Poster abstracts
events (AEs) in Period A were reported by 55.6% PBO vs 56.9%
ADA (with PsA: 56.3% PBO vs 56.7% ADA; without PsA: 55.3%
PBO vs 57.0% ADA without PsA); serious AEs by 4.6% PBO vs
7.3% ADA (with PsA: 9.4% PBO vs 10.0% ADA; without PsA:
2.6% PBO vs 6.3% ADA).
Conclusions: The results demonstrated that in this population,
ADA was more effective than PBO for the treatment of fingernail
Ps, and significantly improved signs and symptoms, both overall
and regardless of the presence or abscense of PsA; no new safety
risks were identified with ADA eow treatment for 26 weeks.
Previously published J Am Acad Derm. 2017. 76(6 suppl 1): AB204.
P059
CERTOLIZUMAB PEGOL IS EFFECTIVE FOR
CHRONIC PLAQUE PSORIASIS ACROSS PATIENT
SUBGROUPS
Kristian Reich 1 , Andrew Blauvelt 2 , Diamant Thaçi 3 , Craig Leo-
nardi 4 , Yves Poulin 5 , Daniel Burge 6 , Luke Peterson 7 , Catherine
Arendt 8 , Alice B Gottlieb 9
SCIderm Research Institute, Hamburg, and Dermatologikum Berlin, Ger-
many, 2 Oregon Medical Research Center, Portland, OR, USA, 3 University
Hospital of Schleswig-Holstein Campus Lübeck, Lübeck, Germany, 4 Cen-
tral Dermatology and Saint Louis University School of Medicine, St. Louis,
MO, USA, 5 Centre de Recherche Dermatologique du Québec Métropolitain,
Québec, Canada, 6 Demira, Inc., Menlo Park, CA, 7 UCB Pharma, Raleigh,
NC, USA, 8 UCB Pharma, Brussels, Belgium, 9 Department of Dermatology,
New York Medical College at Metropolitan Hospital, New York, NY, USA
1
Introduction: The Fc-free, PEGylated, anti-tumor necrosis factor
certolizumab pegol (CZP) has shown efficacy in chronic plaque
psoriasis (PSO). [1,2]
Objectives: To assess the efficacy of CZP to 48 weeks across
patient (pt) demographic and baseline disease characteristic sub-
groups in phase 3 trials.
Methods: In this prespecified, pooled subgroup analysis, data
were pooled from CIMPASI-1 (NCT02326298) and CIMPASI-2
(NCT02326272), ongoing phase 3 trials in adults with moderate
to severe PSO ≥6 months (psoriasis area and severity index [PASI]
≥12, affected body surface area [BSA] ≥10%, physician’s global
assessment [PGA] ≥3/5). Pts were randomized 2:2:1 to CZP 400
mg every 2 weeks (Q2W), 200 mg Q2W (400 mg loading dose at
Weeks 0/2/4), or placebo (PBO). At Week 16, PASI 50 responders
receiving CZP continued the same dose through the maintenance
period to Week 48. PASI 50 nonresponders at Weeks 32/40/48 were
classed as nonresponders at subsequent time points. Subgroups
included age, weight, body mass index (BMI), baseline PASI, BSA
and PSO duration. PASI 75, PGA 0/1, and PASI 90 responder rates
were summarized at Week 16 using a logistic regression model
with multiple imputation (overall population) and descriptively at
Week 48 based on nonresponse imputation (subgroups).
Results: 175/186/100 pts received CZP 400 mg Q2W/CZP 200
mg Q2W/PBO. Efficacy was observed across all subgroups for
both CZP 400 mg Q2W and 200 mg Q2W, with higher Week 48
PASI 75 responder rates in CZP 400 mg Q2W vs CZP 200 mg
Q2W treated pts (Table). Similar trends were observed for PGA
0/1 and PASI 90.
Conclusions: Treatment with either dose of CZP resulted in
clinically meaningful improvements in signs and symptoms of
PSO at Week 16 maintained at Week 48. Similar to the overall
population, PASI 75, PGA 0/1, and PASI 90 responder rates were
greater for CZP 400 mg Q2W versus 200 mg Q2W across most
subgroups at Week 48.
