Repeated switching between biosimilar ABP 654 and reference ustekinumab in patients with moderate-to-severe plaque psoriasis: a randomized double-blinded clinical trial to support interchangeability.
Andrew Blauvelt, Jerry Bagel, Andreas Pinter et al.
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In 30 seconds
This randomized double-blinded clinical trial evaluated the interchangeability of the biosimilar ABP 654 and reference ustekinumab in patients with moderate-to-severe plaque psoriasis. Among 453 patients who completed the run-in period, pharmacokinetic similarity was demonstrated with geometric mean ratios for AUCtau and Cmax of 0.93 and 0.95, respectively, both within the prespecified similarity margin. Efficacy and safety profiles were also comparable between groups.
Key findings
- Geometric mean ratio for AUCtau was 0.93 (90% CI 0.89-0.98), indicating pharmacokinetic similarity.
- Geometric mean ratio for Cmax was 0.95 (90% CI 0.90-1.00), also within the similarity margin.
- Efficacy and safety profiles were similar between the continued-use and switching groups.
- 453 patients completed the run-in period and were randomized into two groups.
Why it matters
Understanding the interchangeability of biosimilars with reference products is crucial for clinicians, as it can influence treatment decisions and patient management in conditions like moderate-to-severe plaque psoriasis.