BioSpace has reported on data from a Phase IV study evaluating etanercept in the treatment of psoriasis with scalp involvement, to be presented at the 69th Annual American Academy of Dermatology (AAD) meeting.

The double-blind study included 124 adults with moderate to severe plaque psoriasis with scalp involvement.  All had a Psoriasis Area Severity Index (PASI) score of ≥10, an affected body surface area ≥10%, a Psoriasis Scalp Severity Index (PSSI) score of ≥15, and an affected scalp surface area of ≥30%.  They were randomised to treatment with 12 weeks of etanercept 50mg twice weekly followed by 12 weeks of 50mg once weekly (group A), or 12 weeks of placebo twice weekly followed by 12 weeks of etanercept 50mg twice weekly (Group B). 

The primary endpoint was the mean percent improvement from baseline in PSSI at week 12 – this was 87% in Group A and 20% in group B (P<0.0001).  The response to the etanercept treatment seen in Group A at 12 weeks was maintained at 24 weeks despite use of the lower dose for the second study period (PSSI response of 91%).  Those in Group B had a mean improvement in PSSI of 79% at week 24 (after 12 weeks of etanercept), which was similar to that seen after 12 weeks in Group A.

Patient satisfaction with treatment, as determined by a 5-point scale (very dissatisfied to very satisfied), was a patient-reported secondary endpoint of the study.   At week 12, 75% of patients treated with etanercept were either satisfied or very satisfied with their treatment, compared with 21% of patients on placebo (P<0.0001).

In an exploratory analysis, the mean percent improvement from baseline in PASI was 74% in Group A compared with 11% in Group B at week 12 (P<0.0001). At week 24, the mean percent improvement from baseline was 78% in Group A and 68% in Group B.