BE VIVID is a 52-week, phase 3, randomised, double-blind trial investigating bimekizumab head-to-head with ustekinumab and placebo.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020).  The study randomised 567 patients with moderate-to-severe plaque psoriasis 4:2:1 to bimekizumab 320mg Q4W, ustekinumab 45/90mg Q12W, and placebo Q4W for 16 weeks of the initial treatment period.² After the initial treatment period, patients receiving placebo crossed over to receive bimekizumab 320mg Q4W, and the trial continued to week 52. Co-primary endpoints were 90% reduction in the Psoriasis Area and Severity Index (PASI 90) and Investigator’s Global Assessment (IGA) 0/1 at week 16.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020). 

Baseline patient characteristics were evenly distributed between treatment arms, and mean PASI scores at baseline ranged from 20.1 to 22.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020).  Majority of patients had IGA scores of 3 or 4, and almost 40% of all patients had received prior biologic therapy.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020). 

At week 16, bimekizumab displayed significant superiority (P<0.001) over both placebo and ustekinumab in patients achieving PASI 90 (85.0% vs. 4.8% and 49.7%, respectively), as well as patients achieving IGA 0/1 (84.1% vs. 4.8% vs. 53.4%, respectively).²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020). 

The proportion of patients achieving PASI 100 at week 16 was also significantly higher (P<0.001) with bimekizumab vs. ustekinumab and placebo (58.6% vs. 20.9% vs. 0%, respectively).²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020). PASI 75 response at week 4 was used as an indicator of the onset of response, for which 76.9% of patients receiving bimekizumab displayed, compared with 15.3% with ustekinumab and 2.4% with placebo (P<0.001 for both comparisons).[mfn referencenumber=2]2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020).[/mfn]

These PASI 90 and IGA 0/1 results were generally maintained over 52 weeks, with 81.6% and 77.9% of bimekizumab patients achieving PASI 90 and IGA 0/1 at week 52, compared with 55.8% and 60.7% of ustekinumab patients, respectively.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020).

Bimekizumab was well tolerated, with a safety profile consistent with previous studies.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020).  Most common treatment-emergent adverse events (TEAEs) with bimekizumab were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020). However, one major difference in the safety profile was the higher rates of drug-related TEAEs with bimekizumab (24.6% vs. 11.7% with ustekinumab), which was observed at both week 16 and week 52.²2. Reich K, et al. Session S27. Presented at the American Academy of Dermatology 2020 (June 12-14). Available at: https://aad.wistia.com/medias/xfapyslu8k (Accessed 3 July 2020).