4CPS-035 Persistence and safety of apremilast in psoriasis

Background Psoriasis is a disease that requires long-term treatment. Apremilast is indicated in the treatment of psoriasis in patients who have not responded or have contraindicated or cannot tolerate other treatment systemics. This drug has a lower accumulated specific organ toxicity, so it seems that it is the first oral systemic drug with which long-term treatments can be planned. Purpose To estimate the persistence and safety of treatment with apremilast in patients diagnosed with psoriasis. Material and methods Retrospective observational study of all patients with psoriasis who were treated with apremilast (January 2016 to September 2018). Demographic variables (age, sex) and variables related to the drug were collected (treatment start and discontinuation date, adverse reactions, causes of suspension and previous treatment). Persistence was defined as time (months) from the start of treatment until its discontinuation due to toxicity or inefficiency. Persistence was calculated with Kaplan–Meier survival curves (log rank test). Results Forty-two patients (54.8% women) were included. Mean age was 46.5 years (SD=13,2). Previous therapies: topical (100%), methotrexate (38.1%), acycretin (30.9%), cyclosporin (23.8%) and etanercept (7.2%). Average of previous treatments/patient: 2 (1–3). Mean persistence was 19.4 months (95% CI 14.9 to 23.9). At the end of the study period, 69% (n=29) of patients continued with apremilast and 31% (n=13) were discontinued. The causes of suspension were inefficacy in 62% (n=8) and toxicity in 38% (n=5). The severe adverse reactions that required the suspension of treatment were: diarrhoea (one), migraine (one), low back pain (one) and psychiatric disorder (two). Two patients required dose reduction (30 mg/24 hour). The estimated median time of treatment until discontinuation due to toxicity is 3 months compared to 4 months for patients who leave treatment due to inefficiency. There are no statistically significant differences between the survival curves of the causes of abandonment of treatment with apremilast (p=0.532). After 15 months of treatment the probability of discontinuing treatment for any of the causes is maintained over time. Conclusion The role of the pharmacist is essential in detecting the symptoms and signs of toxicity and ineffectiveness in the first year of treatment. Even so it would be of interest to extend the study time to analyse the long-term persistence. References and/or acknowledgements No conflict of interest.