L. Spelman , R. Langley , K. Reich , C. Griffiths , L. Puig , E. Rivas Zaldivar , N. Wasel , T. Salko , M. Notter
Background: The goal of FIXTURE was to investigate the
efficacy and safety of secukinumab, an anti-IL-17A mAb,
compared to placebo and etanercept in subjects with
moderate-to-severe plaque psoriasis.
Methods: This study randomized 1306 pts in to 4 arms:
secukinumab 150 mg or 300 mg, placebo or etanercept
50 mg. The co-primary objectives were the superiority of
secukinumab vs. placebo in both PASI75 and IGA-0/1 mod
2011 response at Week-12. Key secondary endpoints
included demonstration of superiority of secukinumab vs.
etanercept with respect to PASI75 and IGA-0/1 mod 2011 at
Week-12 and maintenance of response at Week-52.
Results: PASI75 and PASI90 response at Week 12 was seen
in 77.1% and 54.2% of subjects receiving 300mg, 67.0% and
41.9% of subjects receiving 150 mg, 44.0% and 20.7% of
subjects receiving etanercept, and 4.9% and 1.5% receiving
placebo. Both doses of secukinumab achieved significantly
better PASI75 results compared to placebo (P < 0.0001) and
etanercept (P = 0.025). The percentage of subjects with an
IGA-0/1 was 62.5% and 51.1% with the 300 mg and 150 mg
doses, respectively, compared with 3% with placebo(P < 0.01 both doses) and 27.2% with etanercept (P = 0.025
both doses). Secukinumab 300 mg achieved a 50% reduction
in mean PASI response after 3-weeks of treatment compared
with after 8-weeks with etanercept. The high
response rates with secukinumab were sustained through
52 weeks. The incidence rates of adverse events were comparable
across both doses of secukinumab and etanercept over the 52-weeks.
Conclusions: Secukinumab was statistically superior to
placebo and etanercept in treating moderate-to-severe plaque psoriasis in this 52-week study.
