What is the recommended treatment with biologics, such as adalimumab (tumor necrosis factor-alpha inhibitor), for patients with moderate to severe hidradenitis suppurativa?

Biologic Treatment for Moderate to Severe Hidradenitis Suppurativa

Adalimumab 40 mg weekly is the first-line biologic therapy for patients with moderate to severe hidradenitis suppurativa that is unresponsive to conventional systemic therapy. 1

First-Line Biologic Treatment Algorithm

Initial Assessment

• Confirm diagnosis of moderate to severe hidradenitis suppurativa (Hurley stage II or III)
• Document baseline disease severity using:
  • Hurley staging
  • Inflammatory lesion count
  • Pain scores (VAS)
  • Quality of life measures (DLQI)

Treatment Protocol for Adalimumab

1. Loading dose regimen:

   • 160 mg at week 0 (day 1)
   • 80 mg at week 2
   • 40 mg weekly starting at week 4 1, 2

2. Maintenance dose:

   • 40 mg weekly (not every other week) 1
   • Note: Adalimumab 40 mg every other week is specifically not recommended as it fails to achieve primary efficacy endpoints 1

Evidence Supporting Adalimumab

• Adalimumab is the only FDA-approved biologic for moderate to severe hidradenitis suppurativa in patients 12 years and older 2
• Clinical trials (PIONEER 1 and PIONEER 2) demonstrated significant improvement with weekly dosing:
  • Week 12 HiSCR responses: 42% vs 26% (PIONEER 1) and 59% vs 28% (PIONEER 2) for adalimumab vs placebo 1
• Adalimumab weekly dosing significantly improves:
  • Clinical response (RR 1.76, NNT = 5)
  • Disease severity (modified Sartorius score)
  • Quality of life (DLQI) 3

Monitoring Response

• Evaluate response at 12 weeks using:
  • Inflammatory lesion count
  • Pain scores
  • Quality of life measures 1, 4
• Therapeutic drug monitoring may be beneficial in patients with suboptimal response:
  • Target trough concentration >6 μg/mL
  • Check for anti-adalimumab antibodies (present in 24% of suboptimal responders) 5

Second-Line Biologic Options

• If inadequate response to adalimumab: Consider infliximab 5 mg/kg every 8 weeks 1
• Infliximab should be considered specifically for patients who have failed adalimumab therapy 1

Safety Considerations

• Screen for latent tuberculosis before initiating therapy
• Monitor for:
  • Serious infections
  • Injection site reactions
  • Hepatotoxicity
  • Demyelinating disorders
  • Lupus-like syndrome 4, 6

Special Populations

• Adolescents: Adalimumab is approved for patients 12-17 years of age 1, 2
• Pregnancy: Consider risks and benefits; metformin may be an alternative for pregnant women with HS 1
• Patients with comorbidities: Coordinate biologic therapy with relevant specialists (e.g., oncology for patients with malignancy) 4

Common Pitfalls to Avoid

1. Incorrect dosing: Using adalimumab 40 mg every other week instead of weekly dosing significantly reduces efficacy 1, 3
2. Premature discontinuation: Almost 40% of non-responders at 12 weeks may achieve response by 36 weeks with continued treatment 1
3. Failure to monitor: Not assessing drug levels in patients with suboptimal response 5
4. Inadequate screening: Not screening for latent tuberculosis or other infections before initiating therapy 4

Adalimumab represents a significant advancement in the management of moderate to severe hidradenitis suppurativa, offering improved clinical outcomes and quality of life for patients who have failed conventional systemic therapies.