Secukinumab efficacy and safety in indian patients with moderate-to-severe plaque psoriasis: Sub-analysis from FIXTURE, a randomized, placebo-controlled, phase 3 study

Abstract

Title:Secukinumab efficacy and safety in Indian patients with moderate-to-severe plaque psoriasis: sub-analysis from FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), a randomized, placebo-controlled, phase 3 study.Background:Evidence has suggested Interleukin (IL)-17A to be an important effector cytokine in the pathogenesis of psoriasis. Here, we report results for an Indian sub-population from a multinational study FIXTURE, designed to assess the safety, tolerability, and long-term efficacy of fully human anti–IL-17A monoclonal antibody secukinumab in patients with moderate-to-severe plaque psoriasis.Materials and Methods:In this double-dummy, placebo controlled, 52-weeks phase 3 study FIXTURE, 149 Indian patients were randomized 1:1:1:1 to receive secukinumab at a dose of 300 mg or 150 mg, etanercept, or placebo. The study objective was to show the superiority of secukinumab over placebo at week 12, vis-à-vis proportion of patients achieving a reduction of 75% or more from the baseline in the psoriasis area-and-severity index score (PASI 75) and a score of 0 (clear) or 1 (almost clear) on a 5-point modified investigator's global assessment (IGA mod 2011) (co-primary end points).Results:At week 12, 61.0% and 55.9% patients in secukinumab 300 mg and 150 mg groups, respectively, achieved PASI 75 response compared to 20.0% in the etanercept and 7.1% in the placebo groups. Similarly, IGA mod 2011 0 or 1 response was achieved by 43.9% and 20.6% in patients in the secukinumab 300 mg and 150 mg group, respectively, vs. 13.3% in the etanercept and 2.4% in the placebo groups at week 12. Likewise, higher proportions of patients in secukinumab 300 mg (41.5%) and 150 mg (20.6%) group were PASI 90 responders at week 12 than those in the etanercept (10.0%) or placebo (0.0%) groups. The incidences of adverse events (AEs), during the induction period were similar in all the treatment groups. Overall secukinumab was well-tolerated at both doses in the Indian sub-population.Conclusion:The results from the Indian sub-population suggest that secukinumab is an efficacious and safe drug for use in moderate-to-severe chronic plaque psoriasis

IL-17A in Psoriasis and Beyond: Cardiovascular and Metabolic Implications

“…With respect to available in vitro data and to data from experimental animal studies, neutralization of IL-17 should rather improve a coexistent type 2 diabetes than worsen it (127,146). In addition, biologicals targeting the IL-17 or IL-12/23 pathway seem to be weight-neutral and do not worsen preexistent type 2 diabetes or increase the risk of diabetes manifestation (148)(149)(150)(151)(152)(153)(154)(155).…”

Secukinumab efficacy in the treatment of various types of psoriasis: A case series

“…Among them, FIXTURE study showed that in moderate to severe psoriasis secukinumab provided faster onset of action and sustained higher clinical efficacy, compared to etanercept. [4] In GESTURE study, the largest randomized controlled trial in palmoplantar psoriasis, and secukinumab demonstrated the greatest efficacy to date for treating difficult-to-treat psoriasis. [5] Figure 1: Psoriatic erythroderma before and after treatment.…”

<p>Spotlight on itolizumab in the treatment of psoriasis – current perspectives from India</p>

“…In various randomized control trials conducted on Indian patients, PASI 75 response at week 12 was 58.5% in those who received 300 mg/kg of secukinumab,22 50% in those who received 150 mg/kg of secukinumab,22 36.4% in those who received 1.6 mg/kg two weekly who received 1.6mg/kg of Itolizumab once in 2 weeks,11 27% in those who received 0.4 mg/kg/week for 4 weeks and then 1.6 mg/kg every 2 weeks of itolizumab,11 and 19.4% in those who received etanercept 22…”