Poster abstracts
Wk72. Among the 182 patients in the withdrawal arm, 117 were
retreated with GUS prior to Wk72; 56 did not meet retreatment
criteria and initiated retreatment at Wk72 per protocol. Of 173
patients retreated, 87.6% achieved PASI90 within 6 months of
commencing retreatment. No new safety signals were observed
with GUS withdrawal and retreatment through Wk100. Mainte-
nance of PASI90 response after drug withdrawal was associated
with continued suppression of IL-17A, IL-17F, & IL-22, while
loss of response was associated with increased levels of these
circulating cytokines.
Conclusion: Superior maintenance of high efficacy response rates
was achieved with continuous GUS treatment vs withdrawal, and
the majority of retreated patients achieved PASI90. Maintenance
of PASI90 after drug withdrawal was associated with continued
suppression of IL-17A, IL-17F, and IL-22.
P050
OUTCOMES ASSOCIATED WITH ACHIEVEMENT OF
VARIOUS TREATMENT TARGETS IN PATIENTS WITH
PSORIATIC ARTHRITIS RECEIVING ADALIMUMAB
Josef S. Smolen 1 , Daniel Aletaha 1 , Dafna D. Gladman 2 , Ying
Zhang 3 , Fabiana Ganz 4
Medical University of Vienna, Vienna, Austria, University of Toronto, To-
ronto Western Hospital, Toronto, Ontario, Canada, 3 AbbVie, Inc., North
Chicago, IL, USA, 4 AbbVie, Inc., Baar, Switzerland
1
2
Background: Various instruments are currently used for disease
activity and outcome assessment in psoriatic arthritis (PsA). Some
measures attempt to incorporate the total spectrum of psoriatic
disease manifestations [eg, minimal disease activity (MDA)] while
others focus on arthritis assessments [eg, disease activity index
for PsA (DAPSA)]. Whether in patients (pts) with PsA it is suf-
ficient to primarily consider joint disease aspects remains unclear.
Objective:To compare DAPSA remission and low disease activity
(LDA) with MDA and very low disease activity (VLDA) for the
presence of residual abnormalities of the respective composing
variables.
Methods: This post hoc analysis included pts with PsA receiving
adalimumab (ADA) in one of two multicenter studies: ADEPT was
a 24-week (wk), randomized, double-blind, placebo-controlled
trial; ACCLAIM was a 12-wk, open-label study conducted in
Canada in care settings that reflected usual practice. Frequencies
of DAPSA remission/LDA and MDA/VLDA were summarized,
and the individual PsA manifestations within these states were
assessed. DAPSA was summed from the following continuous
variables: swollen (66) and tender (68) joints, pt global assess-
ment (PtGA, cm), pt pain (PP, cm), and C-reactive protein (CRP,
mg/dL). DAPSA remission was defined as ≤ 4 and DAPSA LDA
as > 4 and ≤ 14. MDA criteria were as follows: ≤ 1 tender, ≤ 1
swollen joint, ≤ 1 entheseal point, PP ≤ 15mm, PtGA ≤ 20mm,
HAQ ≤ 0.5, and PASI ≤ 3. MDA was calculated as fulfilling 5
of the 7 criteria, and VLDA calculated as fulfilling all 7 criteria.
Data were as observed.
Results: Among 151 pts receiving ADA in ADEPT, 33 (22%) each
achieved DAPSA remission and LDA at wk 24, and 20 (14%) and
11 (7%) achieved MDA and VLDA, respectively. Pts achieving
DAPSA LDA appeared to mirror those in MDA, with the exception
of experiencing numerically higher PP, PtGA, and PASI scores
at wk 24. Pts in DAPSA LDA did experience numerically lower
SJC when compared with the MDA achievers, and, like MDA
achievers, displayed little residual enthesitis. Only VLDA, but not
MDA, could match the stringency of DAPSA remission, a finding
that was confirmed through analysis of the ACCLAIM cohort.
However, VLDA allowed for numerically higher residual PP and
PtGA levels when compared with DAPSA remission. Importantly,
residual enthesitis did not differ among pts achieving DAPSA
remission or VLDA. Irrespective of disease activity assessment,
pts receiving ADA displayed little to no radiographic progression.
23
Conclusions: In the ADEPT and ACCLAIM cohorts, pts who
achieved DAPSA remission or VLDA demonstrated similar
outcomes with respect to the individual components of both sco-
res, despite the omission of several of these within the DAPSA.
