Scientific Abstracts

Thursday, 13 June 2013

where the initial two observers disagreed whether an article had mainly clinical
or basic science content.
Results: 231 articles were surveyed. 137 (59%) were of clinical and 94 (41%)
of basic science content. The Table shows the number of articles that contained
the word limit and/or a limit.der in the discussion sections of these articles as
well as the presence of any form of self critique which included the presence of
the word limit or a limit. der. The statistically significant differences between
the two kinds of articles persisted when each journal was assessed separately
(data not given). In 4/231(1.7%) instances the word limit or a limit.der was
used in a different context.
Table. The frequency of the word limit (s) and the presence of any self
critique

Clinical; n=137

Basic; n=94

Total; n=231

FG

HY

FG

HY

FG

HY

Limit and/or a
limit.der +

83
(61)

79 (58)

11
(12)

11(12)

94
(41)

90
(39)

Any self critique

+

94
(69)

100
(73)

19
(20)

29
(31)

113
(49)

129
(56)

parenthesis indicate percentages p<0.0001 for all comparisons between clinical and basic articles and for either observer
Conclusions: Around one half of the original articles in our leading
rheumatology journals lacked self critique. This was significantly more
pronounced in basic science manuscripts. We propose that such self critique
should be highlighted perhaps even more in the scientific authorship guidelines
especially in those related to basic science, including animal work. Also a
higher priority should be given to its presence in peer review.
References: 1. Altman DG, Schulz KF, Moher D, et al, CONSORT Group.Ann
Intern Med 2001;134:66394.
2. von Elm E, Altman DG, Egger M, et al, STROBE Initiative. Lancet
2007;370:14537.
Disclosure of Interest: H. Yazici: None Declared, F. Gogus: None Declared, F.
Esen: None Declared, Y. Yazici Grant/research support from: BMS, Genentech,
Centocor, Celgene, Consultant for: Abbott, BMS, Celgene, Genentech,
Horizon, Janssen, Pfizer, UCB

THU0540

HOW GOOD IS THE COVERAGE AND HOW ACCURATE

ARE EXPOSURE DATA IN BIOLOGICS REGISTERS?
AN ASSESSMENT OF THE SWEDISH BIOLOGICS
REGISTER (ARTIS)

H. Wadstrom1, J. K. Eriksson1, M. Neovius1, J. Askling1,2 on behalf of the

ARTIS study group. 1Clinical Epidemiology Unit, 2Rheumatology Unit,
Karolinska Institutet, Stockholm, Sweden
Background: Biologics registers have been established in many countries.
However, the usefulness of these registers and the interpretation of results
from analyses based on such data both hinge upon an understanding of
the coverage and representativity of eligible patients, and on the accuracy
and validity of the data entered. The Swedish setting with virtually complete
national registers that can be linked together offers a possibility to compare
clinical register data against de facto drug prescriptions filled.
Objectives: To assess the coverage of ARTIS and the accuracy of the
registered information on biologics exposure.
Methods: Through cross-reference of ARTIS to virtually complete national
registers on prescribed subcutaneous and oral drugs, nonprimary outpatient
care visits, and death/residency, we assessed: (i) the coverage of ARTIS in
terms of first time initiators of subcutaneous anti-TNF therapies 2006-2009, the
validity of (ii) the registered start- and stop dates, (iii) false positive treatment
registrations, and (iv) the accuracy of the registered information on concomitant
DMARDs at start of the biological treatment. For each assessment we defined
coverage and accurate using algorithms and pre-specified time-windows,
and performed separate assessments for patients with register-identified RA
and AS/SpA/PsA (requiring 1 visit in nonprimary outpatient care in 2006-2009
listing RA and AS/SpA/PsA, respectively). The biologics used in these analyses
were the then available subcutaneous biologics (adalimumab and etanercept).
Results: 8048 patients with RA and 3743 patients with AS/SpA/PsA had at
least one prescription filled of a subcutaneous anti-TNF therapy 2006-2009. Of
these, 94% of the patients with RA, and 84% of those with spondyloarthropaties
were also found in ARTIS with a corresponding treatment. There was no age/
sex difference between those captured by ARTIS and those not. Allowing a
90-day window, 93% of all the anti-TNF therapy prescriptions filled occurred
between a start- and a stop date in ARTIS. Conversely, 2% of the registered
treatments in ARTIS lacked a corresponding drug prescription. With respect
to the first prescription filled of etanercept/adalimumab in relation to the
registered start date in ARTIS, 5% of the patients had the first prescription >60
days prior, and 5% >60 days after the registered start date. 10% of patients
had at least one prescription filled of the anti-TNF therapy >90 days after the
registered stop date in ARTIS. 75% of all patients who started anti-TNF therapy
in combination with a DMARD also had a DMARD prescription within 90 days
after treatment start.
Conclusions: Taking the routine clinical care setting and inevitable
uncertainties such as non-compliance into account, we observed a high
coverage and validity of ARTIS data on biologics exposure, both for RA and for
spondyloarthropaties. Combining data from ARTIS, including also clinical data
that cannot be derived from other registers, with prescription data from national

