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assessed. Missing data were recorded as non-response and Fisher’s
exact test was used to compare the proportion of responders between
groups at Wk 16. Only pooled data for pts receiving the licensed dose
of SEC (150 mg) are shown.
Results: Overall 739 patients were included, with 427 and 312 in the
SEC 150 mg and PBO groups, respectively. Of those, 37% and 36% of
the SEC and PBO groups, respectively, were classified as <2 yrs since
first AS diagnosis (Overall: 37%). The mean time since AS diagnosis
was similar for the PBO and SEC treatment groups in both the <2 yrs
(approx. 0.80 yrs) and the 2 yrs subgroups (approx.11 yrs). The least
squares mean (LSM) changes in PCS from BL to Wk 16 were increased
with SEC 150 mg compared with PBO, in both <2 yrs (PBO: 2.11; 150
mg: 6.44, p<0.0001) and 2 yrs since diagnosis (PBO: 3.03; 150 mg:
5.82, p<0.0001) groups. Significant increases were also reported in LSM
changes in MCS scores from BL to Wk 16 with SEC 150 mg in patients
<2 yrs since diagnosis (PBO: 2.10; 150 mg: 5.53, p<0.01), but not in
the 2 yrs group. Analysis of individual SF-36 domain scores showed
improvements with SEC vs PBO in the overall population and in both
time since diagnosis subgroups, except Role-Emotional and Mental Health
in the 2 yrs group (Figure). At Wk 16, the proportions of PCS respond-
ers were significantly higher with SEC 150 mg vs PBO, regardless of
time since diagnosis (<2 yrs: PBO = 50.0%, SEC = 73.6%, p<0.01; 2
yrs: PBO = 45.0%, SEC = 69.8%, p<0.0001). MCS responses were not
significantly different with SEC vs PBO in either subgroup. Overall,
improvements in SF-36 scores and clinically meaningful MCID responses
with SEC were more prominent in the <2 yrs since diagnosis compared
with the 2 yrs group. Improvements in PCS, MCS, individual SF-36
domains and overall MCID responses were sustained to Wk 52 with
SEC 150 mg.
Conclusion: Treatment with SEC 150 mg resulted in significant, clinically
meaningful, and sustained improvements in HRQoL. Although reported
irrespective of time since AS diagnosis, improvements were more promi-
nent in earlier diagnosed pts.
Acknowledgement: Study sponsored by Novartis. Medical writing support
by Seren Communications, funded by Novartis.
Disclosure of Interests: Atul Deodhar Grant/research support from: Abb-
Vie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consul-
tant for: AbbVie, Amgen, BMS, Eli Lilly, Janssen, Novartis, Pfizer, and
UCB, Annelies Boonen: None declared, Gianfranco Ferraccioli Speakers
bureau: LILLY, ROCHE, NOVARTIS, Filip van den Bosch Consultant for:
AbbVie, BMS, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and
UCB, Speakers bureau: AbbVie, BMS, Janssen, Lilly, Merck, Novartis,
Pfizer and UCB., David Martinez Consultant for: I developed the analyses
of this study paid by the pharmaceutical., Brian Porter Shareholder of:
Novartis, Employee of: Novartis, Abhijit Shete Shareholder of: Novartis
Pharma AG, Employee of: Novartis Pharma AG, Isabelle Gilloteau
Employee of: Employee of Novartis, Aurore Yocolly Employee of:
Employee of Novartis, Vibeke Strand Consultant for: Samumed, LLC,
AbbVie, Amgen, EMD Serono, Eupraxia, Flexion, Iroko, Novartis, Pfizer,
Regeneron, Sanofi, SKK
DOI: 10.1136/annrheumdis-2019-eular.2829
FRI0389 EFFECTIVENESS OF BIOLOGIC THERAPY ON DISEASE
ACTIVITY IN ANKYLOSING SPONDYLITIS: A
BIOBADASER III OBSERVATIONAL STUDY
Valentina Emperiale
1,2
, Carlos Sánchez-Piedra
2
,CristinaBohórquez
1
,
María Colazo
3
, Carlos Fernández-López
4
,NoemíBusquets
5
,InmaculadaRos
6
,J.
M. Blanco
7
, Manuel Moreno
8
,JoseCamposEsteban
9
, Carlos Rodríguez-
Escalera
10
, Fernando Sánchez-Alonso
2
, Juan Jesus Gomez-Reino
11
.
