Bimekizumab Dosing Regimen for Moderate to Severe Plaque Psoriasis
The recommended dosing regimen for bimekizumab in adults with moderate to severe plaque psoriasis is 320 mg by subcutaneous injection at Weeks 0,4,8,12, and 16, then every 8 weeks thereafter. 1
Dosing Details and Administration
- Initial loading phase: 320 mg at Weeks 0,4,8,12, and 16
- Maintenance phase: 320 mg every 8 weeks after Week 16
- For patients weighing ≥120 kg, consider 320 mg every 4 weeks after Week 16 1
- Administration is via subcutaneous injection
- Each 320 mg dose can be administered as:
- One 320 mg/2 mL prefilled syringe/autoinjector, or
- Two separate 160 mg/1 mL prefilled syringes/autoinjectors
Administration Guidelines
- If using two separate 160 mg injections, administer at different anatomic locations 1
- Suitable injection sites include thighs, abdomen, or back of upper arm
- Rotate injection sites with each dose
- Do not inject within 2 inches of the navel or into areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis 1
Pre-Treatment Evaluation
Before initiating bimekizumab, the following evaluations are required:
- Tuberculosis (TB) screening
- Liver enzyme testing (ALT, AST, alkaline phosphatase, bilirubin)
- Complete age-appropriate vaccinations per current guidelines 1
Efficacy Profile
Bimekizumab has demonstrated high efficacy in clinical trials:
- 91% of patients achieved PASI90 (90% improvement in Psoriasis Area Severity Index) at Week 16 2
- 93% achieved IGA 0/1 (clear or almost clear skin) at Week 16 2
- Responses were maintained through Week 56 with both every 4-week and every 8-week maintenance dosing 2
- Bimekizumab showed superior efficacy compared to ustekinumab, with 85% of patients achieving PASI90 versus 50% with ustekinumab at Week 16 3
Safety Considerations
The most common adverse events reported with bimekizumab include:
- Nasopharyngitis (19.1 per 100 person-years)
- Oral candidiasis (12.6 per 100 person-years) - typically mild to moderate in severity
- Upper respiratory tract infection (8.9 per 100 person-years) 4
Important Safety Warnings
- Monitor for signs of suicidal ideation and behavior
- Evaluate for infections before and during treatment
- No contraindications are listed in the FDA label 1
- Safety profile remains consistent with longer exposure, with no increased risk of adverse events over time 4
Missed Doses
If a dose is missed:
- Administer the dose as soon as possible
- Resume dosing at the regularly scheduled interval thereafter 1
Mechanism of Action
Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both IL-17A and IL-17F cytokines, providing a dual mechanism of action that may contribute to its high efficacy 5, 6.
Clinical Pearls
- Rapid onset of action with significant improvement as early as Week 4 6
- Consider the every 4-week maintenance dosing schedule for patients weighing ≥120 kg or those with inadequate response to every 8-week dosing
- The dual inhibition of IL-17A and IL-17F may contribute to the high rates of complete skin clearance observed in clinical trials 5
- Oral candidiasis is more common with bimekizumab than with some other biologics, but is typically mild and rarely leads to discontinuation 4