Bispecific Antibody Outperforms Adalimumab in Phase 3 Study in Psoriasis

No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.
The Center for Biosimilars Staff
December 17, 2019
No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.

Drug maker UCB announced this month that a phase 3 active-controlled trial of its investigational bispecific antibody, bimekizumab, which targets interleukin 17A and 17F, showed superiority to adalimumab (Humira) in treating psoriasis.

The study, BE SURE, enrolled 480 patients with chronic plaque psoriasis who received either 1 of 2 possible dosing regimens of bimekizumab or received adalimumab. The coprimary endpoints of the study were 90% improvement in Psoriasis Area and Severity Index (PASI) score and investigator global assessment (IGA) response of clear or almost clear skin.

The drug met the primary endpoints at week 16, says UCB, as well as its ranked secondary endpoints, including superior total skin clearance versus adalimumab at weeks 16 and 24 as measured by PASI 100. Patients also had a faster response to the bispecific antibody than they did to adalimumab.

The safety and efficacy of bimekizumab are also being evaluated in patients with other inflammatory diseases, including psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Top-line results are anticipated by the end of 2021.

The drug also outperformed ustekinumab (Stelara) in another phase 3 study, BE VIVID, a 52-week trial in patients with psoriasis. In that study, bimekizumab met the co-primary endpoints of PASI90 and IGA score of clear or almost clear, demonstrating greater efficacy versus both placebo and ustekinumab.
 
Additionally, in the BE ABLE study, also in patients with psoriasis, 79% of patients treated with the bispecific achieved at least PASI90 at week 12, significantly outperforming placebo.

These results come as some experts warn that, by the time that biosimilars of adalimumab become available, patients will have moved on to more effective therapies and will be unwilling to opt for the older adalimumab, and that the biosimilar options may have less of an impact on the high-cost market for biologics in the United States than had previously been hoped.
 

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