General Information

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.

Dosing/Administration

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. 

Recommended Dosage

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.

Side Effects

Adverse effects associated with the use of Bimzelx may include, but are not limited to, the following:

• upper respiratory tract infections
•  oral candidiasis
• headache
• injection site reactions
• tinea infections
• gastroenteritis
• Herpes simplex infections
• acne
• folliculitis
• other candida infections
• fatigue

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.

All studies met their co-primary endpoints and all ranked secondary endpoints.

Patients treated with Bimzelx achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (ranked secondary endpoint, BE VIVID), placebo (co-primary endpoint, BE READY and BE VIVID) and adalimumab (co-primary endpoint, BE SURE), as measured by at least a 90 percent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). Ranked secondary endpoints included PASI 75 at week 4 and PASI 100 (complete skin clearance) at week 16.

Key findings across all studies include:

• Clear or Almost Clear Skin: More than eight out of 10 patients receiving Bimzelx (320 mg every four weeks [Q4W]) achieved PASI 90 and IGA 0/1 at week 16.
• Complete Skin Clearance: Approximately six out of 10 patients receiving Bimzelx (320 mg Q4W) achieved PASI 100 at week 16.
• Speed of Response: Clinical responses achieved with Bimzelx were rapid, with more than seven out of 10 patients achieving PASI 75 at week 4 following one dose (320 mg).
• Maintenance of Response: Clinical responses achieved with Bimzelx at week 16 (PASI 90 and PASI 100) were maintained for up to one year. Long-term data showed that clinical responses were maintained in the vast majority of patients through to three years of Bimzelx treatment.