When to Prefer Bimekizumab Over Adalimumab in Treatment-Naïve Hidradenitis Suppurativa
Bimekizumab should not be preferred over adalimumab as first-line biologic therapy in treatment-naïve patients with moderate-to-severe hidradenitis suppurativa, as adalimumab remains the guideline-recommended first-line biologic with FDA approval, established long-term safety data, and a well-defined benefit-risk profile. 1, 2
Guideline-Based Treatment Algorithm
First-Line Biologic Therapy
Adalimumab is the only FDA-approved biologic for hidradenitis suppurativa and is recommended as first-line biologic therapy by the American Academy of Dermatology, British Association of Dermatologists, and European guidelines for patients with moderate-to-severe disease unresponsive to oral antibiotics. 1, 2
The standard adalimumab regimen is 160 mg at week 0,80 mg at week 2, then 40 mg weekly starting at week 4. 1, 2, 3
Adalimumab demonstrates HiSCR response rates of 42-59% at week 12 compared to 26-28% with placebo, with a favorable number needed to treat (NNT) of 4 and number needed to harm (NNH) of 26 for serious adverse events. 2
When Bimekizumab May Be Considered
Bimekizumab should be reserved for patients who have failed adalimumab therapy, not as a first-line option in treatment-naïve patients. However, specific clinical scenarios where bimekizumab might be considered earlier include:
After Adalimumab Failure
Bimekizumab demonstrated HiSCR50 response rates of 48-52% at week 16 (every 2 weeks dosing) versus 29-32% with placebo in the BE HEARD I and II trials. 4
Responses were maintained or increased through week 48, suggesting durable efficacy. 4
The key distinction is that bimekizumab targets IL-17A and IL-17F, offering a different mechanism than TNF-alpha inhibition, which may benefit patients who have inadequate response to adalimumab. 4, 5
Potential Earlier Use Scenarios (Not Guideline-Supported)
While not currently recommended by guidelines, theoretical scenarios where bimekizumab might be considered earlier include:
Patients with documented contraindications to TNF-alpha inhibitors (active tuberculosis, demyelinating disease, congestive heart failure). 1
Patients with concurrent inflammatory bowel disease who have failed TNF-alpha inhibitors for their IBD, though this remains off-guideline. 1
Critical Treatment Considerations
Monitoring and Response Assessment
Assess treatment response at 12 weeks using HiSCR (≥50% reduction in abscess and inflammatory nodule count with no increase in abscess or draining tunnel count). 1, 2, 3
Measure quality of life using DLQI and pain using Visual Analog Scale. 1, 2, 3
Approximately 40% of adalimumab non-responders at 12 weeks achieve response by week 36 with continued treatment, so premature discontinuation should be avoided. 1, 2
Common Pitfalls to Avoid
Do not use adalimumab 40 mg every other week dosing for moderate-to-severe hidradenitis suppurativa, as this regimen failed to meet efficacy endpoints in clinical trials. 1
Do not discontinue adalimumab before 16 weeks unless there are safety concerns, as delayed responders are common. 2
Nearly half of week 12 adalimumab responders lose response by week 36 despite continued weekly dosing, necessitating close monitoring and potential dose optimization or switch to alternative biologics. 1, 2
Safety Profile Comparison
Adalimumab has extensive long-term safety data across multiple indications with well-characterized risks (infections, malignancy, injection site reactions). 1, 2
Bimekizumab's most frequent adverse events include hidradenitis flares, upper respiratory infections, oral candidiasis, headache, and diarrhea, with one death reported (congestive heart failure, deemed unrelated to treatment). 4
Bimekizumab causes more frequent candida infections and eczematous reactions compared to TNF-alpha inhibitors, which should be considered in patient selection. 5
Evidence Quality and Limitations
The recommendation to use adalimumab first is based on:
- Multiple phase 3 trials (PIONEER 1 and 2) establishing efficacy and safety 1, 2
- FDA approval specifically for hidradenitis suppurativa 1, 2
- Inclusion in all major international guidelines as first-line biologic therapy 1, 3
Bimekizumab, while showing promising efficacy in BE HEARD I and II trials, lacks:
- Guideline incorporation as first-line therapy (guidelines predate its approval) 1
- Long-term safety data beyond 48 weeks in hidradenitis suppurativa 4
- Head-to-head comparison trials with adalimumab 4
The current evidence strongly supports adalimumab as the initial biologic choice, with bimekizumab reserved for adalimumab failures or specific contraindications to TNF-alpha inhibition. 1, 2, 4