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The FDA has approved bimekizumab for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Bimekizumab is a humanized monoclonal IgG1 antibody that selectively neutralizes both IL-7A and IL-17F, which are key cytokines driving inflammatory processes, and it’s the first and only approved psoriasis treatment that inhibits both cytokines.

Efficacy of Bimekizumab
The approval of bimekizumab is supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials—BE READY, BE VIVID, and BE SURE—which analyzed the efficacy and safety of the drug in 1,480 adults with moderate-to-severe plaque psoriasis. All of the trials met the co-primary endpoint and all ranked secondary endpoints. Within these trials, 85 percent to 91 percent of patients treated with bimekizumab achieved clear or almost clear skin at week 16, and approximately 59 percent to 68 percent of bimekizumab-treated patients achieved complete clearance. Following just one dose, more than seven in 10 patients achieved a Psoriasis Area and Severity Index (PASI) score of 75 by week four of treatment with bimekizumab.

Safety Profile of Bimekizumab
The safety profile of bimekizumab is comparable to other biologic therapies for psoriasis and is generally well-tolerated. The most common side effects reported are upper respiratory tract infections, such as nasopharyngitis, which affects more than 10 percent of people. Other common side effects include injection-site reactions, headache, diarrhea, fatigue, tooth pain, dry skin, and cold sores. However, it’s important to note that bimekizumab should not be used in patients with a history of hypersensitivity reactions.

Bimekizumab in Comparison to Other Biologics
Bimekizumab presents a unique approach in treating psoriasis by targeting both IL-17A and IL-17F cytokines. In comparison to other biologics, bimekizumab shows a higher rate of complete skin clearance, and its safety profile has been proven to be comparable to other biologics including:

• Bimekizumab vs. Ustekinumab: In the Phase 3 clinical trial, BE VIVID, bimekizumab was found to be more efficacious than ustekinumab in the treatment of moderate-to-severe plaque psoriasis. Bimekizumab-treated patients achieved significantly higher rates of skin clearance at week 16 compared to ustekinumab-treated patients. Bimekizumab also had a better safety profile than ustekinumab.
• Bimekizumab vs. Secukinumab: In a systematic literature review and network meta-analysis, bimekizumab was found to be more efficacious than secukinumab in terms of achieving PASI 75, PASI 90, and PASI 100 responses. However, there were no head-to-head comparisons of bimekizumab and secukinumab in clinical trials.
• Bimekizumab vs. Adalimumab: In a systematic literature review and network meta-analysis, bimekizumab was found to be more efficacious than adalimumab in terms of achieving PASI 75, PASI 90, and PASI 100 responses. However, there were no head-to-head comparisons of bimekizumab and adalimumab in clinical trials.

The approval of bimekizumab is a significant development in treating severe plaque psoriasis as it offers a new approach to manage the condition by targeting both IL-17A and IL-17F cytokines, resulting in better and more significant improvements in the skin’s condition. This offers patients, who may have been resistant to other biologics, an additional option to achieving complete skin clearance and better overall health.

References:
BIMZELX[®] approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. UCB. Accessed October 31, 2023. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis.

Manalac T. UCB wins FDA approval for plaque psoriasis therapy after regulatory setbacks. BioSpace. October 19, 2023. Accessed October 31, 2023. https://www.biospace.com/article/ucb-wins-fda-approval-for-plaque-psoriasis-therapy-after-regulatory-setbacks/.

Staff P. FDA approves bimekizumab for moderate-to-severe plaque psoriasis. Pharmacy Times. October 18, 2023. Accessed October 31, 2023. https://www.pharmacytimes.com/view/fda-approves-bimekizumab-for-moderate-to-severe-plaque-psoriasis.

Emma Andrus AE. FDA approves bimekizumab for moderate to severe plaque psoriasis. Dermatology Times. October 18, 2023. Accessed October 31, 2023. https://www.dermatologytimes.com/view/fda-approves-bimekizumab-for-moderate-to-severe-plaque-psoriasis.

Author links open overlay panelProf Kristian Reich MD a, a, b, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (be vivid): Efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. The Lancet. February 4, 2021. Accessed October 31, 2023. https://www.sciencedirect.com/science/article/abs/pii/S0140673621001252.

Bimekizumab in patients with psoriatic arthritis, naive to ... - the lancet. Accessed October 31, 2023. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02302-9/fulltext.

Armstrong A;Fahrbach K;Leonardi C;Augustin M;Neupane B;Kazmierska P;Betts M;Freitag A;Kiri S;Taieb V;Slim M;Gomez NN;Warren RB; Efficacy of bimekizumab and other biologics in moderate to severe plaque psoriasis: A systematic literature review and a network meta-analysis. Dermatology and therapy. Accessed October 31, 2023. https://pubmed.ncbi.nlm.nih.gov/35798920/.