Skyrizi and Oral Lesions
Skyrizi (risankizumab) is not associated with oral lesions as an adverse effect and can be safely used in patients with a history of oral lesions, as oral mucosal toxicity is not a recognized complication of IL-23 inhibition.
Evidence Base
The provided evidence focuses on oral lesions associated with EGFR tyrosine kinase inhibitors (TKIs), mTOR inhibitors, and other targeted cancer therapies—not IL-23 inhibitors like risankizumab 1. These are fundamentally different drug classes with distinct mechanisms of action and adverse event profiles.
Skyrizi Safety Profile
Risankizumab's established adverse events do not include oral lesions or stomatitis:
- The FDA label for Skyrizi lists hypersensitivity reactions, infections, tuberculosis risk, and hepatotoxicity (specifically in inflammatory bowel disease treatment) as the primary safety concerns 2
- Long-term safety data through 6 years (4,921.2 patient-years of exposure) showed low rates of treatment-emergent adverse events with no mention of oral mucosal complications 3
- Phase III trials and comprehensive reviews of risankizumab consistently report upper respiratory infections, nasopharyngitis, and injection site reactions as the most common adverse events—oral lesions are notably absent 4, 5, 6, 7
Why the Provided Evidence is Not Applicable
The guidelines and evidence provided address oral mucositis from:
- EGFR-TKIs (gefitinib, erlotinib, afatinib): These cause stomatitis in 13-72% of patients 1
- mTOR inhibitors: Associated with mIAS (mTOR inhibitor-associated stomatitis) in 73.4% of patients 1
- Chemotherapy and radiation: Cause oral mucositis through direct mucosal damage 1
These mechanisms are completely unrelated to IL-23 inhibition, which targets inflammatory pathways in psoriasis without causing direct mucosal toxicity 4, 5, 6.
Clinical Recommendations
For patients with pre-existing oral lesions:
- No dose adjustment or special monitoring for oral lesions is required when initiating Skyrizi, as this is not a drug-related concern 2
- Standard Skyrizi dosing applies: 150 mg subcutaneously at weeks 0,4, and every 12 weeks thereafter for psoriasis 2
- Avoid injection into areas where skin is affected by lesions (tender, bruised, erythematous, or indurated areas), but this refers to skin injection sites, not oral mucosa 2
If oral lesions are present, manage them according to their underlying etiology:
- For aphthous ulcers: Use topical corticosteroids (betamethasone 0.5 mg in 10 mL water rinse, clobetasol 0.05% ointment) as first-line therapy 8, 9
- For severe or refractory ulcers: Consider systemic corticosteroids (prednisone 30-60 mg daily for 1 week with taper) or intralesional triamcinolone 8, 9, 10
- These oral lesion treatments can be used concurrently with Skyrizi without interaction concerns 8, 9, 10
Critical Pitfall to Avoid
Do not confuse risankizumab with targeted cancer therapies (EGFR-TKIs, mTOR inhibitors) that do cause oral mucositis 1. The management algorithms for stomatitis from those agents (oral hygiene protocols, steroid mouthwashes, dose interruptions) are irrelevant to Skyrizi therapy 1, 10.