1
HU
Príncipe de Asturias, Alcalá de Henares, Spain;
2
Spanish Society of
Rheumatology, Research Unit, Madrid, Spain;
3
H de Burgos, Burgos, Spain;
4
CHU
ACoruña,ACoruña,Spain;
5
HG de Granollers, Granollers, Spain;
6
H Son Llàtzer,
Palma de Mallorca, Spain;
7
HU de Basurto, Bilbao, Spain;
8
HCU Virgen de la
Arrixaca, El Palmar, Spain;
9
HU Puerta de Hierro, Majadahonda, Spain;
10
Hde
Jaén, Jaén, Spain;
11
HCU de Santiago, Santiago de Compostela, Spain
Background: The advent of biologic therapy (BT) in ankylosing spondylitis
(AS) has substantially benefited patients with inadequate response to con-
ventional therapy. However, it is known patients with inadequeate
response to a 1st BT have worse response to 2nd and further lines.
Objectives: To analyze the effectiveness of BT in biologic-naïve and bio-
logic-experienced real-world AS patients, measuring response through
change in activity indexes (ASDAS-CRP and BASDAI) and percentage of
low activity and inactive disease at 12 months.
Methods: Data were obtained from BIOBADASER III, an ongoing obser-
vational longitudinal multicenter cohort of patients with rheumatic diseases
treated with BT or targeted synthetic DMARDs. Patients were divided into
2 groups, according to their state before entering the study: BT-naïve
(BTn) receiving their 1
st
BT, and BT-experienced (BTe) receiving their 2
nd
or further BT; regardless of the specific drug they received. Disease
activity indexes (DAI) were collected at baseline and after 12 months of
BT; mean and SD was calculated for each group and interpreted accord-
ing to ASDAS disease activity states and, since not established, analo-
gous categories previously used for BASDAI (<2 inactive, 2 <4 low, 4
<6 high, 6 very high)
1
. Clinical response was assessed by ASDAS
improvement cut-offs (1.1 clinically important improvement (CII), 2
major improvement (MI)) and BASDAI CII (1.1)
2
, BASDAI change (D)
2 or BASDAI50.
Results: 846 patients, (29.3% women, mean age 47.6 years) were
included, 422 BTn and 424 BTe. Mean DAI results (table 1): at baseline,
AS had high disease activity by BASDAI (>4) and ASDAS (>2.1 to
<3.5). At 12 months, disease activity was low on both groups (BAS-
DAI<4, ASDAS >1.3 to <2.1), reaching BASDAI CII; DBASDAI2 was
only achieved in BTn. No group reached BASDAI50. ASDAS CII was
reached in all groups, but MI was not seen. Percentage of patients
achieving low disease activity and inactive disease are summarized at
table 2, being overall higher for the BTn compared to the BTe group.
Table 1. Mean disease activity indexes evolution
Activity
index
Biologic-naïve (BTn) Biologic-experienced (BTe)
Baseline
(SD)
12 months
(SD)
DBaseline
(SD)
12 months
(SD)
D
BASDAI 5.5 (2.0)
n=422
3.2 (1.0)
n=287
2.3 5.6 (2.3)
n=424
3.9 (2.3)
n=244
1.7
ASDAS-
PCR
3.2 (1.4)
n=120
1.7 (1.0) n=64 1.5 3.4 (1.5)
n=95
2.0 (0.9) n=50 1.4
Table 2. Percentage of low disease activity and inactive disease by BASDAI and ASDAS
Disease activity
states
n,% achieved at 12 months on
BTn
n,% achieved at 12 months on
BTe
BASDAI low activity 120, 41.8% 72, 29.5%
BASDAI inactive
disease
73, 25.4% 58, 23.8%
ASDAS low activity 21, 32.8% 11, 22%
ASDAS inactive
disease
23, 35.9% 15, 30%
Conclusion: The mean disease activity on patients starting biologic ther-
apy is high. A clinically important improvement is met after 12 months of
therapy, irrespectively of the index used or the prior use of biologics.
The delta in DAI is bigger in the biologic-naïve group who receive the
1
st
BT. The biologic-naïve group also reaches a higher percentage of low
disease activity and inactive disease. Further analysis is needed to see if
these tendencies remain after separating the groups per type of biologic
drug.
Scientific Abstracts Friday, 14 June 2019 879
on September 30, 2020 by guest. Protected by copyright.http://ard.bmj.com/Ann Rheum Dis: first published as 10.1136/annrheumdis-2019-eular.214 on 27 June 2019. Downloaded from
REFERENCES:
[1] Ramiro S, et al. Ann Rheum Dis 2014;73:1455-61.
