Bimekizumab-bkzx

Generic name: bimekizumab-bkzx Brand name: Bimzelx® Manufacturer: UCB, Inc Class: IgG1 monoclonal antibody Date of US Food and Drug Administration Approval: October 17, 20231UCB, Inc. BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis.October 17, 2023 Cost: US$7200 per syringe (160 mg)2UCB, Inc (USA)How Much Should I Expect to Pay for BIMZELX® (bimekizumab-bkzx)?.October 2023 For the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.3BIMZELX (bimekizumab) U.S. Prescribing Information. Accessed March 13, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdfGoogle Scholar Bimekizumab is a humanized IgG1 monoclonal antibody that selectively targets interleukin (IL) 17A, IL-17F, and IL-17AF cytokines. By binding to these cytokines, bimekizumab effectively blocks their interaction with the IL-17RA/IL-17RC receptor complex, thereby reducing inflammation. Elevated levels of IL-17A and IL-17F are typically observed in lesional psoriatic skin. Bimekizumab represents a breakthrough in psoriasis treatment, as it is the first approved therapy designed to selectively inhibit both IL-17A and IL-17F, thereby targeting 2 key cytokines involved in driving inflammatory processes.3BIMZELX (bimekizumab) U.S. Prescribing Information. Accessed March 13, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdfGoogle Scholar Bimekizumab may increase the risk of suicidal ideation and behavior, although a direct causal link has not been established. Infections are a potential risk, therefore, treatment should be postponed in patients with clinically significant active infections until resolution or adequate treatment is administered. Before initiating bimekizumab treatment, it is essential to assess patients for tuberculosis infection, and its use should be avoided in individuals with active tuberculosis. Liver biochemical abnormalities have been observed with bimekizumab; hence, regular monitoring of liver enzymes is advised, with consideration for discontinuation if treatment-related elevations occur. Cases of inflammatory bowel disease have been reported with IL-17 inhibitors, including bimekizumab; therefore, patients should be monitored for signs of inflammatory bowel disease, and treatment may need to be discontinued. Bimekizumab may also interfere with immunizations, so live vaccines should be avoided during treatment. Common adverse reactions include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, and fatigue.3BIMZELX (bimekizumab) U.S. Prescribing Information. Accessed March 13, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdfGoogle Scholar Bimekizumab is available as a solution for subcutaneous injection in either a single-dose prefilled syringe or single-dose prefilled autoinjector, with a concentration of 160 mg/mL. The recommended dosage involves administering 320 mg, consisting of 2 subcutaneous injections of 160 mg each. This dosage is given at weeks 0, 4, 8, 12, and 16, followed by injections every 8 weeks thereafter. For patients weighing ≥120 kg, health care providers may consider adjusting the dosage to 320 mg every 4 weeks after week 16. The efficacy and safety profile of bimekizumab were assessed in the following 3 Phase III studies: BE VIVID,4Reich K Papp KA Blauvelt A Langley RG Armstrong A Warren RB 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: 487-498https://doi.org/10.1016/s0140-6736(21)00125-2Google Scholar which compared bimekizumab with placebo and ustekinumab; BE READY,5Gordon KB Foley P Krueger JG Pinter A Reich K Vender R 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: 475-486https://doi.org/10.1016/s0140-6736(21)00126-4Google Scholar which evaluated bimekizumab versus placebo alone; and BE SURE,6Warren RB Blauvelt A Bagel J Papp KA Yamauchi P Armstrong A et al.Bimekizumab versus adalimumab in plaque psoriasis.N Engl J Med. 2021; 385: 130-141https://doi.org/10.1056/nejmoa2102388Google Scholar which compared bimekizumab with adalimumab. In all studies, both co-primary and secondary end points were achieved. At week 16, patients treated with bimekizumab had superior skin clearance compared with placebo, ustekinumab, and adalimumab, achieving at least 90% improvement in Psoriasis Area and Severity Index (PASI 90) and clear or almost clear skin according to the Investigator's Global Assessment scale (0/1). Key findings across studies include high rates of PASI 90 and Investigator's Global Assessment 0/1 achievement, with approximately 6 of 10 patients achieving complete skin clearance (PASI 100) at week 16. Rapid responses were observed, with most patients achieving PASI 75 after 1 dose at week 4. In addition, clinical responses achieved at week 16 were maintained for up to 1 year, with long-term data indicating sustained responses in most patients through 3 years of treatment. Plaque psoriasis is a chronic, immune-mediated, inflammatory skin disease with a significant disease burden, profoundly affecting patient quality of life.7Boehncke WH Psoriasis Schön MP. Lancet. 2015; 386: 983-994https://doi.org/10.1016/s0140-6736(14)61909-7Google Scholar,8Kimball AB Jacobson C Weiss S Vreeland MG Wu Y. The psychosocial burden of psoriasis.Am J Clin Dermatol. 2005; 6: 383-392https://doi.org/10.2165/00128071-200506060-00005Google Scholar Associated with an increased risk of severe comorbidities, such as cardiometabolic diseases, inflammatory bowel disease, malignancies, and depression, psoriasis poses additional challenges beyond its visible symptoms.9Oliveira M de FSP de Rocha B de O Duarte GV Psoriasis: classical and emerging comorbidities.Anais Bras Dermatol. 2015; 90: 9-20https://doi.org/10.1590/abd1806-4841.20153038Google Scholar Although various biologic therapies targeting immune pathways have offered relief for moderate to severe cases, a notable proportion of patients fail to achieve rapid and sustained skin clearance, affecting treatment satisfaction.10Gordon KB Blauvelt A Papp KA Langley RG Luger T Ohtsuki M et al.Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis.N Engl J Med. 2016; 375: 345-356https://doi.org/10.1056/nejmoa1512711Google Scholar, 11Griffiths CEM Reich K Lebwohl M van de Kerkhof P Paul C Menter A et al.Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials.Lancet. 2015; 386: 541-551https://doi.org/10.1016/s0140-6736(15)60125-8Google Scholar, 12Langley RG Elewski BE Lebwohl M Reich K Griffiths CEM Papp K et al.Secukinumab in plaque psoriasis — results of two phase 3 trials.N Engl J Med. 2014; 371: 326-338https://doi.org/10.1056/nejmoa1314258Google Scholar In the United States alone, it affects more than 7.5 million adults, including daily activities and relationships, beyond its visible symptoms.13Rachakonda TD Schupp CW Armstrong AW. Psoriasis prevalence among adults in the United States.J Am Acad Dermatol. 2014; 70: 512-516https://doi.org/10.1016/j.jaad.2013.11.013Google Scholar 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 https://www.ucb-usa.com/Sustainability/Affordability/Bimzelx-Pricing-Info#:~:text=Prescription%20drug%20prices%20can%20be,your%20prescription%20drug%20insurance%20plan