What is the recommended use and dosing regimen for Bimekizumab (Bimekizumab) in patients with moderate to severe plaque psoriasis or active psoriatic arthritis?

Bimekizumab for Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Bimekizumab is recommended for adults with moderate to severe plaque psoriasis at a dose of 320 mg subcutaneously at Weeks 0,4,8,12, and 16, then every 8 weeks thereafter, and for active psoriatic arthritis at 160 mg every 4 weeks. 1

Dosing Regimens

Plaque Psoriasis

• For moderate to severe plaque psoriasis, the FDA-approved dosage is 320 mg by subcutaneous injection at Weeks 0,4,8,12, and 16, then every 8 weeks thereafter 1
• For patients weighing 120 kg or more, consider a dosage of 320 mg every 4 weeks after Week 16 1
• Clinical trials have demonstrated superior efficacy compared to adalimumab and secukinumab in achieving skin clearance 2, 3

Psoriatic Arthritis

• For active psoriatic arthritis, the recommended dosage is 160 mg by subcutaneous injection every 4 weeks 1
• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the plaque psoriasis dosing regimen (320 mg) 1
• In patients with previous inadequate response to TNF-α inhibitors, bimekizumab demonstrated significant improvement with 43% achieving ACR50 at week 16 4

Efficacy Profile

Plaque Psoriasis

• Bimekizumab has demonstrated superior efficacy compared to other biologics:
  • 86.2% of patients achieved PASI 90 with bimekizumab vs. 47.2% with adalimumab at week 16 2
  • 61.7% of patients achieved complete skin clearance (PASI 100) with bimekizumab vs. 48.9% with secukinumab at week 16 3
• Network meta-analysis shows bimekizumab has the highest probability of achieving PASI 75 (92.3%), PASI 90 (84.0%), and PASI 100 (57.8%) among all biologics at 10-16 weeks 5

Psoriatic Arthritis

• In TNF-α inhibitor inadequate responders, bimekizumab showed significant improvement with:
  • 43% achieving ACR50 at week 16 compared to 7% with placebo 4
  • 69% of patients with psoriasis (≥3% BSA) achieved PASI 90 compared to 7% with placebo 4

Special Populations and Considerations

Evaluation Prior to Treatment

• Evaluate patients for tuberculosis infection prior to initiating treatment 1
• Test liver enzymes, alkaline phosphatase, and bilirubin before starting therapy 1
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines 1

Administration Guidelines

• Bimekizumab is intended for use under healthcare professional guidance, but patients may self-inject after proper training 1
• If two separate 160 mg injections are needed, administer at different anatomic locations 1
• Allow medication to reach room temperature (30-45 minutes) before injection 1

Safety Profile and Monitoring

Common Adverse Events

• Upper respiratory tract infections 2, 3
• Oral candidiasis (predominantly mild or moderate) - more common with bimekizumab (19.3%) than with secukinumab (3.0%) 3
• Hypertension and diarrhea 2

Important Safety Considerations

• Monitor for suicidal ideation and behavior as an increased incidence has been observed in clinical trials 1
• No contraindications are listed in the FDA label 1
• The safety profile is consistent with other IL-17 inhibitors 4

Comparative Efficacy with Other Biologics

• Bimekizumab demonstrated superior efficacy to adalimumab in plaque psoriasis with 86.2% vs 47.2% achieving PASI 90 at week 16 2
• Bimekizumab was superior to secukinumab with 61.7% vs 48.9% achieving PASI 100 at week 16 3
• Network meta-analysis showed bimekizumab has statistical superiority over all biologics in achieving PASI 90 and PASI 100 thresholds 5
• Dual inhibition of IL-17A and IL-17F by bimekizumab results in rapid, deep clinical responses and profound normalization of the psoriatic transcriptome 6

Clinical Pearls

• Bimekizumab's unique mechanism as a dual inhibitor of IL-17A and IL-17F contributes to its high efficacy 2, 3, 6
• Rapid onset of action with 71.0% of patients achieving PASI 75 by week 4 (vs 47.3% with secukinumab) 3
• Consider the higher risk of oral candidiasis compared to other biologics when selecting therapy 3
• For patients with both psoriatic arthritis and moderate-to-severe plaque psoriasis, use the plaque psoriasis dosing regimen 1