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AUTOIMMUNE DISORDERS
One-year data of bimekizumab versus ustekinumab for plaque psoriasis in the BE VIVID trial
Medical writer: Kirsty LEE | Last updated: 3rd July 2020 | In: AutoImmune Disorders, Dermatology
Article Keywords
bimekizumab, IGA, IgG1, IL-17A, IL-17F, Janssen, JNJ, PASI, plaque psoriasis, psoriasis, Stelara, UCB, ustekinumab
Psoriasis is a chronic inflammatory skin disease that affects 1-3% of adults in western countries.11. Reis J, et al. BioDrugs. 2019 Aug;33(4):391-399. Development of biologic treatments over the past two decades has changed the treatment landscape for inflammatory diseases, including plaque psoriasis. Bimekizumab is a humanised monoclonal IgG1 antibody inhibiting IL-17A and IL-17F that is under investigation for plaque psoriasis in the BE VIVID trial.1,21. Reis J, et al. BioDrugs. 2019 Aug;33(4):391-399.
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). The 1-year results of BE VIVID were presented by Dr Kristian Reich during the American Academy of Dermatology 2020 virtual annual meeting (June 12-14, 2020).
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 absolute difference between the bimekizumab and ustekinumab arms was over 30%, which was quite significant, and one of the highest deltas we have seen in such comparator trials,” said Dr Reich.
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).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).
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).
Reference
- Reis J, et al. BioDrugs. 2019 Aug;33(4):391-399.
- 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).
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This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2020 MediPaper Medical Communications Ltd. – One-year data of bimekizumab versus ustekinumab for plaque psoriasis in the BE VIVID trial
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© Copyright 2020 MediPaper Medical Communications Ltd. – One-year data of bimekizumab versus ustekinumab for plaque psoriasis in the BE VIVID trial
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