Poster abstracts
Methods: Mean A1c change and mean percent weight change at
Wk16 were compared among pts with baseline (BL) A1c < 5.7%,
5.7% to 6.4% (prediabetes), and ≥6.5% (diabetes) and between pts
reporting/not reporting concomitant insulin use. Spearman rank cor-
relations between percent change from BL in weight and change in
A1c at Wk16 were calculated; p < 0.05 was considered significant.
Results: In the pooled EST-PAL population, 2,242 pts (PBO
n = 913; APR n = 1,329) received study medication at BL. In all,
230 pts had BL A1c ≥6.5%. At Wk16, A1c change in pts with
BL A1c < 5.7% was 0.02 with PBO and 0.04 with APR. In pts
with BL A1c 5.7% to 6.4%, small changes were observed (PBO
−0.07; APR −0.12). Greatest A1c changes were in pts with BL
A1c ≥6.5% (PBO −0.08; APR −0.31). At Wk16, mean weight
change was 0.11% (PBO) and −1.32% (APR). In pts reporting
and not reporting concomitant insulin use, mean weight change
was 0.05% and 0.12% with PBO, respectively, and −1.83% and
−1.31% with APR. Weight change in pts with BL A1c < 5.7%,
5.7% to 6.4%, and ≥6.5% was 0.02%, 0.26%, and 0.11% with
PBO, respectively, and −1.24%, −1.35%, and −1.68% with APR.
Correlations between changes in weight and A1c were generally
low, with greater correlation in APR pts with higher BL A1c. Corre-
lation was statistically significant in APR pts with BL A1c ≥6.5%.
Conclusion: With APR, decreases in weight and A1c were greater
in pts with higher BL A1c. Pts receiving APR and insulin had
weight loss despite the association between insulin use and weight
gain. Future studies may be warranted to determine whether re-
ductions in A1c with APR are independent of weight loss.
Prior presentation: AAD 2018
P029
CANADIAN HUMIRA POST-MARKETING
OBSERVATIONAL EPIDEMIOLOGICAL STUDY
ASSESSING THE EFFECTIVENESS OF ADALIMUMAB
VS NON-BIOLOGIC DMARDS IN PSORIATIC
ARTHRITIS (COMPLETE-PSA): 12-MONTH
EFFECTIVENESS DATA
Majed Khraishi 1 , Louis Bessette 2 , Andrew Chow 3 , Boulos Ha-
raouil 4 , Viktoria Pavlova 5 , Jacqueline Stewart 6 , Valencia Remple 7
1
Memorial University of Newfoundland, St. John’s NL, 2 Laval University,
Centre Hospitalier de l’Université Laval, Quebec QC, 3 University of To-
ronto ON, 4 Centre hospitalier de l’Université de Montréal, Montreal QC,
5
McMaster University, Hamilton ON, 6 University of British Columbia, Pen-
ticton BC, 7 AbbVie Corporation, Montreal QC, Canada
Background: Observational studies comparing the effectiveness
of adalimumab (ADA) to non-biologic DMARDs (nbDMARD) in
PsA patients failing prior treatment are scarce. COMPLETE-PSA
is a Canadian observational study which assessed effectiveness
of ADA and non-biological therapies (NSAIDs and DMARDs)
among PsA patients failing previous therapy.
Objectives: To describe the baseline (BL) demographic and disease
parameters and to compare 12-month real-life effectiveness of
patients initiating nbDMARD or ADA.
Methods: Eligible patients eligible are anti-TNFα naïve adults,
with active PsA requiring a treatment regimen change, per the
treating physician’s judgment. This analysis included patients
enrolled during Jul/2011–Jun/2016. Outcome measures analyzed
were: DAS28, SF-12, DLQI, presence of extra-articular manifesta-
tions (EAMs; enthesitis & dactylitis), psoriasis BSA, achievement
of modified MDA (achievement of [i] 4/6 (MDA 1) and [ii] 5/6
following criteria (MDA 2): TJC ≤ 1, SJC ≤ 1, BSA ≤ 3%, pain
VAS ≤ 15mm, PtGA ≤ 20 and HAQ ≤ 0.5), modified remission
(SJC = 0, TJC = 0, absence of enthesitis and dactylitis, BSA ≤ 3%
and HAQ ≤ 0.5), DAPSA LDA ( ≤ 14), and DAPSA remission
(REM; ≤ 4). Analyses were conducted by initial group assignment
(intent-to-treat approach).
