Poor
Partially Aligned
Patient Risk:
Moderate
Summary
Many safety/pharmacology statements are generally consistent with label themes (infections risk; IL-23 p19 binding), but several specific claims (e.g., “mild to moderate” side effects, “commonly causes” specific AEs, timing/course of AEs, and “serious problems that include” example symptom lists) are not supported by the provided label excerpts. Several other important label-based items (e.g., TB evaluation, live vaccine avoidance, hypersensitivity discontinuation, and initiation not in active infection) are either omitted or not accurately reflected at the level of detail needed.
Category Scores
Accurate Statements
Skyrizi suppresses a specific immune pathway (IL-23).
Supported by Mechanism of Action: binds p19 subunit of IL-23 and inhibits interaction with IL-23 receptor (Section 12.1).
Skyrizi is used for certain immune-mediated conditions, including psoriasis.
Supported that SKYRIZI is indicated for moderate-to-severe plaque psoriasis (Section 1.1).
Skyrizi increases the risk of upper respiratory and other infections.
Label states SKYRIZI may increase the risk of infections (Section 5.2). Provided excerpts do not specifically restrict to URIs, but the general infection-risk theme is supported.
Even over time, risks like infections still apply with Skyrizi.
Supported broadly by the label statement that SKYRIZI may increase the risk of infections and trial experience includes infections (Section 5.2 and 6.1).
Patients may need additional monitoring on Skyrizi if they have plans for surgery or treatment that could raise infection risk.
Only partially inferable from label “consider risks and benefits” in chronic/recurrent infection (Section 5.2), but specific surgery language is not present in provided excerpts; therefore marked unsupported below if judged strictly. (This item is not included in unsupportedStatements because it is not directly contradicted; however, it is not clearly supported by the provided excerpts.)
Unsupported Statements
Skyrizi (risankizumab) most reported side effects are generally mild to moderate.
No provided label excerpt supports the characterization that the most reported side effects are “generally mild to moderate.”
Skyrizi commonly causes upper respiratory infections (such as cold-like symptoms).
Provided excerpts show infection rates but do not state “commonly causes” URIs or “cold-like symptoms.” (Section 6.1 excerpt provides overall infection frequencies, not specific URI/cold symptom descriptions.)
Skyrizi commonly causes headache.
No provided label excerpt mentions headache as a common adverse reaction.
Skyrizi commonly causes fatigue.
No provided label excerpt mentions fatigue as a common adverse reaction.
Skyrizi can cause injection-site reactions in people who self-inject, such as redness or discomfort.
No provided label excerpt mentions injection-site reactions, redness, or discomfort.
Because Skyrizi affects the immune system, infections are a main risk category patients monitor for.
Label indicates increased infection risk (Section 5.2) but does not provide patient-monitoring guidance in these exact terms in the provided excerpts.
Skyrizi can cause serious problems that include infections that do not go away or are getting worse (fever, worsening cough, painful urination).
Provided excerpts note increased infection risk and serious infections at a low rate, but do not provide this specific symptom list or define these as the serious infection examples.
Skyrizi can cause serious problems that include allergic reactions (hives, swelling of the face/lips, trouble breathing).
Label excerpt confirms serious hypersensitivity reactions including anaphylaxis (Section 5.1) but does not provide the listed example symptoms (hives, face/lip swelling, trouble breathing) in the provided excerpts.
Serious allergic reaction symptoms for Skyrizi include trouble breathing, facial swelling, and widespread hives.
Not supported by provided excerpts; only “serious hypersensitivity reactions, including anaphylaxis” is stated (Section 5.1).
Side effects of Skyrizi can occur at any time.
No provided label excerpt supports the claim about timing of side effects (“at any time”).
Injection-related reactions and upper respiratory symptoms are often noticed earlier in treatment with Skyrizi.
No provided label excerpt supports an “earlier in treatment” timing for injection-site reactions or UR symptoms.
Over time, many patients see fewer new issues with Skyrizi.
No provided label excerpt supports a trend that “many patients see fewer new issues” over time.
Skyrizi side effects are broadly similar across indications, but the rate of specific problems can vary by study populations and background treatments.
No provided label excerpt supports cross-indication similarity/variability by study populations or background treatments.
Infection risk remains a key shared concern across Skyrizi indications.
While infection risk is present generally (Sections 5.2 and 6.1), the claim that it is “key shared” across all indications is not explicitly supported by the provided excerpts.
Patients may need additional monitoring on Skyrizi if they have frequent infections or a serious infection history.
Label says in chronic infection or history of recurrent infection, consider risks and benefits prior to prescribing (Section 5.2), but does not specifically state “additional monitoring.”
Patients may need additional monitoring on Skyrizi if they have uncontrolled diabetes or other conditions that increase infection risk.
No provided label excerpt mentions diabetes or “uncontrolled diabetes” or specific conditions requiring additional monitoring.
Patients may need additional monitoring on Skyrizi if they have a current infection or recent exposure to infections needing evaluation.
Label states do not initiate in patients with clinically important active infection until resolved/adequately treated (Section 5.2) but does not mention “recent exposure” monitoring in the provided excerpts.
If a serious infection happens, clinicians may pause Skyrizi treatment until it is addressed.
Provided excerpt does not describe pausing/delaying therapy for serious infections; it only states treatment should not be initiated in active infection until resolved/treated (Section 5.2).
Patients are advised to seek care if they develop persistent fever or symptoms of infection while taking Skyrizi.
The provided excerpts do not include explicit patient advice phrasing about persistent fever/symptoms.
Patients are advised to tell their prescriber about any history of recurrent or chronic infections while taking Skyrizi.
Label supports considering risks/benefits in history of recurrent infection (Section 5.2) but does not provide the specific patient advisory statement.
Contradictions
Important Omissions
TB evaluation prior to initiating treatment; do not administer SKYRIZI to patients with active TB.
Importance:
High
Vaccination guidance (avoid live vaccines during treatment; complete age-appropriate vaccinations prior to initiating therapy).
Importance:
High
For Crohn’s disease and ulcerative colitis: baseline liver enzymes and bilirubin prior to initiating treatment and further evaluation during induction up to at least 12 weeks; interrupt if drug-induced liver injury suspected.
Importance:
Moderate
Contraindication: history of serious hypersensitivity reaction to risankizumab-rzaa or excipients.
Importance:
Moderate
No dosage/administration details were provided to evaluate; label-specific dosing differs by indication (subcutaneous vs IV, induction/maintenance schedules).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Several precise safety statements (e.g., “commonly causes” specific AEs; symptom examples; timing claims) are not supported by the provided excerpts. However, broad infection-risk and hypersensitivity existence themes are label-consistent, and IL-23 mechanism is supported. Omissions of TB screening, live vaccine avoidance, and initiation restrictions for active infection increase the chance the AI output could be incomplete for safe label-aligned use.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Multiple claims about “commonly” occurring adverse events and specific symptom examples/timing are unsupported by the provided label excerpts, and key label-directed monitoring items (TB screening, live vaccine avoidance, initiation restrictions for active infection, hepatotoxicity monitoring for CD/UC) are omitted.
Suggested Improvement
Restrict safety language to what the label excerpts support (e.g., SKYRIZI may increase infection risk; serious hypersensitivity can occur; do not initiate in clinically important active infection; evaluate for TB; avoid live vaccines; CD/UC baseline and follow-up liver tests). Remove or rephrase unsupported “commonly” and symptom-list/timing assertions to match the label wording or omit them when not explicitly present.