Amgen and Pfizer Inc. today announced results from a new trial that demonstrated Enbrel® (etanercept) significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo. The data will be presented today at the 69th Annual American Academy of Dermatology (AAD) meeting in New Orleans, La.
“At least half of people with plaque psoriasis have involvement on their scalp, which may contribute to feelings of embarrassment associated with this condition,” said lead author Jerry Bagel, M.D., medical director, Psoriasis Treatment Center of Central New Jersey. “These data reinforce the efficacy and safety profile of ENBREL for adult patients with moderate to severe plaque psoriasis with scalp involvement.”
In this trial, patients were randomized to either 12 weeks of ENBREL 50 mg twice weekly followed by 12 weeks of ENBREL 50 mg once weekly (Group A), or 12 weeks of placebo twice weekly followed by 12 weeks of ENBREL 50 mg twice weekly (Group B). This trial met its primary endpoint of mean percent improvement from baseline in Psoriasis Scalp Severity Index (PSSI) with 87 percent PSSI improvement in Group A compared with 20 percent in Group B at week 12 (P<0.0001). The PSSI response to ENBREL for patients in Group A was maintained through 24 weeks despite patients switching to a lower dose (91 percent). Patients in Group B saw a mean percent improvement in their PSSI score of 79 percent at week 24, similar to that achieved by the Group A patients at week 12.
In addition to the improvement in scalp involvement, in an exploratory analysis, the mean percent improvement from baseline in Psoriasis Area Severity Index (PASI) was 74 percent in Group A compared with 11 percent in Group B at week 12 (P<0.0001). At week 24, the mean percent improvement from baseline was 78 percent in Group A and 68 percent in Group B.
At week 12 in this study, 75 percent of patients treated with ENBREL.
Among the 121 patients evaluable for safety, 67.8 percent reported at least one adverse event (AE) through week 24; the most common were upper respiratory tract infections (11.6 percent), nasopharyngitis (8.3 percent), injection site reaction (5.8 percent), arthralgia (5.0 percent), and headache (5.0 percent). Three patients reported five serious AEs: cholecystitis/cholelithiasis, fall/rib fracture and metastatic malignant melanoma.