Abstract

The aim of this 12-month, observational, prospective, multicenter study was to assess the benefits of apremilast for the treatment of moderate-severe plaque psoriasis in routine practice in Spain. Interim analysis including 75 patients (mean age 52.7 years [SD15.6]) who started apremilast treatment 3 months before inclusion. 75 were followed for 3 months, and 41 for 6; 9 (12%) discontinued during the 6-month period, 6 of them due to adverse events (AEs). All patients had previously received at least one conventional systemic treatment and had not received biologicals. Mean (SD) Psoriasis Area Severity Index (PASI) was 8.3 (5.6), 3.5 (3.1), and 3.2 (4.6) at baseline, 3, and 6 months, respectively (*P * 1 and 54.2% (39/72) PBI ≥3. Pruritus intensity (VAS (SD)) decreased from 52.0 (32.6) at baseline to 28.0 (29.6, *P < .0001) and 35.4 (33.3, *P = .0048) and Dermatology Life Quality Index (DLQI [SD]) decreased from 10.6 (6.6) to 4.5 (6.2, *P < .0001) and 3.7 (5.4, *P < .0001). 45.2% (33/73) and 47.4% (18/38) of patients achieved DLQI 0/1 at months 3 and 6 respectively (***P < .0001). 25 patients (33.3%) reported AEs (1/31 [3%] was serious). The most frequent AEs were gastrointestinal alterations (14.7%). These preliminary data suggest apremilast is an effective treatment with an acceptable safety profile, providing substantial benefits for patients with moderate to severe psoriasis. *Paired t test; **McNemar test; ***Symmetry test.

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