Managing Apremilast-Induced Gastritis
Apremilast does not cause gastritis; it causes gastrointestinal symptoms (diarrhea, nausea, vomiting) that are typically self-limited and resolve within the first month without intervention. 1, 2
Understanding the GI Side Effects
The gastrointestinal symptoms associated with apremilast are not inflammatory gastritis but rather functional GI disturbances related to PDE4 inhibition:
- 70-80% of GI adverse effects occur within the first 2 weeks of treatment 1
- 75-80% are mild in severity 1
- 60-65% resolve within the first month with continued dosing and without intervention 1
- The most common symptoms are diarrhea and nausea, not gastritis 1, 2
Initial Management Strategy
Continue Current Therapy
Most patients should continue apremilast without dose modification, as symptoms typically resolve spontaneously within 4 weeks 1, 3, 4:
- Reassure the patient that symptoms are expected and usually temporary 3
- Ensure proper hydration, especially in elderly patients who are at higher risk for dehydration-related complications 1, 2
- Monitor for severe symptoms that might require hospitalization 2
Symptomatic Treatment
Provide supportive care while waiting for spontaneous resolution 3:
- Anti-diarrheal agents (e.g., loperamide) for diarrhea
- Anti-emetics for nausea
- Small, frequent meals to minimize GI distress
- Adequate fluid intake to prevent dehydration 2
When to Reduce or Discontinue
Dose Reduction
Consider reducing the dose to 30 mg once daily if symptoms are moderate but tolerable 2:
- This approach is supported by the FDA label for managing severe GI symptoms 2
- Patients generally improve quickly with dose reduction 2
Discontinuation Criteria
Discontinue apremilast if 2, 4:
- Severe diarrhea, nausea, or vomiting develops that does not improve with supportive care 2
- Chronic diarrhea persists beyond 4 weeks leading to malnutrition 4
- Hospitalization is required for GI complications 2
- The patient is elderly or taking medications causing volume depletion, making them more susceptible to complications 2
Special Populations at Higher Risk
Elderly patients (≥65 years) require closer monitoring 1, 2:
- They are more prone to dehydration from GI effects 1
- Higher risk of hospitalization from severe diarrhea, nausea, or vomiting 2
- Consider more aggressive supportive care and earlier intervention 2
Patients on medications causing volume depletion or hypotension 2:
- Monitor more frequently for complications
- Ensure adequate hydration
- Consider prophylactic anti-diarrheal agents
Common Pitfalls to Avoid
- Do not prematurely discontinue apremilast for mild-to-moderate GI symptoms in the first 2-4 weeks, as most resolve spontaneously 1, 3
- Do not confuse functional GI symptoms with gastritis—apremilast does not cause inflammatory gastric disease 1, 2
- Do not forget the mandatory 5-day titration schedule when initiating therapy, as this reduces GI symptoms 1, 2
- Do not ignore severe symptoms in elderly patients, as they may require hospitalization 2
Alternative Approach: Combination Therapy
If GI symptoms are intolerable but the patient is responding well to apremilast for their psoriasis/psoriatic arthritis, consider adding apremilast to a biologic agent rather than using it as monotherapy 5: