Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials
August 2015 | Volume 14 | Issue 8 | Original Article | 821 | Copyright © August 2015
Alice B. Gottlieb MD PhD,a Richard G. Langley MD,b Sandra Philipp MD PhD,c Bardur Sigurgeirsson MD PhD,d Andrew Blauvelt MD MBA,e Ruvie Martin PhD,f Charis Papavassilis MD PhD,g and Shephard Mpofu MDg
aTufts Medical Center, Boston, MA,
bDalhousie University, Halifax, Canada
cCharité Universitätsmedizin, Berlin, Germany
dUniversity of Iceland, Reykjavik, Iceland
eOregon Medical Research Center, Portland, OR
fNovartis Pharmaceuticals, East Hanover, NJ
gNovartis Pharma AG, Basel, Switzerland
OBJECTIVE: To evaluate the efficacy of secukinumab in subjects with psoriasis and concomitant psoriatic arthritis (PsA) with respect to psoriasis symptoms and physical function, we conducted pre-specified subanalyses of the phase 3 FIXTURE and ERASURE trials.
METHODS: The 52-week FIXTURE and ERASURE trials randomized subjects with moderate-to-severe plaque psoriasis to subcutaneous secukinumab 300 or 150 mg (Baseline, weeks 1, 2, 3, every 4 weeks from week 4 until week 48), etanercept 50 mg (twice weekly through week 12, once weekly thereafter through week 51; FIXTURE only), or placebo. In this analysis, changes in Health Assessment Questionnaire–Disability Index (HAQ-DI) and PASI 75 responses were assessed in subpopulations with concomitant PsA (n=196, FIXTURE; n=171, ERASURE).
RESULTS: Physical functioning (mean change from Baseline in HAQ-DI) was greater with secukinumab 300 mg vs. placebo at week 12 in both trials (FIXTURE, -0.41 vs. 0.02/P=0.0001; ERASURE, -0.35 vs. -0.08/P=0.0003); corresponding values were -0.29 for etanercept and -0.19 for secukinumab 150 mg in FIXTURE and -0.18 for secukinumab 150 mg in ERASURE. Greater responses were seen in subjects with greater Baseline disability (HAQ-DI ≥05). Week 12 PASI 75 responses were higher with secukinumab 300 mg/150 mg vs. placebo in FIXTURE (72%/59% vs. 2%) and ERASURE (68%/70% vs. 4%; all P<0.0001) and with secukinumab 300 mg vs. etanercept (72% vs 39%; P=0.0084).
CONCLUSION: Secukinumab 300 mg produced significant improvement in psoriasis and physical functioning in subjects with concomitant PsA.
ClinicalTrials.gov numbers: NCT01358578 (FIXTURE); NCT01365455 (ERASURE)
J Drugs Dermatol. 2015;14(8):821-833.