Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate‐to‐severe psoriasis through 5 years of treatment (SCULPTURE Extension Study)

Abstract

BackgroundSecukinumab, a fully human monoclonal antibody that selectively neutralizes IL‐17A, has been shown to have significant efficacy and a favourable safety profile in the treatment of moderate‐to‐severe psoriasis and psoriatic arthritis.ObjectiveTo assess the efficacy and safety of secukinumab through 5 years of treatment in moderate‐to‐severe psoriasis.MethodsIn the core SCULPTURE study, Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 continued receiving subcutaneous secukinumab until Year 1. Thereafter, patients entered the extension phase and continued treatment as per the core trial. Treatment was double‐blinded until the end of Year 3 and open‐label from Year 4. Here, we focus on the 300 mg fixed‐interval (every 4 weeks) treatment, the recommended per label dose. Efficacy data are primarily reported as observed, but multiple imputation (MI) and last observation carried forward (LOCF) techniques were also undertaken as supportive analyses.ResultsAt Year 1, 168 patients entered the extension study and at the end of Year 5, 126 patients completed 300 mg (every 4 weeks) treatment. PASI 75/90/100 responses at Year 1 (88.9%, 68.5% and 43.8%, respectively) were sustained to Year 5 (88.5%, 66.4% and 41%). PASI responses were consistent regardless of the analysis undertaken (as observed, MI, or LOCF). The average improvement in mean PASI was approximately 90% through 5 years compared with core study baseline. DLQI (dermatology life quality index) 0/1 response also sustained through 5 years (72.7% at Year 1 and 65.5% at Year 5). The safety profile of secukinumab remained favourable, with no cumulative or unexpected safety concerns identified.ConclusionSecukinumab 300 mg treatment delivered high and sustained levels of skin clearance and improved quality of life through 5 years in patients with moderate‐to‐severe psoriasis. Favourable safety established in the secukinumab phase 2/3 programme was maintained through 5 years.

Drug survival of biological therapy is showing class effect: updated results from Slovenian National Registry of psoriasis

“…Apremilast as the most unspecific inhibitor demonstrated the lowest drug survival, where approximately 80% of patients discontinued the therapy within a year. In multicenter analysis by van den Reek et al ., authors concluded that secukinumab showed 76% overall drug survival after 12 months, which is comparable to registrational clinical trial of secukinumab SCULPTURE, where 30% of patients were excluded from treatment in the first year because of lack of efficacy . So the low drug survival and the lower long‐term efficacy compared with data from phase 3 clinical trials are expected, despite a great short‐term efficacy of IL‐17 class…”

Effects of secukinumab on metabolic and liver parameters in plaque psoriasis patients

“…The total pooled population of all three studies includes 3010 patients (see for baseline characteristics). The design and populations of FIXTURE, ERASURE and SCULPTURE were previously reported in detail . Briefly, in FIXTURE, patients received secukinumab 300 mg at Weeks 0, 1, 2, 3 and 4 and then once every 4 weeks until Week 52, etanercept 50 mg twice weekly for 12 weeks and then once weekly until Week 52 or placebo to Week 16.…”

Long‐term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3‐year results of a double‐blind extension study

“…3 An extension study of the SCULPTURE core study (NCT01640951) was conducted to collect long-term double-blind data of secukinumab. 9 However, there is no report on the impact of maintenance treatment regimens, FI versus RAN, on HRQoL, and for long-term data of secukinumab in the Japanese population. 8 The study was open-label from year 4.…”