Results: 406 patients were included (nbDMARD n = 146, ADA
n = 260). BL demographics were comparable between treatment
15
groups. However, patients initiating ADA were more likely to be
unemployed (47.3% ADA vs 34.9% nbDMARD, p = 0.015), had
higher DAS28 (4.8 vs 4.4, p = 0.002) and total DLQI score (6.1
vs 4.3, p = 0.007), and were more likely to have BSA≥3% (44.6%
vs 35.0%, p = 0.063) and high DAPSA disease activity (50.8%
vs 32.3%, p = 0.015). A higher proportion of nbDMARD patients
had dactylitis (36.1% vs 25.3%, p = 0.023). No differences were
observed between groups in enthesitis, overall EAMs, or QoL
at BL. Following 12 months, mean adjusted DAS28 (2.6 vs 3.4,
p < 0.001) and DLQI (2.2 vs 2.9, p = 0.530) scores, but not SF-12,
were lower in the ADA group. Furthermore, even though statistical
significance was not always met, ADA patients had lower DAPSA
score (p = 0.025) (LDA/REM: 64.9% vs 58.6%; REM: 37.7% vs
17.1%), were more likely to be in modified remission (14.7% vs
9.7%, p = 0.311), and to have mMDA (mMDA 1: 15.6% vs 12.6%,
p = 0.529; mMDA 2: 17% vs 11.5%, p = 0.253) and BSA < 3%
(89.3% vs 83.9%, p = 0.207). Also, EAM prevalence decreased in
both groups but was significantly lower in the ADA group (17.4%
vs 35.8%, p < 0.001). Over time, 9.6% of ADA patients initiated
another biologic and 32.2% of patients in the nbDMARD group
initiated biologic treatment (p < 0.001).
Conclusions: PsA patients initiating ADA in Canadian routine
clinical care have significantly greater BL disease severity com-
pared with those initiating nbDMARDs. However, 12-month
ADA treatment resulted in improved disease control and EAMs.
DAPSA-REM evaluation seems more sensitive than mMDA in
differentiating both populations.
P030
SECUKINUMAB EFFICACY IN PATIENTS WITH
ACTIVE PSORIATIC ARTHRITIS: META-ANALYSIS OF
4 PHASE 3 TRIALS
Philip Mease 1 , Bruce Kirkham 2 , Peter Nash 3 , Alejandro Balsa 4 ,
Bernard Combe 5 , Jürgen Rech 6 , Ruvie Martin 7 , Gregory Ligozio 7 ,
Ken Abrams 7 , Luminita Pricop 7
Swedish Medical Centre and University of Washington, Seattle, USA,
Guy’s & St Thomas’ NHS Foundation Trust, London, UK, 3 Department of
Medicine, University of Queensland, Brisbane, Australia, 4 Hospital Uni-
versitario La Paz, Instituto de Investigación Sanitaria (IdiPAZ), Madrid,
Spain, 5 Hôpital Lapeyronie, Université Montpellier 1, Montpellier, France,
6
Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Monash Uni-
versity, Germany, 7 Novartis Pharmaceuticals Corporation, East Hanover,
USA
1
2
Introduction: Secukinumab (SEC) has exhibited rapid, significant
and sustained improvement in the signs and symptoms of psoriatic
arthritis (PsA) in 4 Phase 3 studies.1–4
Objective: To report meta-analyzed efficacy results for SEC ver-
sus placebo at Week (Wk) 16 in PsA patients (pts) by prior TNF
inhibitor (TNFi) use and with/without concomitant methotrexate
(MTX) use from 4 Phase 3 studies: FUTURE 2,3,4,5.
Methods: A total of 2148 pts with active PsA were randomised in
FUTURE 2, 3, 4 and 5 studies (397, 414, 341 and 996, respecti-
vely). Study designs were described elsewhere.1–4 Assessments
included ACR20/50 by prior TNFi use (naïve/inadequate response
or intolerance [-IR]) and with/without MTX use.
Results: Out of 2049 pts in analysis, 461, 572, 335, and 681 pts
received SEC 300mg, 150mg, 150mg without load (NL) and pla-
cebo (PBO), respectively. ACR 20/50 responses were improved
with SEC vs PBO at Wk 16 in both TNFi-naive/-IR pts and pts
with/without concomitant MTX use (Table); improvements were
also observed with SEC vs PBO for all other secondary endpoints.
Conclusions: SEC provided improvement in the signs and
symptoms of active PsA regardless of previous TNFi therapy or
concomitant MTX use. Higher response rates were observed in
TNFi-naïve pts compared to TNFi-IR pts. SEC 300mg was as-
sociated with higher responses compared to 150mg in pts with
TNFi-IR and no concomitant MTX use.
Acta Derm Venereol 2018