Background and importance Apremilast is indicated for the treatment of psoriatic arthritis (PA) alone or in combination with disease-modifying antirheumatic drugs (DMARD), and the treatment of moderate to severe plaque psoriasis (PP) in adult patients who failed to respond or have a contraindication, or are intolerant to DMARD or other systemic therapy, including biological.
According to the European Medicines Agency (EMA), reasons for discontinuation are the lack of response at 24 weeks, diarrhoea and nausea.
Aim and objectives The aim of the study was to assess the effectiveness and safety of apremilast in patients with PA or PP.
Material and methods Retrospective study performed in a third-level hospital. Patients who started apremilast between June 2016 and February 2021 were included, and their evolution was followed until August 2021. Demographic, clinical and treatment variables at baseline were collected. Efficacy and safety were analysed based on the general subjective assessment of the physician.
Data were obtained from medical records. Analysis was performed using Microsoft Excel.
Results A total of 47 patients were selected (38 PP and 9 PA). PP patients (13 women, median age 53.5 (22–82) years), 16 had received prior non-biological systemic treatment, 11 biological, 9 topical and 2 phototherapy. PA patients (6 women, median age 46 (28–70) years), 8 had received DMARD and 1 biological.
Apremilast was effective in 24 patients (19 PP and 5 PA) at 6 months. In PP, 8 achieved total whitening and 11 partial. In PA, 4 achieved a moderate disappearance of pain and 1 mild. 7 patients discontinued before 6 months due to adverse effects (AE), it not being possible to determine the response.
At the end of follow-up, 8 patients (7 PP and 1 PA) continued with apremilast, with a median of 21 (8.6–30.9) months. The drug was discontinued in 31 PP patients after a median of 3.4 (0.5–24.8) months (12 lack of response (LR), 11 loss of efficacy (LE), 3 vomiting, 2 diarrhoea, 1 headache and 1 death) and 8 PA patients after a median of 6.2 (3.7–10.8) months (4 LR, 3 LE and 1 diarrhoea).
Conclusion and relevance Apremilast has been effective in half of the patients at 6 months, but less than a quarter remain on treatment.
Regarding the safety profile, 8 patients discontinued due to AE, the gastrointestinal AE being the most common.
Conflict of interest No conflict of interest