Recommended Usage and Dosage of 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 or psoriatic arthritis, following a 5-day titration schedule to minimize gastrointestinal side effects. 1
Indications
- Otezla is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy 1
- Otezla is also indicated for the treatment of adult patients with active psoriatic arthritis 1
Dosing Schedule
Standard Dosing Titration
The recommended 5-day titration schedule is as follows:
- Day 1: 10 mg in the morning
- Day 2: 10 mg in the morning and 10 mg in the evening
- Day 3: 10 mg in the morning and 20 mg in the evening
- Day 4: 20 mg in the morning and 20 mg in the evening
- Day 5: 20 mg in the morning and 30 mg in the evening
- Day 6 and thereafter: 30 mg twice daily (maintenance dose) 1
Special Populations
- For patients with severe renal impairment (creatinine clearance <30 mL/min): reduce dose to 30 mg once daily 1, 2
- For patients with severe renal impairment, use only the morning (AM) schedule during the titration period and skip the evening (PM) doses 1
Administration
Efficacy
Plaque Psoriasis
- In clinical trials, approximately 33% of patients achieved PASI-75 (75% reduction in Psoriasis Area and Severity Index) at week 16 3
- Efficacy is maintained through 52 weeks in patients who continue treatment 3, 4
- Real-world studies suggest potentially higher response rates in patients with lower baseline disease severity 5
Psoriatic Arthritis
- Apremilast improves signs and symptoms in both DMARD-naïve and DMARD-experienced patients with active psoriatic arthritis 6
- Improvements in enthesitis, dactylitis, physical function, and fatigue have been observed 6
- Early onset of efficacy can be seen as early as week 2 6
Special Sites of Psoriasis
- Apremilast is effective for difficult-to-treat areas including nail, scalp, and palmoplantar psoriasis 5
- Significant improvements in pruritus can be seen as early as week 2 6
Monitoring and Safety
Common Adverse Effects
- The most common adverse effects include:
Precautions
- Monitor for depression and suicidal thoughts, especially in patients with a history of depression 1, 2
- Monitor weight regularly; consider discontinuation if weight loss exceeds 5% of baseline 2
- Patients 65 years or older may be at higher risk for complications from severe diarrhea, nausea, or vomiting 1
- Consider dose reduction or suspension if patients develop severe gastrointestinal symptoms 1
Drug Interactions
- Avoid use with strong cytochrome P450 inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) as they may decrease efficacy 2, 1
Laboratory Monitoring
- No routine laboratory monitoring is required 6
- Laboratory screening and monitoring can be considered on an individual basis 2
Combination Therapy
- There is limited evidence supporting the combined use of apremilast with other systemic or phototherapy treatments for psoriasis 2
- In the treatment algorithm for psoriatic arthritis, oral NSAIDs are generally preferred over apremilast as first-line therapy 2
- TNF inhibitor biologics are generally preferred over apremilast for psoriatic arthritis 2
- Small studies suggest apremilast can be safely combined with biologic agents in patients not responding adequately to biologics alone 7
Pregnancy Considerations
- Use during pregnancy only if the benefit justifies the potential risk to the fetus 2
Clinical Pearls
- Apremilast offers the convenience of oral administration without the need for laboratory monitoring 6
- The 5-day titration schedule is designed to reduce gastrointestinal side effects 1
- For patients who prefer oral treatment and are willing to accept a slower onset of skin clearance, apremilast is an appropriate choice 2
- Gastrointestinal side effects typically occur within the first few weeks of treatment and generally improve over time 1