347

registers offers a high quality measurement of de facto treatment in studies of

subcutaneous biologics.
Acknowledgements: ARTIS has agreements with Abbott, BMS, Merck, Sobi,
AstraZeneca, Pfizer, and Roche
Disclosure of Interest: None Declared

THU0541

ASSOCIATION BETWEEN PERIODONTITIS AND THE

RISK OF ETANERCEPT WITHDRAWAL IN ANTI-TNFNAVE RHEUMATOID ARTHRITIS PATIENTS:
A NATIONWIDE POPULATION-BASED COHORT STUDY

H.-H. Chen1, D.-Y. Chen1, N. Huang2, K.-L. Lai1, Y.-M. Chen1, Y.-J. Chou3,
P. Chou4, C.-H. Lin5. 1Division Of Allergy, Immunology And Rheumatology,
Department Of Internal Medicine, Taichung VeteransGeneral Hospital,
Taichung, 2Institute of Hospital and Health Care Administration, 3 Institute of
Public Health, 4 Institute of Public Health and Community Medicine Research
Center, National Yang Ming University, Taipei, 5Department of Medical
Research, Taichung Veterans General Hospital, Taichung, Taiwan, Province
of China
Background: Given the epidemiologic and immunologic findings, it is
hypothesized that that PD may be a risk factor not only for the initiation but
also for the progression of RA. To date, only a small study has shown that PD
may also influence the anti-TNF treatment response in patients with RA.
Objectives: To investigate the association between periodontitis (PD) and
etanercept survival in anti-tumor necrosis factor (anti-TNF)-nave patients with
rheumatoid arthritis (RA).
Methods: This retrospective nationwide population-based cohort study
identified 3359 anti-TNF-nave RA patients (age at diagnosis 16 years) in
whom etanercept (ETN) treatment was initiated using administrative data. Two
variables regarding PD exposure were used for analysis: PD during the 5 years
before ETN administration (history of PD) and PD between ETN start date and
stop date (concurrent PD). The association between PD and ETN withdrawal
was quantified by calculating hazard ratios (HRs) with 95% confidence intervals
(CIs) using Cox proportional hazard regression analysis, after adjustment for
potential confounders.
Results: An interaction between concurrent PD and the drug survival time
was demonstrated. To avoid violating the assumption for the Cox proportional
regression model, analysis was stratified by concurrent PD. A history of
PD was associated with increased risk of ETN withdrawal in patients with
concurrent PD (HR, 1.27; 95% CI, 1.011.60) and those without concurrent PD
(HR, 1.17; 95% CI, 1.061.30). This association was stronger in the concurrent
PD group with more PD-related visits (5) during the 5 years before ETN
administration (RR, 1.62; 95% CI, 1.232.14). Concomitant methotrexate or
leflunomide administration had a protective effect on etanercept withdrawal in
patients without concurrent PD, but the effect was attenuated in patients with
concurrent PD.
Conclusions: A history of PD before ETN administration was associated with
an increased risk of ETN withdrawal in anti-TNF-nave RA patients.
References: 1Marotte H, Farge P, Gaudin P, et al. The association between
periodontal disease and joint destruction in rheumatoid arthritis extends the
link between the HLA-DR shared epitope and severity of bone destruction. Ann
Rheum Dis 2006;65:905-9.
2Ribeiro J, Leao A, Novaes AB. Periodontal infection as a possible severity
factor for rheumatoid arthritis. J Clin Periodontol 2005;32:412-6.
3Ortiz P, Bissada NF, Palomo L, et al. Periodontal therapy reduces the severity
of active rheumatoid arthritis in patients treated with or without tumor necrosis
factor inhibitors. J Periodontol 2009;80:535-40.
4 Savioli C, Ribeiro AC, Fabri GM, et al. Persistent periodontal disease
hampers anti-tumor necrosis factor treatment response in rheumatoid arthritis.
J Clin Rheumatol 2012;18:180-4.
Acknowledgements: We thank the members of the Bureau of National Health
Insurance, Department of Health, and the National Health Research Institutes
for providing and managing, respectively, the National Health Insurance
Research Database. This study was supported by grant TCVGH-1023805C
from Taichung Veterans General Hospital, Taiwan.
Disclosure of Interest: None Declared

