What is Otezla (apremilast) prescribed for in patients with moderate to severe plaque psoriasis, including lesions on hands, arms, and face?

Otezla (Apremilast) for Moderate to Severe Plaque Psoriasis

Otezla (apremilast) is specifically FDA-approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, including those with lesions on hands, arms, and face. 1

Mechanism and Positioning in Treatment Algorithm

Apremilast is an oral phosphodiesterase 4 (PDE4) inhibitor that works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production involved in psoriasis 2. In the treatment algorithm for psoriasis:

1. First-line treatments (should be tried before Otezla):

   • Topical therapies
   • Phototherapy (narrowband UVB)
   • Traditional systemic agents (methotrexate, cyclosporine, acitretin) 3

2. Otezla positioning:

   • Second-line or later therapy after failure of or contraindication to first-line options
   • Particularly useful for patients with lesions in visible areas (face, hands, arms) where quality of life is significantly impacted

Dosing and Administration

• Initial titration (to reduce gastrointestinal side effects) 1:

  Day 1	Day 2	Day 3	Day 4	Day 5	Day 6+
  10mg AM	10mg AM/PM	10mg AM, 20mg PM	20mg AM/PM	20mg AM, 30mg PM	30mg AM/PM

• Maintenance dose: 30mg twice daily 1

• Renal adjustment: For severe renal impairment (CrCl <30 mL/min), reduce to 30mg once daily 1

• Can be taken without regard to meals; do not crush, split or chew tablets 1

Clinical Efficacy for Plaque Psoriasis

Apremilast has demonstrated efficacy in multiple clinical trials:

• ESTEEM 1 trial: 33.1% of patients achieved PASI-75 (75% reduction in Psoriasis Area and Severity Index) at week 16 vs. 5.3% with placebo 4
• ESTEEM 2 trial: 28.8% achieved PASI-75 at week 16 vs. 5.8% with placebo 5
• Phase 2b trial: PASI-75 was achieved by 29% of patients on 20mg twice daily and 41% on 30mg twice daily vs. 6% on placebo at week 16 6

Efficacy for Special Areas (Hands, Arms, Face)

Apremilast has shown effectiveness for difficult-to-treat areas:

• Effective for visible areas including face, hands, and arms
• Can be used for plaque psoriasis affecting the scalp 7
• May be combined with topical treatments to enhance efficacy for resistant areas 7

Safety Profile and Monitoring

• Common adverse events (generally mild to moderate) 4, 5:

  • Gastrointestinal: nausea, diarrhea, vomiting
  • Upper respiratory tract infection
  • Headache

• Important warnings:

  • Monitor for severe diarrhea, nausea, and vomiting, especially in first few weeks
  • Patients ≥65 years or on medications causing volume depletion may be at higher risk for complications 1
  • Consider dose reduction or suspension for severe gastrointestinal symptoms 1

• Advantages over other systemic therapies:

  • No laboratory monitoring required
  • No significant drug interactions
  • Oral administration (versus injectable biologics)
  • No increased risk of infections or malignancy

Combination Therapy Options

Apremilast may be combined with other treatments to enhance efficacy:

• Can be combined with topical corticosteroids or vitamin D analogs 7
• May be combined with etanercept (strength of recommendation C) 7
• May be combined with ustekinumab (strength of recommendation C) 7
• Can be combined with narrowband UVB phototherapy 7

Time to Response Assessment

• Evaluate response after 16 weeks of continuous therapy 4, 6, 5
• If inadequate response after 16 weeks, consider alternative therapy

Clinical Pearls and Pitfalls

• Pearls:

  • Gradually titrate dose to minimize gastrointestinal side effects
  • Efficacy may continue to improve beyond 16 weeks
  • No laboratory monitoring required, making it convenient for patients

• Pitfalls to avoid:

  • Not following the dose titration schedule (increases risk of GI side effects)
  • Discontinuing too early (full effect may take 16 weeks)
  • Using as first-line therapy when guidelines recommend traditional systemics or phototherapy first
  • Not considering combination with topicals for enhanced efficacy

Apremilast offers a valuable oral option with a favorable safety profile for patients with moderate to severe plaque psoriasis, particularly for those with lesions in visible areas like hands, arms, and face, who have failed or cannot use first-line therapies.