Skyrizi (Risankizumab) for Moderate to Severe Plaque Psoriasis
For adults with moderate to severe plaque psoriasis, administer Skyrizi 150 mg subcutaneously at week 0, week 4, and every 12 weeks thereafter. 1
Dosing Regimen
- Standard dosing: 150 mg subcutaneous injection at weeks 0,4, then every 12 weeks for maintenance 2, 1
- Self-administration: Patients may self-inject after proper training using the prefilled pen or prefilled syringe 1
- Preparation: Remove from refrigerator and allow to reach room temperature (30-90 minutes for pen, 15-30 minutes for syringe) before injection 1
- Injection sites: Avoid areas where skin is tender, bruised, red, hardened, or affected by psoriasis; upper outer arm injections must be performed by healthcare professional or caregiver 1
Efficacy Benchmarks
- PASI 90 achievement: 75-77% of patients achieve ≥90% improvement at week 12 compared to 40-42% with ustekinumab 3, 2
- PASI 100 achievement: 36-45% of patients achieve complete clearance at week 16 2
- Superior to comparators: Risankizumab demonstrates superiority over ustekinumab, adalimumab, secukinumab, and fumaric acid esters in head-to-head trials 4, 5
- Long-term durability: At 6 years (week 304), 86% maintain PASI 90 and 54.2% maintain PASI 100 with continuous treatment 6
Response Assessment Timeline
Assess treatment response at 12 weeks of continuous therapy to determine definitive positive or negative response. 2
- For partial responders at 12 weeks: Add topical corticosteroids, vitamin D analogues, methotrexate, or ultraviolet B phototherapy 2
- Rapid onset: Significant improvement typically begins within the first 4 weeks of treatment 4
Pre-Treatment Requirements
Before initiating risankizumab, complete the following: 2, 1
- Screen for active infections, tuberculosis (TB), and malignancy 2
- Complete all age-appropriate vaccinations per current immunization guidelines, including pneumococcal and influenza vaccines 2, 1
- Establish baseline respiratory status if respiratory comorbidities exist 2
Special Populations and Considerations
- Age restriction: FDA-approved for adults only; no pediatric indication exists 7, 1
- Immunosuppression: Use caution in patients with pre-existing immunosuppression-related conditions 2
- Psoriatic arthritis: Risankizumab 150 mg at weeks 0,4, and every 12 weeks is also approved for psoriatic arthritis, either alone or combined with non-biologic DMARDs 1
Perioperative Management
- Before surgery: Discontinue risankizumab approximately 3-4 half-lives before elective surgery 2
- After surgery: Resume 1-2 weeks post-surgery if no complications occur 2
Safety Profile
Long-term safety data through 6 years (4921.2 patient-years of exposure) demonstrates: 6
- Low rates of treatment-emergent adverse events (TEAEs) 6
- Low rates of TEAEs leading to discontinuation 6
- Consistent safety profile maintained over extended treatment duration 6
- No new safety signals identified in long-term follow-up 5
Missed Dose Protocol
If a dose is missed, administer as soon as possible, then resume dosing at the regular scheduled time. 1
Clinical Positioning
Risankizumab represents a highly effective IL-23 inhibitor with superior efficacy compared to older biologics like ustekinumab and TNF inhibitors 3, 2. The convenient every-12-week dosing schedule after the initial loading phase offers practical advantages over biologics requiring more frequent administration 1. For patients failing other biologics, risankizumab demonstrates robust efficacy, with 66.1% of adalimumab non-responders achieving PASI 90 after switching 8.