Proper Use and Dosage of Otezla (Apremilast) for Treating Psoriasis
Otezla (apremilast) should be initiated with a 5-day titration schedule starting at 10 mg once daily and increasing to the maintenance dose of 30 mg twice daily by day 6 to reduce gastrointestinal side effects. 1, 2
Dosing Schedule
Initial titration schedule (to reduce gastrointestinal side effects) 1, 2:
- Day 1: 10 mg in the morning
- Day 2: 10 mg in the morning and evening
- Day 3: 10 mg in the morning, 20 mg in the evening
- Day 4: 20 mg in the morning and evening
- Day 5: 20 mg in the morning, 30 mg in the evening
- Day 6 and thereafter: 30 mg twice daily (maintenance dose)
Otezla can be taken with or without food 2
Tablets should not be crushed, split, or chewed 2
Dosage Adjustments
- For patients with severe renal impairment (creatinine clearance <30 mL/min), reduce dosage to 30 mg once daily 1, 2
- For patients with severe renal impairment, use only the morning doses during the titration period 2
- No dosage adjustment is required for mild to moderate renal impairment 1
- No dosage adjustment is required for hepatic impairment 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 2
- Particularly appropriate for patients who prefer oral administration and wish to avoid laboratory monitoring 1
- Can be used in patients with complex medical issues where other systemic agents may be contraindicated 1
Efficacy
- In clinical trials, 33.1% of patients achieved PASI-75 (75% improvement in Psoriasis Area and Severity Index) at week 16 3
- Efficacy is maintained with continued use, with 61% of patients achieving PASI-75 at week 52 with continuous treatment 3
- Apremilast 30 mg twice daily demonstrated significantly greater efficacy compared to 10 mg twice daily or 20 mg once daily regimens 4, 5
- Improvements in difficult-to-treat areas including nail, scalp, and palmoplantar psoriasis have been reported 6
Common Side Effects and Management
Gastrointestinal effects (most common) 1, 2:
- Diarrhea, nausea, and vomiting typically occur within the first 2 weeks of treatment
- 70-80% of GI side effects are mild in severity
- 60-65% resolve within the first month
- Severe cases may require dose reduction or suspension, especially in elderly patients or those at risk of dehydration
Other common side effects 1, 7:
- Upper respiratory tract infections
- Headache
- Weight loss (5-10% of body weight in 12% of patients)
- Depression (approximately 1% of patients)
Monitoring Requirements
- No routine laboratory monitoring is required 1, 6
- Regular weight monitoring is recommended 1
- Consider discontinuation if weight loss exceeds 5% from baseline 1
- Monitor for signs of depression or suicidal thoughts, especially in patients with a history of depression 1, 2
Contraindications and Precautions
- Contraindicated in patients with known hypersensitivity to apremilast or any excipients 2
- Use with caution in patients with a history of depression 1, 2
- Not recommended for use with strong cytochrome P450 inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) as they may decrease efficacy 1
- Patients prone to dehydration (especially elderly) should be monitored closely due to risk of complications from GI side effects 1
- Limited data on use in pregnancy; use only if benefit justifies potential risk to fetus 1
Clinical Pearls
- Proper patient counseling before initiating therapy can improve adherence and reduce discontinuation rates 1, 7
- Inform patients about potential GI side effects and that they typically improve within the first month 1
- The dose titration schedule is essential for minimizing GI side effects 1, 2
- There is currently no strong evidence supporting the combined use of apremilast with other systemic treatments or phototherapy for psoriasis 1
- Apremilast offers the advantage of not requiring laboratory monitoring, unlike many other systemic psoriasis treatments 1, 6