Bimekizumab-bkzx Approved for Adults With Moderate to Severe Plaque Psoriasis

The US Food and Drug Administration (FDA) recently announced approval of BIMZELX (bimekizumab-bkzx) for the treatment of adults with moderate to severe plaque psoriasis.¹

Bimekizumab-bkzx is the first and only approved psoriasis treatment that selectively inhibits IL-17A and IL-17F , the 2 key cytokines driving inflammatory processes.² The approval was granted following data from 3 Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE). These trials evaluated the efficacy and safety of bimekizumab-bkzx in 1480 adults with moderate to severe plaque psoriasis.^3-5 Particularly, in the Phase 3/3b trials, bimekizumab-bkzx showcased superior levels of skin clearance at week 16 compared to placebo and 3 current biologics for the treatment of psoriasis in responses that were rapid and lasted up to a year. Additionally, long-term data have shown that most patients maintained high levels of clinical response through 3 years.

The FDA recommended dosage is 320 mg of bimekizumab-bkzx administered as 2 subcutaneous injections of 160 mg each at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.² For patients weighing 120 kg or more, the FDA recommends that a dose of 320 mg every 4 weeks after week 16 may be considered. Bimekizumab-bkzx can be administered by a health care professional, or by patients after proper training. It is available as an autoinjector and a prefilled syringe and will be on the market in the United States in approximately 1 month.

Important safety information and caution when using bimekizumab-bkzx include a possible increased risk in suicidal ideation and behavior, increased risk of infections, possible liver biochemical abnormalities, possible inflammatory bowel disease, and a boxed warning against prescribing to patients with active tuberculosis infection. Additionally, the most common adverse reactions are upper respiratory infections, oral candidiasis, other Candida infections, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex Infections, acne, folliculitis, and fatigue.

References
1. BIMZELX approved by the U.S. FDA for the treatment of adults with moderate-to-severe plaque psoriasis. News release. UCB. October 18,2023. Accessed October 18,2023. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis

2. BIMZELX prescribing information. Accessed October 18, 2023. UCB. www.UCB-USA.com/Innovation/Products/BIMZELX

3. Reich K, Papp KA, Blauvelt A, 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. Lancet. 2021;397(10273):487-498. doi:10.1016/S0140-6736(21)00125-2

4. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. doi:10.1016/S0140-6736(21)00126-4

5. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130-141. doi:10.1056/NEJMoa2102388