PMID- 28217466
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2229-5178 (Print)
IS  - 2249-5673 (Electronic)
IS  - 2229-5178 (Linking)
VI  - 8
IP  - 1
DP  - 2017 Jan-Feb
TI  - Secukinumab efficacy and safety in indian patients with moderate-to-severe plaque 
      psoriasis: Sub-analysis from FIXTURE, a randomized, placebo-controlled, phase 3 
      study.
PG  - 16-24
LID - 10.4103/2229-5178.198765 [doi]
AB  - 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-a-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.
FAU - Bhat, Ramesh M
AU  - Bhat RM
AD  - Department of Dermatology, Father Muller Medical College, Mangalore, India.
FAU - Leelavathy, B
AU  - Leelavathy B
AD  - Diabetes and Shridi Skin Care Centre, Bengaluru, India.
FAU - Aradhya, Sacchidanand S
AU  - Aradhya SS
AD  - Department of Dermatology, Victoria Hospital, Bengaluru, India.
FAU - Gopal, Maragondanahalli G
AU  - Gopal MG
AD  - Department of Skin, Kempegowda Institute of Medical Sciences, Bengaluru, India.
FAU - Pratap, D V S
AU  - Pratap DV
AD  - Durgabai Deshmukh Hospital and Research Centre, Hyderabad, India.
FAU - Mubashir, Mir
AU  - Mubashir M
AD  - Cuticare Centre, Hyderabad, India.
FAU - Srinivas, Putta
AU  - Srinivas P
AD  - Department of Dermatology, Osmania General Hospital, Hyderabad, India.
FAU - Pande, Sushil Y
AU  - Pande SY
AD  - Department of Dermatology, Sparsh Hospital and Polyclinic, Nagpur, Maharashtra, 
      India.
FAU - Thavkar, Amit S
AU  - Thavkar AS
AD  - Department of Dermatology, Novartis India Limited, Mumbai, Maharashtra, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian Dermatol Online J
JT  - Indian dermatology online journal
JID - 101586880
PMC - PMC5297264
OTO - NOTNLM
OT  - Interleukin (IL)-17A
OT  - PASI 75
OT  - plaque psoriasis
OT  - secukinumab
COIS- Ramesh Bhat has received research grants from Novartis Pharmaceuticals. Amit 
      Thavkar is an employee of Novartis India Limited.
EDAT- 2017/02/22 06:00
MHDA- 2017/02/22 06:01
PMCR- 2017/01/01
CRDT- 2017/02/21 06:00
PHST- 2017/02/21 06:00 [entrez]
PHST- 2017/02/22 06:00 [pubmed]
PHST- 2017/02/22 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - IDOJ-8-16 [pii]
AID - 10.4103/2229-5178.198765 [doi]
PST - ppublish
SO  - Indian Dermatol Online J. 2017 Jan-Feb;8(1):16-24. doi: 10.4103/2229-5178.198765.