Apremilast in psoriasis – a prospective real‐world study

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Apremilast is a novel oral phosphodiesterase‐4 inhibitor approved for psoriasis treatment. Randomized trials have documented its efficacy and safety, but data on real‐world patients are scarce.</jats:p></jats:sec><jats:sec><jats:title>Objectives</jats:title><jats:p>We aim to characterize psoriasis patients treated with apremilast in a real‐world setting and calculate drug survival as an important measure of efficacy and compliance.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>All patients with psoriasis who received apremilast between 1 April 2015 and 19 January 2017 were evaluated every 4 weeks, and we documented: age, weight, height, smoking status, family history of psoriasis, joint involvement, previous treatments, psoriasis area severity index (<jats:styled-content style="fixed-case">PASI</jats:styled-content>) scores, and the onset and duration of adverse events (<jats:styled-content style="fixed-case">AE</jats:styled-content>). Efficacy was analysed by <jats:styled-content style="fixed-case">PASI</jats:styled-content>50, <jats:styled-content style="fixed-case">PASI</jats:styled-content>75 and <jats:styled-content style="fixed-case">PASI</jats:styled-content>90, reflecting the improvement of skin lesions compared to the <jats:styled-content style="fixed-case">PASI</jats:styled-content>‐baseline. Kaplan–Meier statistics were used for drug survival estimates.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Forty‐eight patients were included. The median apremilast drug survival was 12.5 weeks (range 1–87). Three patients (6.3%) reached <jats:styled-content style="fixed-case">PASI</jats:styled-content>90, nine (18.8%) PASI75 and eight patients (16.7%) <jats:styled-content style="fixed-case">PASI</jats:styled-content>50. Patient weight inversely correlated with a <jats:styled-content style="fixed-case">PASI</jats:styled-content>50 response (<jats:italic>P</jats:italic> < 0.05, <jats:italic>n</jats:italic> = 37), and none of the obese patients (<jats:styled-content style="fixed-case">BMI</jats:styled-content> > 30.0, <jats:italic>n</jats:italic> = 6) reached <jats:styled-content style="fixed-case">PASI</jats:styled-content>75, compared to 32% of the non‐obese patients (<jats:styled-content style="fixed-case">BMI</jats:styled-content> < 30.0, <jats:italic>n</jats:italic> = 31). Thirty‐one patients (64.6%) reported at least one <jats:styled-content style="fixed-case">AE</jats:styled-content>, most frequently diarrhoea (<jats:italic>n</jats:italic> = 21, 43.8%), headache (<jats:italic>n</jats:italic> = 7, 14.6%) and joint pain (<jats:italic>n</jats:italic> = 5, 10.4%).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Despite differences between real‐world and trial patients, apremilast is safe and effective for the treatment of skin psoriasis in the daily practice. Up to 40% of patients will reach <jats:styled-content style="fixed-case">PASI</jats:styled-content>50 or higher, but only few patients will reach <jats:styled-content style="fixed-case">PASI</jats:styled-content>90. Bodyweight might affect drug efficacy.</jats:p></jats:sec>