THU0542

SCORES FOR PAIN AND FATIGUE EXPLAIN

VARIATION IN PATIENT GLOBAL STATUS AT
HIGHER SIGNIFICANCE THAN PHYSICAL FUNCTION
IN PATIENTS WITH RHEUMATOID ARTHRITIS
(RA), OSTEOARTHRITIS (OA), SYSTEMIC LUPUS
ERYTHEMATOSUS (SLE) AND GOUT SEEN IN USUAL
CLINICAL CARE

I. Castrejn1, Y. Yazici1, T. Pincus1. 1NYU Hospital for Joint Diseases, New

York, United States
Background: Patient global estimate of clinical status (PATGL) is one of 3
patient self-report measures in the rheumatoid arthritis (RA) core data set,
and often is the most sensitive measure to distinguish responses to active
treatment from placebo in RA clinical trials. PATGL has also been found an
informative measure in patients with rheumatic diseases other than RA. Pain
has been found most explanatory of PATGL in RA, but the relative contribution
of functional disability, pain and fatigue to explain PATGL in other rheumatic
diseases remains poorly characterized.

348

Scientific Abstracts

Thursday, 13 June 2013

Objectives: To analyze the significance of 3 self-report scores for functional

disability, pain and fatigue to explain variation in PATGL in patients with all
rheumatic diseases seen in a usual care rheumatology setting, and in subsets
with RA, OA, SLE, gout, and all other diagnoses.
Methods: All patients seen at a rheumatology clinical setting complete a
multidimensional heath assessment questionnaire (MDHAQ) at all visits,
which includes physical function in 10 activities; visual analog scales (VAS)
for pain, PATGL and fatigue; and demographic variables including age, formal
education level and gender. The data are recorded in a longitudinal Access
database, which was then transferred to STATA Version 11 for analyses. The
last available visit of each patient with complete data for all variables was
studied in a series of multivariate regressions to analyze the capacity of selfreport scores for functional disability, pain and fatigue as independent variables
to explain PATGL as the dependent variable in all patients and subgroups with
RA, OA, SLE, gout, and other diagnoses.
Results: Overall, 2565 patients had complete data, including 517 with RA,
319 OA, 281 SLE, 98 gout and 1350 other diagnoses. Each of the 3 variables
- functional disability, pain, and fatigue - independently explained patient
global estimate, with highest significance for pain, intermediate for fatigue, and
lowest (but significant) for functional disability. Pain was more dominant in RA,
while fatigue was of greater relative significance in OA, SLE, gout and other
diagnoses (Table). The R2 in these 4 models ranged from 0.570.76, indicating
robust explanation of variation in PATGL.
Beta coefficients (P values) and R2 values of regressions including functional disability, pain and
fatigue as possible explanatory variables for variation in patient global estimate (PATGL)

Diagnosis

Independent Variable
Functional
disability
Beta (P)

Pain
Beta (P)

Fatigue
Beta (P)

R2 of
model

All
patients

2565

0.20
(<0.001)

0.43
(<0.001)

0.34 (<0.001)

