What is the recommended treatment regimen for atopic dermatitis using Belsorma (crisaborole)?

Recommended Treatment Regimen for Atopic Dermatitis Using Belsorma (Crisaborole)

Crisaborole 2% ointment (Belsorma/Staquis) should be applied twice daily to affected areas for the treatment of mild-to-moderate atopic dermatitis in patients aged 3 months and older. 1

Indications and Patient Selection

• Indicated specifically for mild-to-moderate atopic dermatitis
• FDA-approved for patients aged 3 months and older 1, 2
• Serves as an alternative to topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs) 1
• Particularly useful when:
  • TCS use is concerning due to potential side effects
  • Treatment is needed for sensitive areas (face, neck, intertriginous areas)
  • Long-term therapy is required

Application Protocol

• Standard treatment phase:

  • Apply a thin layer of crisaborole 2% ointment to affected areas twice daily 1
  • Continue for 28 days or until lesions clear
  • Maximum treatment area should not exceed 20% of body surface area 1

• Maintenance phase (for preventing flares):

  • Once lesions have cleared or significantly improved, may transition to once-daily application 2
  • Maintenance therapy with once-daily application significantly extends flare-free periods (111 days vs 30 days with vehicle) 2

Efficacy Expectations

• Clinical improvement typically begins within 2 weeks of treatment initiation 1
• After 28 days of twice-daily application:
  • 31-33% of patients achieve clear/almost clear with ≥2-grade improvement 3
  • 48-52% achieve clear or almost clear skin 3
• Significant reduction in pruritus occurs earlier than with vehicle control 3
• Mean change from baseline in lesion itch scores shows 68.6% improvement (vs 54.6% with vehicle) 1

Safety Profile and Side Effects

• Generally well-tolerated with favorable safety profile compared to TCS 4
• Most common side effects:
  • Application site pain/burning/stinging (most frequent adverse event) 1, 5
  • Application site paresthesia 5
• Rare side effects:
  • Potential for drowsiness due to systemic absorption 1
  • Allergic contact dermatitis 1
• Discontinuation rate due to adverse events is low (12.1% vs 2.2% with vehicle) 1

Treatment Algorithm

1. Initial assessment:

   • Confirm diagnosis of mild-to-moderate atopic dermatitis
   • Assess body surface area affected (ideally <20%)

2. Treatment initiation:

   • Apply crisaborole 2% ointment twice daily to all affected areas
   • Reassess after 2 weeks to evaluate response

3. Response evaluation (after 28 days):

   • If clear/almost clear: Transition to maintenance therapy
   • If partial improvement: Continue twice-daily application for additional 2-4 weeks
   • If inadequate response: Consider alternative or adjunctive therapy

4. Maintenance therapy:

   • Apply crisaborole once daily to previously affected areas 2
   • Continue maintenance therapy to prevent flares

5. Flare management:

   • If flare occurs during maintenance: Return to twice-daily application until resolution 2
   • Once flare resolves, resume maintenance regimen

Important Considerations and Pitfalls

• Crisaborole is not for ophthalmic, oral, or intravaginal use 6
• Unlike topical corticosteroids, crisaborole does not cause skin atrophy, making it suitable for long-term use 5
• Crisaborole may be particularly valuable for patients with "steroid phobia" 5
• Not recommended for very severe disease; consider systemic therapy for severe cases 1, 7
• Emollients should be continued as part of the overall management plan 7
• Avoid combining with topical antibiotics for long-term use due to risk of resistance 1

Comparative Efficacy

• Crisaborole shows modest but significant improvement compared to vehicle in clinical trials 1
• While less potent than high-potency TCS, crisaborole has a better safety profile for long-term use 5, 4
• Long-term maintenance with once-daily crisaborole results in fewer flares (mean 0.95 vs 1.36 with vehicle) and more flare-free days (234 vs 199.4 days) 2

By following this treatment regimen with crisaborole, patients with mild-to-moderate atopic dermatitis can experience significant improvement in disease severity and quality of life with minimal risk of adverse effects typically associated with topical corticosteroids.