Clinical Scorecard: Efficacy of AVT04, a Biosimilar to Ustekinumab, in Managing Plaque Psoriasis: Findings from a 28-Week Real-World Study

At a Glance

Key Highlights

• AVT04 demonstrated sustained clinical efficacy and safety over 28 weeks in both ustekinumab-naïve and switched patients.
• Complete remission rates were 54.5% in bio-naïve and 37.5% in bio-experienced ustekinumab-naïve patients.
• Switching from reference product ustekinumab to AVT04 was effective and safe, supporting biosimilar adoption.

Guideline-Based Recommendations

Diagnosis

• Diagnosis of plaque psoriasis should be based on clinical evaluation of characteristic red, scaly plaques and assessment of disease severity and comorbidities.

Management

• Use biologic therapies such as ustekinumab or its biosimilars for moderate-to-severe plaque psoriasis after inadequate response to conventional systemic therapies.
• Consider switching from reference biologic ustekinumab to biosimilar AVT04 to maintain efficacy and safety while reducing costs.
• Personalize treatment selection based on patient history, prior biologic exposure, and comorbidities.

Monitoring & Follow-up

• Monitor clinical response and remission status regularly during biologic therapy.
• Assess for adverse events and immunogenicity during treatment and after switching biologics.

Risks

• Potential risks include loss of efficacy or adverse effects; however, AVT04 showed comparable safety to the reference product.
• Consider individual patient factors and comorbidities when initiating or switching biologic therapy.

Patient & Prescribing Data

Patients with moderate-to-severe plaque psoriasis, including those naïve to ustekinumab and those switched from the reference product.

AVT04 biosimilar provides effective disease control with high remission rates and a favorable safety profile, supporting its use as a cost-saving alternative to the reference biologic.

Clinical Best Practices

• Evaluate patient biologic treatment history to guide initiation or switching decisions.
• Implement biosimilar use to improve healthcare resource utilization and patient access to biologic therapies.
• Regularly assess treatment efficacy and safety to optimize long-term disease management.

References

• European Medicines Agency - Biosimilars
• Italian National Health Service - Cost and Access Data
• Clinical Guidelines for Psoriasis Management