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Year : 2017  |  Volume : 8  |  Issue : 1  |  Page : 16-24

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

1 Department of Dermatology, Father Muller Medical College, Mangalore, India
2 Diabetes and Shridi Skin Care Centre, Bengaluru, India
3 Department of Dermatology, Victoria Hospital, Bengaluru, India
4 Department of Skin, Kempegowda Institute of Medical Sciences, Bengaluru, India
5 Durgabai Deshmukh Hospital and Research Centre, Hyderabad, India
6 Cuticare Centre, Hyderabad, India
7 Department of Dermatology, Osmania General Hospital, Hyderabad, India
8 Department of Dermatology, Sparsh Hospital and Polyclinic, Nagpur, Maharashtra, India
9 Department of Dermatology, Novartis India Limited, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Ramesh M Bhat
Father Muller Medical College, Mangalore - 575 002, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-5178.198765

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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

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