Efficacy of AVT04 Biosimilar in Plaque Psoriasis: 28-Week Real-World Study

Overview

This 28-week real-world study demonstrated that AVT04, a biosimilar to ustekinumab, provides sustained clinical efficacy and safety in patients with moderate-to-severe plaque psoriasis. Both ustekinumab-naïve and switched patients showed significant clinical improvement, with notable remission rates in bio-naïve and bio-experienced groups.

Background

Plaque psoriasis is a chronic immune-mediated inflammatory skin disease affecting 2–3% of the global population, often requiring biologic therapies for moderate-to-severe cases. Ustekinumab, an IL-12/23 antagonist, has been an established treatment option since 2009. The introduction of biosimilars like AVT04 offers cost-effective alternatives that maintain comparable efficacy and safety profiles, potentially improving patient access and reducing healthcare expenditure.

Data Highlights

Key Findings

• Switching from reference product ustekinumab to AVT04 was effective and safe in real-world clinical practice.
• Among ustekinumab-naïve patients, 54.5% of bio-naïve and 37.5% of bio-experienced patients achieved complete remission after AVT04 treatment.
• AVT04 demonstrated sustained clinical efficacy over 28 weeks in both switched and naïve patient cohorts.
• Use of AVT04 biosimilar is cost-saving from the Italian NHS perspective, promoting efficient healthcare resource utilization.
• Biosimilar adoption may increase patient access to advanced biologic therapies for plaque psoriasis.

Clinical Implications

Clinicians can consider AVT04 as a safe and effective alternative to reference ustekinumab for managing moderate-to-severe plaque psoriasis, including in patients switching from the reference product. The cost savings associated with AVT04 may facilitate broader patient access to biologic treatments and optimize healthcare resource allocation.

Conclusion

AVT04 biosimilar offers a clinically effective and safe treatment option for plaque psoriasis, with real-world evidence supporting its use in both ustekinumab-naïve and switched patients. Its adoption may enhance treatment accessibility while reducing economic burden.

References

1. European Medicines Agency 2024 -- Approval of AVT04 Biosimilar
2. Italian National Health Service 2024 -- Economic Impact of Biosimilars
3. Tor Vergata University of Rome Study 2024 -- Real-World Efficacy of AVT04