AURIEL-PsO: A randomised, double-blind Phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB110222 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis
British Journal of Dermatology Jun 21, 2019
Hercogová J, et al. - In patients with moderate-to-severe chronic plaque-type psoriasis, researchers compared the effectiveness, safety and immunogenicity of MSB11022 [a proposed adalimumab biosimilar] with reference adalimumab via conducting a double-blind randomised controlled equivalence trial (AURIEL-PsO). For this investigation, study participants were randomised 1:1 to MSB11022 or reference adalimumab. In total, there were 443 randomized patients. No significant difference was noted in the incidence of treatment-emergent adverse events between treatment arms until the end of the trial and no new safety signals were observed. No clinically significant differences in safety or immunogenicity were observed between treatment arms until the end of the observation period following the treatment switch at Week 16. It was proved that there was a therapeutic equivalence between MSB11022 and reference adalimumab. AURIEL-PsO provides evidence to support the effectiveness, safety and immunogenicity similarities of both products.
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