Treatment with secukinumab 300 mg in patients with moderate to severe psoriasis is associated with strong, long-lasting efficacy and improvements in health-related quality of life through 5 years, according to the results of the SCULPTURE extension study, published in the Journal of the European Academy of Dermatology and Venereology.
In the core SCULPTURE study, patients with Psoriasis Area and Severity Index (PASI) 75 response (≥75% improvement from baseline PASI score) at week 12 continued to be treated with subcutaneously administered secukinumab for 1 year.
Following this, they entered the extension phase, with treatment continued in the same manner as the core trial. Treatment was double blind until the end of year 3, then was open label from year 4. In the extension phase of SCULPTURE, participants received 300-mg fixed-interval secukinumab every 4 weeks.
At year 1, a total of 168 patients entered the extension phase. Baseline characteristics of patients in this portion of the study included a mean PASI of 23.5, body surface area involvement of 33.1%, mean Dermatology Quality of Life Index response rate of 13.1, and mean time since initial psoriasis diagnosis of 19.1 years, all of which were indicative of high disease activity at baseline.
At the end of year 5, a total of 126 participants completed treatment with secukinumab 300 mg every 4 weeks. At year 1, PASI 75/90/100 responses were 88.9%, 68.5%, and 43.8%, respectively, which were sustained through year 5 at 88.5%, 66.4%, and 41%, respectively.
The average improvement in mean PASI was approximately 90% through 5 years compared with core study baseline values. Dermatology Quality of Life Index response rate was also sustained through year 5 (year 1: 72.7%; year 5: 65.5%). In the extension phase, the safety profile of secukinumab remained favorable, and no unexpected or cumulative safety concerns emerged.
The investigators concluded that treatment with secukinumab 300 mg delivered high sustained levels of skin clearance and improved health-related quality of life in patients with moderate to severe psoriasis through 5 years of therapy. These study findings are particularly relevant for patients who may require long-term disease management.
Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile in patients with moderate to severe psoriasis through 5 years of treatment (SCULPTURE extension study) [published online February 14, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.14878