AVT02 as effective as reference adalimumab in moderate-to-severe plaque psoriasis

Key clinical point: The biosimilar AVT02 is as efficacious, safe, and immunogenic as its originator, adalimumab, in moderate-to-severe chronic plaque psoriasis.

Major finding: At week 16, AVT02 and originator adalimumab induced comparable percentage improvement in Psoriasis Area Severity Index (91.6% and 89.6%, respectively), with the difference in percentage improvement within the predefined equivalence margins of ±10% (90% CI, −0.76 to 5.29), along with similar safety, tolerability, and immunogenicity profiles, which lasted through week 50.

Study details: This was a phase 3 study including 413 adult patients with moderate-to-severe chronic plaque psoriasis who were initially assigned to receive AVT02 or adalimumab; at week 16, the latter were randomly reassigned to continue receiving adalimumab or switch to AVT02 until week 48.

Disclosures: The study was sponsored by Alvotech Swiss AG. SR Feldman and R Kay disclosed receiving research grants, speaker honoraria, or consultancy fees from various sources, including Alvotech, and some of the authors declared being employees of Alvotech.

Source: Feldman SR et al. BioDrugs. 2021 Oct 16. doi: 10.1007/s40259-021-00502-w.

Key clinical point: The biosimilar AVT02 is as efficacious, safe, and immunogenic as its originator, adalimumab, in moderate-to-severe chronic plaque psoriasis.

Major finding: At week 16, AVT02 and originator adalimumab induced comparable percentage improvement in Psoriasis Area Severity Index (91.6% and 89.6%, respectively), with the difference in percentage improvement within the predefined equivalence margins of ±10% (90% CI, −0.76 to 5.29), along with similar safety, tolerability, and immunogenicity profiles, which lasted through week 50.

Study details: This was a phase 3 study including 413 adult patients with moderate-to-severe chronic plaque psoriasis who were initially assigned to receive AVT02 or adalimumab; at week 16, the latter were randomly reassigned to continue receiving adalimumab or switch to AVT02 until week 48.

Disclosures: The study was sponsored by Alvotech Swiss AG. SR Feldman and R Kay disclosed receiving research grants, speaker honoraria, or consultancy fees from various sources, including Alvotech, and some of the authors declared being employees of Alvotech.

Source: Feldman SR et al. BioDrugs. 2021 Oct 16. doi: 10.1007/s40259-021-00502-w.

Key clinical point: The biosimilar AVT02 is as efficacious, safe, and immunogenic as its originator, adalimumab, in moderate-to-severe chronic plaque psoriasis.

Major finding: At week 16, AVT02 and originator adalimumab induced comparable percentage improvement in Psoriasis Area Severity Index (91.6% and 89.6%, respectively), with the difference in percentage improvement within the predefined equivalence margins of ±10% (90% CI, −0.76 to 5.29), along with similar safety, tolerability, and immunogenicity profiles, which lasted through week 50.

Study details: This was a phase 3 study including 413 adult patients with moderate-to-severe chronic plaque psoriasis who were initially assigned to receive AVT02 or adalimumab; at week 16, the latter were randomly reassigned to continue receiving adalimumab or switch to AVT02 until week 48.

Disclosures: The study was sponsored by Alvotech Swiss AG. SR Feldman and R Kay disclosed receiving research grants, speaker honoraria, or consultancy fees from various sources, including Alvotech, and some of the authors declared being employees of Alvotech.

Source: Feldman SR et al. BioDrugs. 2021 Oct 16. doi: 10.1007/s40259-021-00502-w.