What is the recommended use and dosage of Otezla (apremilast) for treating plaque psoriasis or psoriatic arthritis?

Otezla (Apremilast) for Plaque Psoriasis and Psoriatic Arthritis

Otezla (apremilast) is recommended at a maintenance dose of 30 mg twice daily for adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for active psoriatic arthritis. 1

Dosing Regimen

Initial Titration (Days 1-5)

The medication requires a 5-day titration schedule to minimize gastrointestinal side effects 1:

• Day 1: 10 mg AM only
• Day 2: 10 mg AM, 10 mg PM
• Day 3: 10 mg AM, 20 mg PM
• Day 4: 20 mg AM, 20 mg PM
• Day 5: 20 mg AM, 30 mg PM
• Day 6 and thereafter: 30 mg AM, 30 mg PM (maintenance dose) 2, 1

Administration Details

• Take orally without regard to meals 1
• Do not crush, split, or chew tablets 1

Dosage Adjustments

Severe Renal Impairment

Reduce to 30 mg once daily in patients with creatinine clearance <30 mL/min. 2, 1 For initial titration in this population, use only the AM schedule and skip all PM doses 1.

Clinical Efficacy

Plaque Psoriasis

• Achieves PASI-75 in approximately 33% of patients at week 16 3
• Efficacy is sustained through week 52, with 61% of patients maintaining PASI-75 response 3
• Effective for difficult-to-treat areas including scalp, nail, and palmoplantar psoriasis 4, 5
• Rapid improvement in pruritus observed as early as week 2 4

Psoriatic Arthritis

• Improves signs and symptoms in both DMARD-naïve and DMARD-experienced patients 4
• Achieves ≥20% improvement in ACR response criteria as early as week 2 4
• Sustained efficacy up to 208 weeks 4

Critical Safety Monitoring

Depression Risk

Discuss the risk of depression with all patients before initiating therapy. 2 Apremilast is associated with emergence or worsening of depression 2. Carefully weigh risks and benefits in patients with history of depression or suicidal ideation 1.

Gastrointestinal Effects

The most common adverse effects are diarrhea (17.3%), nausea (15.7%), upper respiratory tract infections, and headache 2, 5. Patients ≥65 years are particularly prone to dehydration and its complications from severe diarrhea, nausea, or vomiting. 2, 1 Monitor susceptible patients closely and consider dose reduction or suspension if severe GI symptoms develop 1.

Weight Loss

Monitor weight regularly; if >5% weight loss from baseline occurs, consider discontinuing apremilast. 2

Drug Interactions

Do not use apremilast with strong CYP450 inducers (rifampin, phenobarbital, carbamazepine, phenytoin), as this combination results in decreased efficacy. 2 Apremilast is metabolized by cytochrome P450, making it susceptible to these interactions 2.

Laboratory Monitoring

Routine laboratory screening and monitoring can be considered on an individual basis, but is not required. 2 This represents a key advantage over many other systemic therapies 2, 4.

Combination Therapy

There is currently no strong evidence to support combined use of apremilast with other systemic or phototherapy treatments for psoriasis. 2 However, apremilast may be combined with biologics (etanercept, ustekinumab) to augment efficacy in select cases 2. Small studies suggest this combination can be safe in patients not responding adequately to biologics alone 6.

Pregnancy Considerations

Use in pregnancy only if benefit justifies potential risk to fetus. 2

Clinical Positioning

Apremilast is appropriate for patients who prefer oral administration, wish to avoid frequent injections and laboratory monitoring, and are willing to accept slower onset of skin clearance and lower likelihood of complete clearing compared to biologics 2. The ACR/NPF guidelines recommend apremilast as an oral small molecule option, though biologics (TNFi, IL-17i, IL-12/23i) are generally preferred over oral small molecules for treatment-naïve patients with active psoriatic arthritis 2.