the provided excerpts.
Targeting Th1 and Th17 immune pathways impairs defenses against intracellular pathogens like Mycobacterium tuberculosis.
The label excerpt supports TB reactivation risk and evaluation, but this specific mechanistic phrasing is not explicitly provided.
The risk of infections rises with Stelara doses over 90 mg.
No dose-response infection-risk statement is provided in the excerpts.
The risk of infections rises with concurrent immunosuppressants taken with Stelara.
No such statement is provided in the excerpts.
The risk of infections rises with comorbidities such as diabetes.
No such statement is provided in the excerpts.
Elderly patients taking Stelara have elevated odds of infections.
The provided geriatric excerpt states insufficient numbers to determine differential response; it does not state elevated odds.
Patients with chronic lung disease taking Stelara have elevated odds of infections.
No such statement is provided in the excerpts.
Patients taking corticosteroids with Stelara have elevated odds of infections.
No such statement is provided in the excerpts.
In Crohn's disease trials, serious infections occurred in 5.4% of Stelara-treated patients versus 3% on placebo.
Specific percentages and comparative trial outcomes are not present in the provided excerpts.
Stelara should be discontinued if serious infections develop.
The infections section provided advises avoidance of initiation and TB precautions, but the provided excerpt does not explicitly instruct discontinuation upon 'serious infections develop.'
Post-approval surveillance via FDA's FAERS database logs thousands of infection cases associated with Stelara.
No FAERS/database usage or quantitative statements are provided in the label excerpts.
Opportunistic infections such as Pneumocystis jirovecii pneumonia are reported in FAERS for Stelara.
No FAERS or Pneumocystis jirovecii pneumonia-specific claim is provided in the excerpts.
Stelara's serious infection rate of 3% to 5% is lower than TNF blockers like Humira, which is stated to be up to 8%.
No comparative numerical statements versus TNF blockers or 'Humira' are provided in the excerpts.
Stelara's serious infection rate is similar to other IL inhibitors like Cosentyx.
No comparative numerical statements versus Cosentyx or other IL inhibitors are provided in the excerpts.
Contradictions
Low
AI Statement
Stelara should be discontinued if serious infections develop.
Label Reference
Section 5.1 Infections excerpt provided does not explicitly state discontinuation for serious infections; it only advises avoiding initiation in active infections until resolved/treated.
Important Omissions
Exact contraindication language for hypersensitivity (clinically significant hypersensitivity to ustekinumab or excipients) was not evaluated by the AI response (it contains no contraindication statement).
Importance:
Moderate
No dosing/administration details were provided; therefore, labeling-required regimen specifics (weight-based dosing, Crohn's/UC induction/maintenance timing, pediatric eligibility) were not addressed by the AI response.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Medium
While the AI response generally reflects the label's infection/TB/livce vaccine risk at a high level, multiple unsupported quantitative and mechanistic/comparative claims could mislead risk perception; the missing explicit guidance for discontinuation is also a potential safety-relevant gap.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Many specific details (rates, adverse event examples, FAERS statements, comparative drug risk numbers, and dose/comorbidity modifiers) are not supported by the provided prescribing-information excerpts.
Suggested Improvement
Restrict claims to what is explicitly stated in the label excerpts: infections (types/categories), TB pre-treatment evaluation and latent TB initiation/avoid active TB, live vaccine avoidance, and the mechanism description (p40 binding). Remove or qualify all unlabeled quantitative/FAERS/comparative and detailed mechanistic statements unless the exact label text is provided.