title: 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: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Dermatology, Father Muller Medical College, Mangalore, India.
authors.forename: Ramesh M
authors.initials: RM
authors.lastname: Bhat
authors.affiliation: Diabetes and Shridi Skin Care Centre, Bengaluru, India.
authors.forename: B
authors.initials: B
authors.lastname: Leelavathy
authors.affiliation: Department of Dermatology, Victoria Hospital, Bengaluru, India.
authors.forename: Sacchidanand S
authors.initials: SS
authors.lastname: Aradhya
authors.affiliation: Department of Skin, Kempegowda Institute of Medical Sciences, Bengaluru, India.
authors.forename: Maragondanahalli G
authors.initials: MG
authors.lastname: Gopal
authors.affiliation: Durgabai Deshmukh Hospital and Research Centre, Hyderabad, India.
authors.forename: D V S
authors.initials: DV
authors.lastname: Pratap
authors.affiliation: Cuticare Centre, Hyderabad, India.
authors.forename: Mir
authors.initials: M
authors.lastname: Mubashir
authors.affiliation: Department of Dermatology, Osmania General Hospital, Hyderabad, India.
authors.forename: Putta
authors.initials: P
authors.lastname: Srinivas
authors.affiliation: Department of Dermatology, Sparsh Hospital and Polyclinic, Nagpur, Maharashtra, India.
authors.forename: Sushil Y
authors.initials: SY
authors.lastname: Pande
authors.affiliation: Department of Dermatology, Novartis India Limited, Mumbai, Maharashtra, India.
authors.forename: Amit S
authors.initials: AS
authors.lastname: Thavkar
keywords: Interleukin (IL)-17A; PASI 75; plaque psoriasis; secukinumab