[2] Kviatkovsky MJ, et al. J Rheumatol 2016;43:1680-6.
Acknowledgement: We thank the BIOBADASER group
Disclosure of Interests: None declared
DOI: 10.1136/annrheumdis-2019-eular.214
FRI0390 DRUG THERAPY OF ANKYLOSING SPONDYLITIS (AS)
DURING PREGNANCY IN REAL CLINICAL PRACTICE
Zuleykhan Gandaloeva, Olga Krichevskaya, Tatiana Dubinina. Federal State
Budgetary Scientific Institution “Research Institute of Rheumatology named after V.
A.Nasonova”,Moscow,RussianFederation
Background: The emergence of new drugs for the treatment of AS and
improvement of life quality of patients led to an increase in the number
of pregnancies and births in women with AS. However, the prescription
of medication during pregnancy is still a difficult decision for both doctors
and patients, and the unreasonable abolition of therapy can lead to
increased activity of the AS.
Objectives: was described the frequency of use of various groups of
drugs before and during pregnancy, determine the relationship between
the abolition or change in the mode of taking nonsteroidal anti-inflamma-
tory drugs (NSAIDs) and the dynamics of back pain.
Methods: the survey involved 86 women with AS, having pregnancies
that ended in childbirth, not earlier than 2016. The average age is 34.0
± 5.8 years and the average duration of the AS is 120 ± 73.5 months.
The median term of delivery is 39 [38; 40] weeks, the weight of new-
borns is 3241.1 ± 484.6 g. During pregnancy, 58 (67.4%) women noted
deterioration of health. Among them: increased back pain in the first tri-
mester was 66.7%, in II –84.6%, in III –72.2%.
Results: Before pregnancy, NSAIDs were taken by more women (63.4%)
as compared to taking in a month of conception (37.2%) and taking
during gestation (in trimesters - 25.6%; 34.8%; 9.3%, respectively), p
<0.05 in both cases. “On demand”, NSAIDs were taken before preg-
nancy by 41.8% of women, at conception - 37.5%, in trimesters —
50%, 40% and 25%, respectively. There was a tendency for more fre-
quent increase of back pain during pregnancy in women who abolished
NSAIDs in the month of conception, or switched to “on demand”(65%),
compared with taking NSAIDs daily (50%). Patients who took NSAIDs
“on demand”in the first trimester (group 1), more often noted deteriora-
tion of health in the second trimester - 34.6%, compared with patients
constantly taking NSAIDs (group 2) - 18.2%. In addition, patients in
group 1, as well as women who didn’t take NSAIDs in the first trimes-
ter, more often complained of back pain (54.6% and 53.1%) during ges-
tation compared with patients in group 2 (36.4%). Group 1 patients in
the second trimester noted increased back pain during pregnancy in
83.3%, whereas group 2 patients - in 58.3% (p<0.01).Glucocorticoids
were taken more often during pregnancy (16.3%; 20.9%; and 22.1% -
in trimesters) than before (7%) and at conception (9.3%), p<0.01 in
both cases. Sulfasalazine before pregnancy was taken by 16% of
women, at conception - 8%, during pregnancy - 3.5% (p<0.01 in both
cases). Before pregnancy, only 12.8% of women received biological
therapy; at the time of conception (adalimumab, etanercept) –6.9%, in
I and II trimesters –by 2.3% (p<0.01).
Conclusion: During pregnancy and the month of conception, the number
of women receiving NSAIDs, sulfasalazine, biological therapy, decreases
compared to the period before pregnancy. Glucocorticoids in preparation
for pregnancy and gestation are prescribed more often than before preg-
nancy. Withdrawal of NSAIDs or switch to mode “on demand”in the first
trimester is associated with an increase in the frequency of back pain
during pregnancy, but due to discrepant data on the safety of continuous
use of NSAIDs in the first trimester, correction of therapy with the pre-
scription of low-risk drugs is necessary.
Disclosure of Interests: None declared
DOI: 10.1136/annrheumdis-2019-eular.6750
FRI0391 NETAKIMAB IMPROVES PATIENT-RELATED
OUTCOMES IN PATIENTS WITH RADIOLOGICAL AXIAL
SPONDYLOARTHRITIS: RESULTS FROM RANDOMISED
PHASE 3 TRIAL (ASTERA)
Inna Gaydukova
1
,VMazurov
1
, Shandor Erdes
2
, Tatiana Dubinina
2
,
Olga Nesmeyanova
3
, Elena Ilivanova
4
,AlenaKundzer
5
, Nikolaj Soroka
6
,
Ekaterina Dokukina
7
, Anna Eremeeva
7
, Ekaterina Chernyaeva
7
,RomanIvanov
7
.