0.70

RA

517

0.21
(<0.001)

0.52
(<0.001)

0.25 (<0.001)

0.76

OA

319

0.23
(<0.001)

0.34
(<0.001)

0.33 (<0.001)

0.57

SLE

281

0.15
(0.002)

0.39
(<0.001)

0.38 (<0.001)

0.71

Gout

98

0.19
(0.034)

0.39
(<0.001)

0.36 (<0.001)

0.59

Other

1350

0.21
(<0.001)

0.41
(<0.001)

0.35 (<0.001)

0.70

Conclusions: Pain, fatigue, and functional disability each were independently

significant, in that order, to explain variation in PATGL; fatigue scores were less
prominent in RA compared to OA, SLE, and gout.
Disclosure of Interest: None Declared

THU0543

OBESITY AND OSTEOARTHRITIS IN CANADA:

PROJECTIONS FROM A MICROSIMULATION MODEL

J. A. Kopec1, E. C. Sayre2, P. Fines3, W. M. Flanagan3, C. Nadeau3, A.

Okhmatovskaia4, M. C. Wolfson5. 1University of British Columbia, Vancouver,
2
Arthritis Research Centre of Canada, Richmond, 3Statistics Canada, Ottawa,
4
McGill University, Montreal, 5University of Ottawa, Ottawa, Canada
Background: Osteoarthritis (OA) is the most common type of arthritis and,
because of its strong association with age, a growing health problem around
the world. A key modifiable risk factor for OA is body mass index (BMI).
Therefore, changes in the distribution of BMI in the population can be expected
to impact the incidence and, consequently, the prevalence of OA. However,
we do not know how much the prevalence of OA would change as a result
of changes in BMI. The question is important for estimating the benefits of
interventions targeting obesity as well as projecting the burden of OA.
Objectives: Our goal wasto project the prevalence of OA in Canada over
the next two decades, under a broad range of scenarios for changes in the
distribution of BMI.
Methods: We used a previously described Canadian micro-simulation model
of OA called POHEM-OA [1]. The model simulates individual life and health
histories for 25 million Canadians age 20+. Demographic and epidemiological
parameters relevant to BMI and OA were derived from Canadian vital statistics,
census data, national surveys, and administrative data in the province of British
Columbia (physician-diagnosed OA). Obesity prevalence and OA incidence
and prevalence rates were projected for the years 2001-2030. We considered
a base-case (no intervention) scenario and a range of counterfactual
(intervention) scenarios in which BMI for persons in selected BMI categories
was increased or decreased by 0.1 to 2 units per year, starting in 2011.
Results: In the base-case scenario, obesity (BMI30) prevalence in Canada
increased from 18.8% in 2010 to 25.9% in 2030, while OA prevalence rose
from 13.9 to 18.4%. Obesity was higher in men than in women in the basecase scenario, but became higher in women as a result of BMI-reducing
interventions. OA prevalence was higher in women than in men in all
scenarios. In the intervention scenarios, overall obesity rates in 2030 were
12.4%, 7.1%, and 1.8%, respectively, for a 0.3, 0.5 and 1 unit drop in BMI per
year in overweight and obese individuals. In these scenarios, OA prevalence
in 2030 reached 17.7%, 17.2% and 16.4%, respectively, a reduction of the
expected (base-case) growth in OA by 16-44%. In the extreme scenario,
in which obesity was virtually eliminated (drop in BMI by 2 units per year),

OA prevalence still increased over time, reaching 15.8% by 2030 (less than
half of the increase expected under the base-case scenario).In scenarios in
which obesity levels increased at a higher-than-expected rate, OA prevalence
increased faster, reaching 22.2% in 2030 in a scenario in which >90% of the
population were obese.
Conclusions: The increasing trend in OA prevalence in Canada is not highly
sensitive to small-to-moderate reductions in obesity. Larger reductions (>50%)
are likely to slow down the trend substantially, but not reverse it. Due to aging
of the population, OA will remain a major and growing health issue in Canada
over the next 2 decades, regardless of the course of the obesity epidemic.
References: 1. Kopec JA, Sayre EC, Flanagan WM, Fines P, Cibere J,
Rahman MM, Bansback NJ, Anis AH, Jordan JM, Sobolev B, Aghajanian J,
Kang W, Greidanus NV, Garbuz DS, Hawker GA, Badley EM. Development
of a population-based microsimulation model of osteoarthritis in Canada.
Osteoarthritis Cartilage. 2010;18(3):303-11
Acknowledgements: The study was supported by a grant from the Canadian
Institutes of Health Resaerch.
Disclosure of Interest: None Declared
Thursday, 13 June 2013

