Poster abstracts
n = 229) or 2 weeks (Q2W, n = 226) after a 160mg starting dose or
placebo (PBO, n = 224). At baseline and Week 24, joint and skin
diseases were measured by the Disease Activity index for PSo-
riatic Arthritis (DAPSA; calculated post-hoc) and Psoriasis Area
and Severity Index (PASI), respectively. HRQoL was measured
by EuroQoL 5 Dimensions Visual Analog Scale (EQ-5D VAS),
Short Form-36 Health Survey (SF-36), and Work Productivity
and Activity Impairment-Specific Health Problem (WPAI). The
synergistic contribution of skin and joint improvements to HRQoL
was modeled using smoothing spline method and depicted with
response surface. Missing data were imputed using last observa-
tion carried forward.
Results: Of 679 PBO- and IXE-treated patients in the SPIRIT
trials, 402 (65%) and 224 (36%) patients had ≥3% body surface
area (BSA) and ≥10% BSA psoriasis at baseline, respectively. In
thes e patients, we applied response surface modeling to investigate
the relationship among DAPSA, PASI, and change from baseline
in EQ-5D VAS at Week 24. The greatest improvement in EQ-5D
VAS was associated with the largest percent improvements in
both DAPSA and PASI together, rather than DAPSA or PASI
alone. Similar observations, regardless of ≥3% or ≥10% BSA ba-
seline psoriasis, were made in domains of SF-36 (General Health,
Physical Functioning, Social Functioning, and Vitality; data not
shown) and WPAI (Activity Impairment; data not shown).
Conclusion: For PsA patients with psoriasis, optimal improve-
ments in patients’ HRQoL, as measured by select domains of
patient-reported outcomes, were dependent on successful treatment
of both joint and skin symptoms.
Kavanaugh A, Gottlieb A, Morita A, Merola J, Birt J, Lin C-Y, Shuler
CL, Thaci D. The Contribution of Skin and Joint Improvements to the
Health-Related Quality of Life of Patients with Active Psoriatic Arthritis.
Arthritis Rheumatol. 2017;69(Suppl 10).
P115
47
continuation improvement of palmoplantar disease for all effi-
cacy parameters. The effect was sustained through 2.5 years with
59.2% and 52.5% of subjects in secukinumab 300 and 150 mg
groups, respectively [multiple imputation (MI)] achieving clear
or almost clear palms and soles (ppIGA 0/1). Consistent with this
observation, the mean palmoplantar Psoriasis Area and Severity
Index % change from baseline reached –74.7% and –61.6% for
secukinumab 300 and 150 mg, respectively, at 2.5 years (MI).
The Dermatology Life Quality Index 0/1 response, was achieved
in 45.5% vs. 23.9% of subjects for secukinumab 300 and 150
mg groups respectively (LOCF). Pain and function of palms and
soles was markedly improved with secukinumab; as reflected by
the Palmoplantar Quality of Life Instrument overall scores with
16.7% and 17.9% subjects experiencing no difficulty in hand and
feet functionality in secukinumab 300 mg and 150 mg groups
respectively (LOCF). The safety profile was consistent with that
seen in secukinumab phase 3 trials. The most common adverse
events across all treatment arms were nasopharyngitis, upper
respiratory tract infection and headache.
Conclusions: GESTURE, the largest and longest duration rando-
mised controlled trial to date, revealed that secukinumab provides
a novel treatment option for the challenging and infrequently
studied ppPsO population by providing a strong and sustained
response through 2.5 years.
References:
1. Kumar B, et al. Acta Dermatol Venereol. 2002; 82:192–5.
2. Gottlieb A, et al. J Am Acad Dermatol. 2017; 76:70–80.
This investigation was sponsored by Novartis Pharma AG, Basel, Swit-
zerland .
