The most common observed distinctive side effect is diarrhea, seen in roughly 8% to 15% of patients. Other side effects include nausea, vomiting, weight loss, headache and upper respiratory tract infection. More rare side effects include gastroesophageal reflux disease, hypersensitivity, migraine and suicidal ideation. In order to decrease the risk of diarrhea and other common side effects, gradual dose increase is recommended. No cases of tuberculosis or lymphoma were reported through week 16. There was no apparent increased risk of serious opportunistic infection. In case of severe side effects, discontinuation of therapy should be considered. Although the side effects are not as severe as the potential side effects of methotrexate, they could have the potential to reduce patients’ adherence. Common side effects of apremilast tend to fade over time and mostly resolve after 15 days of treatment, so efforts should be made to encourage patients to develop a habit of taking this medication through this period and beyond. Due to lack of studies in pregnant women, apremilast is considered Pregnancy Category C. Apremilast should only be used in pregnant or breastfeeding women if the potentialbenefit justifies the potential risk.
Weight monitoring is recommended as modest weight loss is seen in some patients (something many patients might consider a benefit of the drug). Discontinuation of therapy should be considered in case of significant weight loss. Renal function should also be assessed. Patients should be monitored for mood changes, depression and suicidal thoughts during therapy (Table 2).
Tips and Tricks
1. Use the start-up packs to help minimize the risk of diarrhea. Developing diarrhea late in therapy is unusual.
2. Adherence is usually worse in clinical practice than in clinical studies. That could limit the effectiveness of apremilast, which is not the most effective drug to begin with. Help patients develop a plan to assure good adherence.
3. If patients are worried about the drug, let them know that caffeine is also a PDE inhibitor.
4. Apremilast should only be used in pregnant or breastfeeding women if the potential benefit justifies the potential risk.
5. Some patients may find the possible weight loss side effect to be a positive attribute about the drug.
6. Consider dosage reduction in patients with severe renal impairment (creatinine clearance <30 mL/minute).
7. No laboratory monitoring is required for patients on apremilast.
This article is an excerpt from the book, Practical Psoriasis Management. Dr. Moradi Tuchayi is a postdoc fellow at Massachusetts General Hospital in Boston, MA.
Disclosure: The author reports no relevant financial relationships.
1. Signorovitch JE, Betts KA, Yan YS, et al. Comparative efficacy of biological treatments for moderate-to-severe psoriasis: a network meta-analysis ad- justing for cross-trial differences in reference arm response. Br J Dermatol. 2015;172(2):504-512