What is the recommended dosing protocol for Risankizumab (risankizumab) in the treatment of moderate to severe plaque psoriasis?

Risankizumab Dosing and Protocol for Moderate to Severe Plaque Psoriasis

Administer risankizumab 150 mg subcutaneously at weeks 0 and 4, then every 12 weeks thereafter for maintenance therapy in adults with moderate-to-severe plaque psoriasis. 1

Standard Dosing Regimen

• Loading phase: 150 mg subcutaneous injection at week 0 and week 4 1, 2
• Maintenance phase: 150 mg subcutaneous injection every 12 weeks starting at week 16 1, 3
• Administration method: Can be self-administered using either prefilled syringe or autoinjector device 4

Response Assessment Timeline

• Evaluate treatment response at 12 weeks of continuous therapy to determine definitive positive or negative response 1
• Expected efficacy at week 16: 75% of patients achieve PASI 90 (≥90% improvement in psoriasis severity) 2
• Complete clearance rates: 36-45% of patients achieve PASI 100 (complete skin clearance) at week 16 1

Management of Partial Responders

For patients showing partial response at 12 weeks, augment risankizumab with:

• Topical corticosteroids 1
• Vitamin D analogues 1
• Methotrexate 1
• Ultraviolet B phototherapy 1

Pre-Treatment Requirements

Mandatory screening before initiating therapy:

• Screen for active infections, tuberculosis, and malignancy 1
• Establish baseline respiratory status if respiratory comorbidities exist 1
• Complete prophylactic vaccinations against pneumococcal and influenza infections before starting treatment 1

Perioperative Management

• Discontinue risankizumab 3-4 half-lives before elective surgery (approximately 84-112 days, given the 28-day terminal half-life) 1, 3
• Resume therapy 1-2 weeks after surgery if no postoperative complications occur 1

Special Clinical Scenarios

Switching from other biologics:

• Direct switching without washout period is safe and effective for patients with suboptimal response to IL-17 inhibitors (secukinumab, ixekizumab) 5
• After switching from anti-IL-17 therapy, 57.4% achieve clear/almost clear skin at week 16 and 62.3% at week 52 5

Comparative efficacy positioning:

• Risankizumab demonstrates superior efficacy versus ustekinumab: 75% vs 42% achieving PASI 90 at week 12 1
• Superior to secukinumab, adalimumab, and fumaric acid esters in head-to-head trials 6

Pharmacokinetic Considerations

• Bioavailability: 89% following subcutaneous administration 3
• Time to peak concentration: 3-14 days after dosing 3
• Terminal half-life: Approximately 28 days 3
• Body weight impact: While statistically correlated with clearance, body weight does not require dose adjustment as it has no clinically meaningful impact on efficacy 3

Safety Monitoring

Use caution in patients with:

• Pre-existing immunosuppression-related conditions 1
• Active infections (temporary discontinuation required) 7

Common adverse events:

• COVID-19 infection (8.6%) and nasopharyngitis (5.7%) were most frequently reported 5
• Treatment-emergent adverse events occur in approximately 50% of patients but are similar across all biologic treatment groups 2

Age Restrictions

• FDA-approved for adults only (≥18 years of age) 8, 2
• For pediatric patients requiring biologic therapy, consider alternative agents with established pediatric safety profiles such as etanercept (approved for ages ≥4 years) 8

Long-Term Maintenance

• Efficacy is maintained through >2.5 years of continuous exposure with durable response rates 6
• No dose escalation or interval shortening is required for maintenance therapy 1