Currently Enrolling Trials
Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and F antagonist.
Bimzelx is specifically indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Bimzelx is supplied as an injection for subcutaneous administration.
Recommended Evaluations and Immunization Prior to Treatment Initiation
- Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Bimzelx. Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with Bimzelx. Complete all age-appropriate vaccinations as recommended by current immunization guidelines.
The recommended dosage of Bimzelx is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Mechanism of Action
Bimzelx (bimekizumab-bkzx) is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17receptor complex. IL17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.
Adverse effects associated with the use of Bimzelx may include, but are not limited to, the following:
- upper respiratory tract infections
- oral candidiasis
- injection site reactions
- tinea infections
- Herpes simplex infections
- other candida infections
Clinical Trial Results
The FDA approval of Bimzelx was based on data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of Bimzelx in 1,480 adults with moderate-to-severe plaque psoriasis.