What are the recent updates for using Bimikizumab (bimikizumab) for dermatology indications?

Recent Updates for Bimekizumab in Dermatology

Bimekizumab (BIMZELX) received FDA approval in October 2023 for moderate-to-severe plaque psoriasis in adults, with subsequent expansion in November 2024 to include psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa. 1

FDA-Approved Dermatologic Indications

Plaque Psoriasis

• Approved for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy 1
• Dosing: 320 mg subcutaneously at weeks 0,4,8,12, and 16, then every 8 weeks thereafter 1
• For patients weighing ≥120 kg, consider 320 mg every 4 weeks after week 16 due to 30% lower plasma concentrations in this weight category 1

Hidradenitis Suppurativa (HS)

• FDA approval for moderate-to-severe HS was granted in November 2024, representing a major expansion of bimekizumab's dermatologic indications 1
• Dosing: 320 mg subcutaneously at weeks 0,2,4,6,8,10,12,14, and 16, then every 4 weeks thereafter 1
• This more frequent dosing schedule reflects the 31% higher apparent clearance and 18% higher volume of distribution observed in HS patients compared to psoriasis patients 1

Psoriatic Arthritis

• Approved for active psoriatic arthritis in adults (November 2024) 1
• Dosing: 160 mg subcutaneously every 4 weeks 1
• For patients with coexisting moderate-to-severe plaque psoriasis, use the plaque psoriasis dosing regimen (320 mg every 8 weeks after loading) 1

Mechanism of Action and Clinical Differentiation

Bimekizumab is the only IL-17 inhibitor that neutralizes both IL-17A and IL-17F, distinguishing it from secukinumab and ixekizumab (IL-17A only) and brodalumab (IL-17 receptor antagonist). 2, 3, 4

Efficacy Data from Phase III Trials

• In the BE READY trial, 91% of patients achieved PASI 90 at week 16 compared to 1% with placebo, and 93% achieved IGA 0/1 versus 1% with placebo 5
• PASI 100 (complete clearance) was achieved in 47% of patients by week 8 and 57% by week 12 6
• In head-to-head comparisons, bimekizumab demonstrated superior efficacy to secukinumab (BE RADIANT), adalimumab (BE SURE), and ustekinumab (BE VIVID) 2, 3, 4
• Responses were maintained through 56 weeks with both every-4-week and every-8-week maintenance dosing schedules 5

Transcriptomic and Molecular Effects

• Bimekizumab produces profound normalization of the psoriatic transcriptome by week 8, including keratinocyte-related gene products (CXCL1, IL-8, CCL20, IL-36γ, IL-17C) and both IL-17 and IL-23 gene expression 6
• This molecular remission correlates with rapid clinical improvement, with lesional skin transcriptional signatures normalizing to levels consistent with non-lesional skin 6

Safety Profile and Key Warnings

Black Box Warning: Suicidal Ideation and Behavior

• The November 2024 FDA label update added a prominent warning regarding increased risk of suicidal ideation and behavior (SI/B) 1
• Advise patients, caregivers, and families to monitor for emergence or worsening of depression, suicidal ideation, or other mood changes 1
• Instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988 if such changes occur 1
• Carefully weigh risks and benefits in patients with a history of severe depression and/or suicidal ideation or behavior 1

Infection Risk

• May increase risk of infection; instruct patients to seek medical advice if signs or symptoms of clinically important infection occur 1
• Do not administer bimekizumab until active infection resolves 1
• Evaluate for tuberculosis infection prior to treatment initiation; avoid use in active TB and initiate treatment of latent TB before starting bimekizumab 1

Liver Biochemical Abnormalities

• Elevated serum transaminases were reported in clinical trials 1
• Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management 1
• Permanently discontinue bimekizumab in patients with causally-associated combined elevations of transaminases and bilirubin 1

Common Adverse Events

• Oral candidiasis is the most characteristic adverse event, occurring more frequently than with other IL-17 inhibitors due to dual IL-17A/F inhibition 2, 5, 3
• In the initial 16-week treatment period, treatment-emergent adverse events occurred in 61% of bimekizumab-treated patients versus 41% receiving placebo 5
• From weeks 16-56, adverse events occurred in 74-77% of patients on various bimekizumab maintenance regimens versus 69% on placebo 5

Pre-Treatment Requirements

Complete the following assessments before initiating bimekizumab: 1

• Tuberculosis screening (interferon-gamma release assay or tuberculin skin test)
• Baseline liver function tests (transaminases, alkaline phosphatase, bilirubin)
• Complete all age-appropriate vaccinations per current immunization guidelines (live vaccines should be given before treatment initiation)

Immunogenicity

• Anti-drug antibodies (ADA) developed in 45% of psoriasis patients, 47% of psoriatic arthritis patients, and 59% of hidradenitis suppurativa patients during 48-56 weeks of treatment 1
• Neutralizing antibodies were present in 16-25% of patients who developed ADA, depending on indication 1
• No clinically significant effect of anti-bimekizumab antibodies on safety or effectiveness was identified across all pivotal trials 1

Clinical Positioning

Bimekizumab represents a valuable option for patients with moderate-to-severe psoriasis who have failed or are resistant to other biologics, including other IL-17 inhibitors, due to its unique dual IL-17A/F inhibition mechanism. 2, 3

Comparative Advantages

• Faster onset of action compared to other biologics, with significant responses as early as week 4 2
• Higher rates of complete clearance (PASI 100) compared to secukinumab, adalimumab, and ustekinumab 2, 3, 4
• Durable responses maintained with every-8-week dosing after loading phase in psoriasis 5

Important Caveats

• Not approved for pediatric patients; alternative agents with established pediatric safety profiles (etanercept, adalimumab) should be used in patients under 18 years 7
• The psychiatric safety signal requires heightened vigilance, particularly in patients with pre-existing mood disorders 1
• More frequent dosing required for hidradenitis suppurativa (every 4 weeks) compared to psoriasis (every 8 weeks), reflecting different pharmacokinetic profiles 1