Is Dupixent (dupilumab) FDA approved for the treatment of bullous pemphigoid?

FDA Approval of Dupixent for Bullous Pemphigoid Treatment

Dupixent (dupilumab) is FDA approved for the treatment of adult patients with bullous pemphigoid (BP). 1

FDA Indication and Dosing

According to the FDA label, Dupixent is specifically indicated for "the treatment of adult patients with bullous pemphigoid (BP)" 1. The recommended dosing regimen for adults with bullous pemphigoid is:

• Initial dose: 600 mg (two 300 mg injections)
• Maintenance dose: 300 mg every 2 weeks

The medication is administered via subcutaneous injection and can be given in the thigh, abdomen (except for the 2 inches around the navel), or upper arm (if administered by a caregiver).

Clinical Evidence Supporting Dupixent Use in BP

Recent clinical evidence strongly supports the efficacy of Dupixent in treating bullous pemphigoid:

• A 2023 multicenter retrospective study of 146 BP patients found that 87% achieved disease control within 4 weeks of starting dupilumab, with a median time to control of 14 days 2
• A 2024 case series of 30 BP patients reported that 76.7% demonstrated either complete clearance of blistering or marked response, and 83.3% had complete clearance of pruritus or marked response 3
• Dupilumab has shown effectiveness as both monotherapy and in combination with corticosteroids, with the combination approach allowing for lower steroid doses and fewer adverse effects 4

Advantages of Dupixent for BP Treatment

Dupixent offers several advantages over traditional BP treatments:

1. Targeted mechanism of action: Dupilumab blocks IL-4 and IL-13 signaling, targeting the type 2 inflammation pathway implicated in BP pathogenesis
2. Favorable safety profile: Much lower rate of adverse effects compared to systemic corticosteroids, which is particularly important in the elderly BP population
3. Rapid response: Most patients show improvement in both blistering and pruritus within 2-4 weeks of treatment initiation
4. Steroid-sparing effect: When used in combination with corticosteroids, allows for lower steroid doses, reducing steroid-related complications

Potential Limitations and Considerations

• Dupixent may be less effective for oral mucosal lesions of BP 4
• Male patients may have a higher relapse rate than female patients 2
• Patients with higher anti-BP180 antibody levels (>50 RU/mL) may respond better to treatment 2
• Common adverse effects include injection site reactions, and some patients may develop eosinophilia or infections 2

Current Research

A Phase 2/3 randomized controlled trial (LIBERTY-BP ADEPT) is currently underway to formally evaluate the efficacy and safety of dupilumab in adults with BP in a double-blind, placebo-controlled setting 5. This study will provide more definitive evidence regarding dupilumab's role in BP treatment.

Conclusion for Clinical Practice

For dermatologists treating bullous pemphigoid, Dupixent represents an FDA-approved, targeted biologic therapy with demonstrated efficacy and a favorable safety profile. It can be considered as either monotherapy in patients who cannot tolerate systemic corticosteroids or as a steroid-sparing agent in combination therapy.