What is the dosing regimen and treatment guidelines for Ixekizumab (Ixekizumab) for moderate to severe plaque psoriasis and active psoriatic arthritis?

Ixekizumab Dosing and Treatment Guidelines

Standard Dosing Regimen for Moderate-to-Severe Plaque Psoriasis

For adult patients with moderate-to-severe plaque psoriasis, administer ixekizumab 160 mg subcutaneously at week 0, followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks for maintenance. 1, 2, 3

Induction Phase (Weeks 0-12)

• Week 0: 160 mg (two 80 mg injections) 1, 3
• Weeks 2,4,6,8,10,12: 80 mg every 2 weeks 1, 3

Maintenance Phase (Week 16 onwards)

• 80 mg every 4 weeks 1, 2, 3

This regimen achieves rapid clinical response, with improvements visible as early as week 1, and 92.3% of patients achieving PASI 75 by week 52. 4, 5

Dosing for Active Psoriatic Arthritis

For patients with active psoriatic arthritis without extensive skin involvement, administer 160 mg at week 0, then 80 mg every 4 weeks. 3

For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the full plaque psoriasis induction regimen (160 mg at week 0, then 80 mg every 2 weeks until week 12, followed by 80 mg every 4 weeks). 1, 2, 3

• Ixekizumab may be combined with conventional DMARDs like methotrexate 3
• All assessed patients with psoriatic arthritis achieved ACR20 response in clinical trials 4

Pediatric Dosing (Ages 6-17 Years)

Weight-based dosing for pediatric patients with moderate-to-severe plaque psoriasis: 3

• >50 kg: 160 mg at week 0, then 80 mg every 4 weeks
• 25-50 kg: 80 mg at week 0, then 40 mg every 4 weeks
• <25 kg: 40 mg at week 0, then 20 mg every 4 weeks

Pediatric administration must be performed by a healthcare provider or trained caregiver; self-administration by pediatric patients has not been established as safe. 3

Efficacy by Psoriasis Subtype

Plaque Psoriasis (Strength A Recommendation)

• PASI 90 achieved in 80.8% of patients at week 52 4
• PASI 100 achieved in 48.7% of patients at week 52 4
• Superior efficacy compared to etanercept and ustekinumab 6

Scalp Psoriasis (Strength B Recommendation)

• 78% of patients achieve complete scalp clearance by week 48 1, 2

Nail Psoriasis (Strength B Recommendation)

• 51% of patients achieve complete nail clearance by week 48 1, 2

Erythrodermic Psoriasis (Strength B Recommendation)

• 75% of patients achieved clear or minimal disease (sPGA 0 or 1) at week 52 1, 2, 4

Generalized Pustular Psoriasis (Strength B Recommendation)

• 60% of patients achieved clear or minimal disease at week 52 1, 2, 4

Genital Psoriasis (Strength B Recommendation)

• 73% of patients show improvement at 12 weeks 2

Pre-Treatment Screening Requirements

Before initiating ixekizumab, complete the following mandatory evaluations: 3

• Tuberculosis screening: Perform tuberculin skin test or interferon-gamma release assay; do not initiate in active TB; treat latent TB before starting ixekizumab 3
• Age-appropriate vaccinations: Complete all recommended immunizations before treatment initiation 3
• Active infection assessment: Screen for active infections or sepsis; consult infectious disease if present 7
• Hepatitis B screening: Untreated hepatitis B is a relative contraindication 7
• Inflammatory bowel disease history: Document any IBD history, as ixekizumab may worsen or trigger IBD 2, 6

Treatment Response Assessment

Assess definitive treatment response after 12 weeks of continuous therapy. 1, 2

For Partial Responders at Week 12:

• Consider adding topical corticosteroids or vitamin D analogues 1, 2
• Consider adding methotrexate or narrowband UVB phototherapy 1
• No published data supports combining with other biologics 2

Expected Timeline:

• Initial response visible at week 1 5
• Optimal assessment at week 12 1, 2
• Sustained response through week 52 and beyond 4, 5

Critical Safety Considerations

Mucocutaneous Candida Infections

• Incidence: 1.9 per 100 patient-years 2
• Typically mild and responsive to standard antifungal treatment 2
• Does not require treatment discontinuation in most cases 6

Inflammatory Bowel Disease Risk

• Avoid ixekizumab in patients with active IBD or history of IBD 2, 6
• May cause exacerbations or new-onset IBD 2, 6
• Exercise caution and consider alternative biologics in this population 6

Immunogenicity

• Neutralizing antibodies develop in up to 17% of patients 2
• Associated with reduced drug concentrations and loss of efficacy 2
• Monitor for declining response over time 2

Common Adverse Events

• Nasopharyngitis, eczema, seborrheic dermatitis, urticaria, injection site reactions 4
• Most adverse events are mild to moderate 4, 5
• Dropout rate for adverse events is only 2% 8

Administration Technique

• Allow ixekizumab to reach room temperature for 30 minutes before injection 3
• Rotate injection sites (upper arms, thighs, abdomen) 3
• Avoid areas that are tender, bruised, erythematous, indurated, or affected by psoriasis 3
• Adult patients may self-inject after proper training 3
• Upper arm injections require caregiver or healthcare provider administration 3

Real-World Effectiveness Data

Bio-naïve patients demonstrate superior responses compared to bio-experienced patients: 8

• Bio-naïve patients show significantly higher PASI 90 and PASI 100 rates at week 12 (p<0.05) 8
• Anti-IL-17A-naïve patients achieve significantly higher PASI 90 responses at week 24 compared to anti-IL-17A-experienced patients (p<0.05) 8
• Real-world data confirms 90% PASI 75,72% PASI 90, and 57% PASI 100 response rates at 24 weeks 8