1
Mechnikov North-Western State Medical University, St-Petersburg, Russian
Federation;
2
Nasonova Research Institute of Rheumatology, Moscow, Russian
Federation;
3
Regional Clinical Hospital, Chelyabinsk, Russian Federation;
4
Leningrad Region Clinical Hospital, St-Petersburg, Russian Federation;
5
Healthcare Institution Municipal Clinical Hospital No. 1, Minsk, Belarus;
6
Scientific
and Practical Center of Surgery, Transplantology and Hematology, Minsk, Belarus;
7
JSC BIOCAD, St-Petersburg, Russian Federation
Background: chronic pain, stiffness, fatigue and limited spinal mobility sig-
nificantly affect quality of life (QoL) in patients (pts) with axial spondyloar-
thritis (axSpA). There is increasing evidence that IL-17 blockade is highly
effective in this pts’population and show benefits in terms of multiple
patient-reported outcomes (PROs) in both non-radiological (nr) and radio-
logical (r) axSpA.
Objectives: To evaluate early effects of netakimab (NTK) on PROs in pts
with active r-axSpA, based on data of 16-week observation from ongoing
phase 3 ASTERA study (NCT03447704).
Methods: ASTERA is a phase 3 international double-blind placebo(PBO)-
controlled clinical study. After completion of screening 228 eligible adult
pts with r-axSpA (mNew York criteria, 1984), which remained active
(BASDAI 4.0) despite the standard non-steroidal anti-inflammatory drugs
(NSAIDs), were randomly assigned (1:1) to receive 120 mg NTK or pla-
cebo (PBO) at Week (Wk) 0, 1, 2 and then q2wk through Wk 16. After
Wk 16 all patients will continue/be switched to receive NTK up to week
52. PROs were total back pain (10-item numerical range scale), BASDAI,
BASFI. Work productivity and QoL were also assessed by Work Produc-
tivity and Activity Impairment (WPAI) and 36-item Short Form Health Sur-
vey (SF-36), respectively.
Results: Baseline characteristics were similar between treatment arms.
The mean age at baseline was 39.14±9.99 years, 75.88% of patients
were male and the mean symptoms duration was 4.3±4.48 years. All
patients had active (mean BASDAI: 6.21±1.55) r-axSpA, 76.8% of patients
were naïve to any biological treatment. Mean total back pain score at
baseline was 6.7±1.6 in NTK group and 6.8±1.5 in PBO arm. At Wk1
the difference in total back pain score between study arms became stat-
istically significant (Figure 1). At Wk 16 use of NTK was associated with
statistically significant improvements from baseline in BASDAI (-2.8 vs
0.2, p<0.0001), BASFI (-0.9 vs 0.9, p<0.0001) and physical component of
SF36 (6.3 vs. -2.6, p<0.0001) (Figure 2). WPAI response in NTK arm
was significantly better at Wk 16, as compared with PBO (Table 1).
Conclusion: NTK in treatment of patients with r-axSpA showed rapid
improvement in PRO, WP and QoL and was accompanied with improve-
ment in physical function and disease activity.
Table 1. Change in WPAI at week 16 (medians; upper and lower quartiles)
Parameter NTK (n=114) PBO (n=114)
Baseline Change from
baseline to Wk16
Baseline Change from
baseline to Wk16
% work time missed
due to health
0 [0; 18.4] 0 [-11,1; 0] 0 [0;
15.8]
0 [0; 29.9]
% impairment while
working due to health
50 [30;
70]
-80 [-40; 0] 50 [40;
70]
10 [-10; 20]
% overall work
impairment due to
health
55.1 [40;
84]
-15.6 [-40; 0] 60 [50;
75]
1.2 [-10.3; 20]
% activity impairment
due to health
60 [40;
80]
-20 [-40; - 10] 60 [50;
70]
0 [-10; 20]
Figure 1. Total back pain score within 16 weeks of ASTERA study (means) (* P<0.05 for
the comparison with placebo).
880 Friday, 14 June 2019 Scientific Abstracts
on September 30, 2020 by guest. Protected by copyright.http://ard.bmj.com/Ann Rheum Dis: first published as 10.1136/annrheumdis-2019-eular.214 on 27 June 2019. Downloaded from
