What is the recommended treatment regimen for Ilumya (tildrakizumab) in adults with moderate to severe plaque psoriasis?

Ilumya (Tildrakizumab) Treatment Regimen for Moderate-to-Severe Plaque Psoriasis

Administer tildrakizumab 100 mg by subcutaneous injection at week 0, week 4, and then every 12 weeks thereafter. 1, 2

Dosing Schedule

• Initial loading doses: 100 mg at week 0 and week 4 1, 2
• Maintenance dosing: 100 mg every 12 weeks after the initial two doses 1, 2
• Route of administration: Subcutaneous injection 1, 2
• Administration setting: The FDA label indicates subcutaneous injection, though the AAD-NPF guideline specifies "in office physician-administered" 1, 2

Strength of Recommendation

• Grade A recommendation from the American Academy of Dermatology and National Psoriasis Foundation for tildrakizumab as monotherapy in adults with moderate-to-severe plaque psoriasis 1
• This represents the highest level of evidence (Level I) based on multiple randomized controlled trials 1

Efficacy Expectations

• PASI 75 response: 61-66% of patients achieve ≥75% improvement at week 12 3
• PASI 90 response: 58% of patients achieve ≥90% improvement at week 28 4
• PASI 100 response: 29-33% achieve complete clearance 4, 5
• Long-term efficacy: High proportion of patients maintain PASI response after 2 years of treatment 4
• Real-world data: Mean body surface area decreased by 83.1% through 64 weeks of treatment 5

Special Populations and Indications

Tildrakizumab is effective for difficult-to-treat areas including: 1, 6

• Scalp psoriasis (PSSI decreased from 36.2 to 2.7 at 28 weeks) 6
• Nail psoriasis (NAPSI decreased from 48.4 to 15.7 at 28 weeks) 6
• Palmoplantar psoriasis (ppPASI decreased from 5.3 to 0 at 28 weeks) 6
• Genital psoriasis (sPGA-G decreased from 3.3 to 0.2 at 28 weeks) 6

Pre-Treatment Evaluation

Before initiating tildrakizumab, evaluate for: 2

• Tuberculosis screening (required per FDA label) 2
• Active infections (serious or chronic) 2
• History of serious hypersensitivity reactions 2

Contraindications

Do not use tildrakizumab in patients with: 2

• Serious hypersensitivity reaction to tildrakizumab or any excipients 2

Dosing After Treatment Interruption

If doses are missed: 1

• Consider repeating loading doses (week 0 and week 4 schedule) if the patient is flaring and/or if more than 3-4 half-lives have passed since the previous dose 1
• The necessity of repeating loading doses depends on disease severity and duration of interruption 1

Safety Profile

• Most common adverse events (≥1%): Upper respiratory infections, injection site reactions, and diarrhea 2
• Long-term safety: No apparent dose-related differences in adverse events, low incidence of discontinuation, and no evidence of increased malignancy risk over 5 years 7
• Real-world safety: In a 64-week study, no treatment-emergent adverse events were considered related to tildrakizumab 5

Comparative Efficacy

Tildrakizumab demonstrated superiority to etanercept: 3

• PASI 75 at week 12: 61-66% with tildrakizumab 100-200 mg vs 48% with etanercept 50 mg (p<0.001 to p=0.001) 3
• Both 100 mg and 200 mg doses showed similar efficacy, supporting the 100 mg recommended dose 1, 3

Important Clinical Considerations

Avoid live vaccines during tildrakizumab treatment 2

Monitor for infections: Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur; consider discontinuing if serious infection develops 2

Predictive factors: Achievement of PASI 50 by week 8 predicts PASI 90 response at week 12, while baseline PASI score, PGA, and BMI are not predictive 4