e62 Audit of apremilast for psoriatic arthritis: experience from an 18-month local patient access scheme

Abstract

Background: Supported by data from the PALACE trials, apremilast was licensed by the European Medicine Agency in January 2015 for treatment of psoriatic arthritis (PsA). However, it only received NICE approval in February 2017. A patient access scheme was implemented to provide apremilast to PsA patients under Medway Maritime Hospital (MMH) for no drug cost from October 2015.This audit aimed to investigate if the existing use of apremilast was compatible with NICE recommendations, and whether our practice reproduced the safety and efficacy results of the clinical trials. Method(s): Audit criteria (Table 1) were informed by NICE guidance and the PALACE trials. Patients prescribed apremilast by rheumatologists in MMH were identified from drug company's supply records. Review of clinic letters and case notes was undertaken. Result(s): Fifteen patients were identified, but two did not commence apremilast after the drug was supplied. Therefore 13 patients were initiated on apremilast between October 2015 and March 2017. Our result is presented in Table 1. Six patients discontinued apremilast. Side effects contributed to discontinuation in five patients. In the whole cohort, the most common reported side effects were gastrointestinal (7), headache (2), and mood change (2). Inefficacy contributed to discontinuation in three patients, of whom two patients had previous therapeutic failures with more than one anti-TNF agents. Conclusion(s): Apremilast discontinuation rate in this cohort was higher than that in clinical trials. The PALACE studies reported GI disturbance as an early side effect which improved over time. Therefore, additional education for patients may improve drug survival. Patients on apremilast were assessed for efficacy before the recommended 16 weeks. Compared to anti-TNF agents, the apremilast has a slower onset of efficacy. Therefore, early assessment of efficacy could have led to premature discontinuation for presumed inefficacy. An apremilast pathway that is distinct from the existing biologics pathway should be implemented with appropriate follow up interval.