What routine laboratory tests are recommended for patients taking Otezla (apremilast)?

Routine Laboratory Monitoring for Otezla (Apremilast)

No routine laboratory monitoring is required for patients taking Otezla (apremilast). 1

Key Monitoring Recommendations

Laboratory Testing

• Baseline labs: Routine laboratory screening can be considered on an individual basis, but is not mandated by guidelines 1
• Ongoing monitoring: No periodic blood work is required during treatment 1, 2, 3
• Renal function consideration: For patients with severe renal impairment (creatinine clearance <30 mL/min), baseline assessment is prudent to guide dose adjustment, though not explicitly required 1

This represents a major advantage of apremilast compared to other systemic psoriasis therapies like methotrexate, which require regular monitoring of complete blood counts, liver enzymes, and renal function 1, 2

Clinical Monitoring Parameters

Weight monitoring is the single most important clinical parameter to track:

• Monitor body weight regularly at each visit 1
• If weight loss exceeds 5% from baseline, strongly consider discontinuing apremilast 1
• Weight loss of 5-10% occurs in approximately 12% of patients on apremilast versus 5% on placebo 1

Depression screening should be performed:

• Discuss the risk of depression with patients before initiating therapy 1
• Monitor for emergence or worsening of depression at each visit 1
• Depression occurs in approximately 1% of patients 2

Gastrointestinal symptoms require clinical attention:

• Assess for diarrhea, nausea, and vomiting at follow-up visits 1, 4
• These symptoms occur in 70-80% of patients within the first 2 weeks, with 75-80% being mild and 60-65% resolving within the first month 2
• Elderly patients are particularly prone to dehydration from GI effects and may require hospitalization 1

Why No Laboratory Monitoring Is Needed

Hepatic Safety Profile

• Despite hepatic metabolism via cytochrome P450, apremilast does not cause hepatotoxicity 2
• Liver injury is not listed among apremilast's adverse effects in American Academy of Dermatology guidelines 2
• No hepatic dose adjustment is required (unlike methotrexate or other systemic agents) 2

Hematologic Safety

• Apremilast does not cause bone marrow suppression or blood count abnormalities 1, 2
• This contrasts sharply with methotrexate, which requires CBC monitoring every 3-4 months 1

Renal Considerations

• The only renal-related requirement is dose reduction (not monitoring) for severe impairment 1, 2
• Reduce dose to 30 mg once daily (instead of twice daily) if creatinine clearance is <30 mL/min 1

Clinical Implications

Apremilast is particularly advantageous for:

• Patients with pre-existing liver disease who cannot tolerate methotrexate 2
• Patients with complex medical comorbidities requiring multiple medications 2
• Patients who cannot undergo regular laboratory monitoring due to access barriers, needle phobia, or other reasons 1, 2, 3
• Patients who prefer to avoid the inconvenience and cost of frequent blood draws 3

Common Pitfalls to Avoid

• Do not order routine labs "just to be safe" – this adds unnecessary cost and patient burden without clinical benefit 1, 2
• Do not forget to monitor weight – this is the one objective parameter that requires tracking and can necessitate drug discontinuation 1
• Do not overlook depression screening – while laboratory monitoring isn't needed, clinical monitoring for mood changes is essential 1
• Do not ignore medication interactions – review the medication list for strong CYP450 inducers (rifampin, phenobarbital, carbamazepine, phenytoin) which reduce apremilast efficacy 1