Skin involvement in patients with psoriatic arthritis: preliminary results of treatment with apremilast in real world setting.

BACKGROUND: Apremilast is a "small molecule", an oral phosphodiesterase 4 inhibitor indicated for the twice- daily treatment of adults with psoriasis (PsO) and psoriatic arthritis (PsA). Data concerning clinical experience in real world setting with Apremilast for psoriasis are still exiguous, and aim of this report is to provide our experience in the use of Apremilast in out-patient setting.

METHODS: Ten caucasian individuals (6 male, 4 females; mean age 69,3; range 53-81 years) affected by moderate to severe plaque psoriasis (PASI≥10 e/o DLQI≥10 e/O BSA≥10) were treated with Apremilast, following dosing regimen of technical data sheet and clinically evaluated both after 12 weeks (T12) and 16 weeks (T16). At baseline median PASI was 14 (range 10 - 25, SD 5.0). The median BSA was 17,55 (10 - 25, SD 6.0), the median PGA was 3.5 (2 - 5, SD 1.1), the median DLQI was 7,3 (5 - 18, SD 3.6). The median absolute value of PASI, BSA, PGA and DLQI showed a statistically significant decrease (p<0.05) already after 12 weeks of treatment.

RESULTS: At T12, 6 patients out from 10 (60%) reached PASI 50 and 3/10 patients (30%) reached PASI 75. At T16, 9 patients out from 10 patients (9/10, 90%) reached PASI75, and 3/10 (30%) reached PASI90. Five patients out from 10 (50%) reached MDA at T16. Diarrhoea was the main side effect occurring during the first weeks of treatment, that resolved spontaneously over the time.

CONCLUSIONS: Although our preliminary results need to be confirmed by further larger observational studies, seem to confirm the efficacy and safety profile provided through the ESTEEM registrative trials (ESTEEM 1-2).