Rehabilitation ___________________________
THU0544

CLINICAL AND RADIOLOGIC ASSESSMENT OF

INTRA-ARTICULAR HYALURONIC ACID INJECTION
VERSUS ULTRASOUND IN MANAGEMENT OF PRIMARY
OSTEOARTHRITIS OF THE KNEE (A PROSPECTIVE
STUDY)

A. Allam1, N. M. El-Gazzar1, M. A.-S. El Sergany1, H. M. El Saadany1.

1
Physical Medicine,Rheumatology and Rehabilitation, Faculty of
medicine,Tanta University, Tanta, Egypt
Background: Osteoarthritis (OA), the most common form of arthritis, is a
chronic disease characterized by slow degradation of cartilage, pain, and
increasing disability.
Objectives: The aim of this work was to compare the effect of 2 commonly
used lines of treatment; intra-articular Hyaluronate & ultrasound when
combined with static exercises in the treatment of primary OA of the knee.
Methods: 30 patients with symptomatic primary OA of the knee participated
in a randomized, blinded (outcome assessors), gender-matched prospective
study involving clinical and radiologic assessment. They were diagnosed
according to American College of Rheumatology criteria.
Exclusion criteria included: Severe OA, Secondary causes of OA, other causes
of knee pain (traumatic and inflammatory), OA with knee effusion, recent intraarticular steroid injection one month before the start of the study.
Degree of pain was assessed by Visual Analogue Scale (VAS) during walking and at rest and Lequesnes Pain Function Index (LPFI). Also, tenderness,
morning stiffness and medial Joint Space Width (JSW) were measured for
allpatients before, after treatment and after 2 months follow up. Patients were
not allowed to use any other medications during duration of the study.
Patients were classified into 2 groups according to the line of treatment: Group
: 15 patientsreceived intra-articular Sodium hyaluronate (Hyalgan) single injection per week for five weeks(1). Group : 15 patients received continuous
ultrasonic waves of 1 MHz frequency and 1 watt/cm2 power(2), applied for 10
minutes to the knee every other day for five weeks. All patients practiced home
exercise therapy (static) for the knee 5times/day.
Results: Clinically, IA hyaluronate combined with exercises improved VAS
during walking, at rest, tenderness, morning stiffness and LPFI (P<0.001) after
treatment and at the follow up compared with the results before treatment.
Similarly, continuous ultrasound combined with exercises improved VAS during
walking, at rest, tenderness, LPFI (P<0.05) and morning stiffnesss (P<0.001)
after treatment and at the follow up compared with the results before treatment.
It was observed that improvement in clinical parameters inhyaluronate
groupwas higher thanultrasound group(P<0.05). Radiologically, There was
no statistically significant difference as regard measurement of medial JSW
for either groups (P>0.05). However there was statistically non-significant
stoppage of progression of JS loss in patients received hyaluronate observed
after treatment but not maintained after 2 months.
Conclusions: Our study demonstrated the efficacy of both lines of treatment
(IA Hyaluronate and continuous ultrasound) combined with exercises in
improving pain and function in patients with mild to moderate OA knee. Both
immediately after treatment and maintained for 2 months. Inter-group analysis
showed superiority of IA hyaluronate.
References: 1.Neustadt DH (2006): Intra-articular injections for
osteoarthritis of the knee.Cleve Clin J of Med;73(10):897-911.
2.zgnenel L, Aytekin E and Durmuolu G (2009): Double-Blind Trial
of Clinical Effects of Therapeutic Ultrasound in Knee Osteoarthritis.Ultrasound
Med Biol;35(1):44-49.
Disclosure of Interest: None Declared