Given the DAPSA’s continuous nature, its use may offer a good
alternative to fulfillment of the VLDA criteria, but these results
require confirmation in different pt populations.
Previously published Ann Rheum Dis 2017.
P051
EFFICACY AND SAFETY OF IXEKIZUMAB IN
PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS:
THREE YEAR RESULTS FROM A PHASE 3 STUDY
(SPIRIT-P1)
Vinod Chandran 1 , Roy Fleischmann 2 , Eric Lespessailles 3 , Philip
Helliwell 4 , Olivier Benichou 5 , Janelle Erickson 5 , Catherine Shuler 5
Krembil Research Institute, University of Toronto, Toronto, Canada,
Metroplex Clinical Research Center, Dallas, USA, 3 University Orléans,
Orléans, France, 4 University of Leeds, UK, 5 Eli Lilly and Company, India-
napolis, USA
1
2
Introduction: Ixekizumab (IXE), an interleukin-17A antagonist,
was superior to placebo (PBO) in improving the signs and symp-
toms of psoriatic arthritis (PsA) at Week 24 in biologic-naïve
patients (pts).
Objective:To determine the efficacy and safety of IXE treatment
up to 3 years in biologic-naïve pts with PsA. Methods: In the
SPIRIT-P1 Phase 3 trial (NCT01695239), 210 pts were randomi-
zed to IXE (80 mg every 4 [Q4W] or 2 [Q2W] weeks), 101 pts to
adalimumab (active reference arm), and 106 pts to PBO at Week
0. ADA and PBO patients were re-randomized to IXE at the end
of the double-blind treatment period. Ad-hoc efficacy for all pts
initially randomized to IXE (intent-to-treat [ITT]) is presented.
Modified non-responder imputation (missing data considered non-
response for pts discontinued due to lack of efficacy or adverse
events [AEs]; multiple imputation for all other missing data) was
applied to efficacy response outcomes. Ad hoc safety data, for all
pts who received at least one IXE dose during the trial (n = 386),
are presented as exposure-adjusted incidence rates (IRs; number
of pts with events*100 /total pt years [PY]).
Results: Efficacy results are summarized for ITT IXE-treated pts
(Table 1). Improvements in ACR (American College of Rheu-
matology) responses, enthesitis, dactylitis, PASI (Psoriasis Area
and Severity Index), and NAPSI (Nail Psoriasis Severity Index)
persisted up to 3 years. Safety assessments for all pts initially
randomized to IXE or re-randomized to IXE during SPIRIT-P1 are
summarized (Table 2). IRs of treatment-emergent AEs (TEAEs)
were similar between IXE Q4W and Q2W treatment groups.
Table 1. Efficacy Outcome Measures at Week 156 (ITT IXE-Treated Population)
IXE Q4W (n = 107)
IXE Q2W (n = 103)
ACR20
69%
62%
ACR50
51%
56%
ACR70
33%
44%
47%
40%
LEI = 0a
62%
69%
LDI-B = 0b
PASI75c
63%
69%
PASI90c
51%
65%
PASI100c
44%
61%
54%
57%
NAPSI = 0d
a
Pts with Leeds Enthesitis Index (LEI) > 0 at baseline. b Pts with Leeds Dactylitis Index-Basic
c
(LDI-B) > 0 at baseline. Pts with psoriatic lesions ³3% of body surface area at baseline. d Pts with
fingernail psoriasis at baseline.
Table 2.
Total IXE Q4W
Total IXE Q2W
(n = 195;Total PY = 450.4) (n = 191; Total PY = 442.1)
TEAEs
169 (37.5)
168 (38.0)
Serious AEs
38 (8.4)
23 (5.2)
Serious Infections
8 (1.8)
2 (0.5)
Discontinued due to AE
17 (3.8)
23 (5.2)
Death
1a (0.2)
0
Infections
111 (24.6)
112 (25.3)
Injection-Site Reactions
40 (8.9)
43 (9.7)
Hypersensitivities
10 (2.2)
21 (4.7)
n = pts with ≥1 designated AE. Data presented as n (IR). For safety analyses, baseline was defined
as the time of the first IXE injection. Total PYs is the total time pts were in the treatment period
following the first IXE injection. aPt experienced a cerebrocardiovascular accident.
Acta Derm Venereol 2018