Post-marketing suicide-related events subsequent to apremilast exposure

Introduction Apremilast is approved for psoriasis and psoriatic arthritis in adults. Of concern, suicide-related events (SRE) are described in the Full Prescribing Information (FPI) and have been reported in postmarketing experience. The aim of this study was to explore the post-marketing frequency of SRE (suicide, suicide attempts, suicidal behavior, and suicidal ideation) subsequent to apremilast exposure. Methods Three large databases were searched: 1)A large U.S. patient population (NMEDW, > 4 million patients) was searched for adults (18-89 years) exposed to apremilast (between January 2014 through November 2016), and had a subsequent SRE; 2) The US Food and Drug Administration Adverse Event Reporting System (FAERS); and 3) The European Medicines Agency (EudraVigilance) were also searched for the same SREs. Results Of 262 apremilast-exposed NMEDW patients, only 1 had a documented SRE (suicidal ideation) post apremilast exposure. In EudraVigilance, there were 85 SREs, and 131 reports were detected in FAERS. Notably, a safety signal (defined as number of events >3, chi-square >4, PRR >2) was not detectable within FAERS (PRR=0.62). Conclusions These findings, nearly two years post-marketing, remain consistent with pre-marketing data and as described in the apremilast Full Prescribing Information. However, considering risk-to-benefit, ongoing pharmacovigilance remains warranted.