P116
SECUKINUMAB SHOWS HIGH AND SUSTAINED
EFFICACY IN NAIL PSORIASIS: 2.5-YEAR
TRANSFIGURE STUDY RESULTS
SECUKINUMAB SHOWS HIGH AND SUSTAINED
EFFICACY IN SUBJECTS WITH MODERATE TO
SEVERE PALMOPLANTAR PSORIASIS: 2.5-YEAR
RESULTS FROM THE GESTURE STUDY
Alice B Gottlieb 1 , John Sullivan 2 , Alexey Kubanov 3 , Ruquan You 4 ,
Pascaline Regnault 5 , Jennifer Frueh 5 Kristian Reich 1 , Petr Arenberger 2 , Ulrich Mrowietz 3 , Sasha Jazayeri 4 , Mat-
thias Augustin 5 , Anne Parneix-Spake 6 , Pascaline Regnault 7 , Ruquan You 8 ,
Jennifer Frueh 7
1
Dermatologikum Berlin and SCIderm Research Institute, Hamburg, Ger-
many, 2 Department of Dermatology, Charles University, 3rd Faculty of
Medicine, Prague, Czech Republic, 3 Psoriasis Center at the Department
of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Ger-
many, 4 Alliance Dermatology and MOHS Center, Phoenix, USA, 5 Univer-
sität Hamburg, Hamburg, Germany, 6 Novartis Pharmaceuticals Corpora-
tion, East Hanover, USA, 7 Novartis Pharma AG, Basel, Switzerland, 8 China
Novartis Institutes for BioMedical Research, Shanghai, China
Introduction: Palmoplantar psoriasis (ppPsO) occurs in up to 40%
of plaque psoriasis subjects and is often resistant to treatment. It
is associated with pain, functional limitations, and greater impair-
ment of health related quality of life compared with plaque pso-
riasis on other parts of the body (1). Secukinumab, a fully human
monoclonal antibody which selectively neutralises IL-17A, has
shown long lasting efficacy and safety in the complete spectrum
of psoriasis manifestations, including nails, scalp, palms and soles
and psoriatic arthritis.
Objectives: Here we report, the long-term follow-up efficacy and
safety results from the GESTURE study, the first robust (2.5-year)
data reported in subjects with moderate to severe ppPsO treated
with secukinumab.
Methods: GESTURE is a double blind, randomised, placebo-con-
trolled, parallel-group, multicentre phase 3b study to investigate
safety and efficacy of secukinumab 150 and 300 mg s.c. in 205
subjects with moderate to severe ppPsO.
Results: As previously reported, after 16 weeks placebo-controlled
treatment, the primary endpoint palmoplantar Investigator’s Global
Assessment (ppIGA) 0/1 and all secondary endpoints of this study
were met, demonstrating superiority of secukinumab to placebo
at week 16 (2). An interim analysis at week 80 established the Introduction: Nail psoriasis is associated with decreased finger
mobility, functional impairment, pain and reduced quality of life
(QoL) and is often challenging to treat. It correlates with more
severe psoriatic disease and is an important predictor of psoriatic
arthritis (PsA). Nails are affected in up to 50% of psoriasis patients,
with a lifetime incidence as high as 90% 1 . Secukinumab, a fully
human monoclonal antibody that selectively neutralises IL-17A,
has shown long lasting efficacy and safety in the complete spec-
trum of psoriasis manifestations, including nails, scalp, palms and
soles and psoriatic arthritis.
Objectives: Here, we report the long-term follow-up efficacy and
safety results from the TRANSFIGURE study, the first robust
(2.5-year) data reported in subjects with nail psoriasis treated
with secukinumab.
Methods: TRANSFIGURE is a double blind, randomised,
placebo-controlled, parallel group, multi-centre phase 3b study,
to investigate safety and efficacy of secukinumab 150 and 300 mg
s.c. in moderate to severe nail psoriasis, involving 198 subjects.
Results: As previously reported, at week 16 the primary end-
point NAPSI (NAil Psoriasis Severity Index) and all secondary
endpoints of this study was met, demonstrating superiority of
secukinumab to placebo after 16 weeks placebo-controlled treat-
Department of Dermatology, New York Medical College, Metropolitan
Hospital, NY, USA, 2 Holdsworth House Medical Practice, Darlinghurst,
Australia, 3 State Scientific Center of Dermatology, Venereology and Cos-
metology, Moscow, Russia, 4 China Novartis Institutes for BioMedical Re-
search, Shanghai, China, 5 Novartis Pharma AG, Basel, Switzerland
1
Acta Derm Venereol 2018