Alvotech Highlighted 52wk. Study Results of AVT04 (biosimilar, ustekinumab) for Chronic Plaque Psoriasis
- The 52wk. study evaluating the safety, efficacy, tolerability, immunogenicity, and PK b/w AVT04 and originator ustekinumab in a ratio (1:2) in patients with mod. to sev. chronic PsO
- The results showed the therapeutic equivalence b/w AVT04 and reference ustekinumab. The study met its 1EPs & showed PASI improvement was 87.3% vs 86.8% & the incidence of Abs to ustekinumab had no clinically meaningful impact, the proportion of patients who achieved PASI50, PASI75, PASI90, and PASI100 before and after switching was similar across treatment arms with no clinically significant differences
- 34.5% vs 33.6% experienced TEAEs. Ustekinumab, an interleukin-12 (IL-12) and IL-23 inhibitor was approved to treat a variety of inflammatory diseases, incl. PsO
Ref: HCL Live | Image: Alvotech
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