References:
1. Reich K (2017). Skin,1;s23; 2. Augustin M (2017). Skin,1;s24
27
Table: Week 48 PASI 75 subgroup responder rates
Baseline demographics
Weight (kg)
≤ 74.00
> 74.00– ≤ 85.00
> 85.00– ≤ 95.40
> 95.40– ≤ 109.00
> 109.00
BMI (kg/m 2 )
≤ 25.44
> 25.44– ≤ 28.68
> 28.68– ≤ 31.92
> 31.92– ≤ 37.16
> 37.16
Age (years)
< 40
≥40– < 64
≥65
Baseline disease characteristics
PSO duration (years, median)
≤ 15.00
> 15.00
PASI (median)
≤ 17.00
> 17.00
BSA (%, median)
≤ 19.0
> 19.0
CZP 400 mg Q2W
CZP 200 mg Q2W
(n = 175
(n = 186)
PASI 75 responders
PASI 75 responders
N n (%)
N
n (%)
40
36
36
28
35 32 (80.0)
28 (77.8)
26 (72.2)
18 (64.3)
24 (68.6) 32
35
34
45
40 23 (71.9)
24 (68.6)
23 (67.6)
26 (57.8)
21 (52.5)
37
39
39
25
35 30 (81.1)
36 (92.3)
26 (66.7)
16 (64.0)
20 (57.1) 35
33
32
48
38 25 (71.4)
25 (75.8)
20 (62.5)
30 (62.5)
17 (44.7)
65
97
13 54 (83.1)
66 (68.0)
8 (61.5) 67
107
12 45 (67.2)
65 (60.7)
7 (58.3)
84
91 61 (72.6)
67 (73.6) 96
90 64 (66.7)
53 (58.9)
79
96 55 (69.6)
73 (76.0) 97
89 59 (60.8)
58 (65.2)
88
87 67 (76.1)
61 (70.1) 97
89 60 (61.9)
57 (64.0)
P060
DISCONTINUATION OF BIOLOGIC THERAPIES IN
CHRONIC PLAQUE PSORIASIS: A RETROSPECTIVE
COHORT
Susanne Gulliver, Wayne Gulliver, Shane Randell
NewLab Clinical Research
Introduction: Psoriasis is a chronic debilitating auto immune
disease which manifests on the skin through red scaly plaques.
Biologic treatment have been very successful in controlling mode-
rate to severe psoriasis, however they are quite expensive and not
all treatments work for all patients. This study looks to understand
the demographics, treatment patterns, treatment failures, number
of therapies and time to switching. A cohort of 459 patients treated
with biologics was examined
Objectives: 1. To understand the demographics, treatment patterns,
treatment failures, number of therapies and time to switching.
2. To decipher patterns in biologic use in order to prescribe more
efficiently and optimize health care resources.
Methods: This was a retrospective cohort of all patients exposed
to biologic or PD-4 inhibitors within a single Dermatologist’s
private practice. A simple summary of patient demographics
including gender, treatment patterns, reasons and length of time
before discontinuation was compiled. Reasons for discontinuation
included lack of efficacy (primary or secondary), adverse events
(AEs), patient choice or other.
Results: There were 189 females (41.2%) and 270 males (58.8%)
with 914 incidences of biologic or PD-4 inhibitor treatment. The
mean age was 53.48 ± 12.6 and the mean treatment duration was
37.3 months ± 39.5 (approx. 3000 treatment years).
39.2% of patients (180) remained on the first biologic (range 0.5
to 15 years). The mean number of therapies was 1.99 (range 1–8),
but increased to 2.63 if patients were not biologic naive.
More male patients stayed on their first biologic (74.2% in
ustekinumab-treated patients and in the Apremilast group 32.3%).
Reasons for discontinuation: AEs (14.69%) and non-response
(30%); highest rates were in etanercept (78.0%), and infliximab
(75.4%); lowest rates was in etanercept 12.8% (14 of 109 patients),
highest in infliximab 34.9%, (44 of 126 patients.
Conclusions: The most common cause for discontinuation of
biologics was an AE and non-responsiveness (45.69%). Women
Acta Derm Venereol 2018