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Abstract Number: 2580

A Comparison of Baseline Characteristics and Real-Life Effectiveness of Anti-TNF Therapy in Non-Radiographic Axial Spondyloarthritis Versus Ankylosing Spondylitis – a Single Center Cohort Study

Sarka Forejtova1, Jakub Zavada2, Michal Uher3, Karel Hejduk3 and Karel Pavelka4, 1Rheumatology, Institute of Rheumatology, Prague, Czech Republic, 2Charles University, Prague, Czech Republic, 3Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic, 4Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS), anti-TNF therapy and axial spondyloarthritis

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Session Information

Session Title: Spondyloarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment III

Session Type: Abstract Submissions (ACR)

Background/Purpose:

The recent Assessment of SpondyloArthritis international Society (ASAS) classification criteria proposed the concept of axial spondylarthritis (axSpA) to enable earlier treatment not only for patients fulfilling the modified New York (mNY) criteria for ankylosing spondylitis (AS), but also  for patients with non-radiographic axSpA (nr-axSpA).  There is uncertainty whether the benefit of anti-TNF therapy in patients with nr-axSpA is as impressive as in patients with established AS, especially when the ASAS criteria and therapeutic recommendations are applied in real clinical practice.

Methods: Our aim was to compare the baseline characteristics and one year clinical outcome of anti-TNF therapy in axSpa patients prospectively followed in a large academic rheumatology center.  This was a single center study conducted within the national biologics registry. To get reimbursement for anti-TNF therapy, all AS patients had to have high baseline disease activity (defined as BASDAI >4, and CRP > 10 mg/l).  ASAS classification criteria were applied retrospectively using the data recorded in the source clinical documentation. All patients with inflammatory back pain fulfilling either ASAS criteria for nr-axSpA, or mNY criteria for AS starting treatment with anti-TNF therapy were included in the analysis.

Results:  At baseline, patients with nr-axSpa had shorter disease duration, higher number of swollen peripheral joints, and were more often treated with glucocorticoids and synthetic DMARDs. There were no statistical significant differences in the effect of biologics on the improvement in BASDAI, BASFI, EUROQOL and spinal pain during first 12 months of treatment. Also, the QALY area under the curve was no different between both groups. There was significantly larger improvement in CRP in the group of AS patients, while in the nr-axSpA group there was greater change in the improvement of SJ, but these differences in range of change appeared to be caused by the ceiling effect of uneven baseline values of these measures.

Conclusion: Although there were some important baseline differences between both cohorts, the amount of improvement in axial symptoms, physical function and quality of life   during the first 12 months of the anti-TNF treatment was similar in nr-axSpA and AS patients.

Acknowledgements: This work was supported by project of MHCR for conceptual development of research organization 023728

Table: Baseline characteristics and outcome of 12 months of anti-TNF therapy in AS and nr-axSpA patients

 

AS (N=275)

nr-axSpA(N=39)

p-value

Female

n (%)

68 (24.7 %)

15 (38.5 %)

0.069

Age (years) at baseline

mean (SD)

38.0 (10.4)

37.9 (12.2)

0.713

HLA B27 positivity

n (%)

252 (92.0 %)

32 (84.2 %)

0.117

Disease duration prior to start of anti-TNF therapy

of anti-TNF therapy (years)

mean (SD)

9.0 (8.6)

4.9 (6.3)

<0.001

Peripheral joint involvement ever

n (%)

94 (34.3 %)

24 (64.9 %)

<0.001

Concomitant glucocorticoids  at baseline

n (%)

23 (8.4 %)

11 (28.2 %)

<0.001

Concomitant DMARD at baseline

n (%)

57 (20.7 %)

21 (53.8 %)

<0.001

CRP (mg/l) at baseline

mean (SD)

25.5 (21.2)

21.9 (30.1)

0.013

CRP (mg/l) at 12 months

mean (SD)

5.3 (8.2)

4.8 (8.9)

0.232

CRP  (mg/l) change per year

mean (SD)

-19.9 (22.2)

-17.3 (30.3)

0.013

BASDAI at baseline

mean(SD)

6.1 (1.9)

5.8 (2.5)

0.841

BASDAI at 12 months

mean (SD)

2.1 (1.7)

1.8 (1.5)

0.256

BASDAI change per year

mean (SD)

-4.1 (2.3)

-4.2 (2.8)

0.909

BASFI at baseline

mean (SD)

4.9 (2.2)

4.1 (2.7)

0.115

BASFI at 12 months

mean (SD)

2.6 (2.1)

1.4 (1.2)

0.002

BASFI change per year

mean (SD)

-2.3 (2.1)

-2.7 (2.7)

0.607

HAQ at baseline

mean (SD)

0.9 (0.5)

0.8 (0.6)

0.449

HAQ at 12 months

mean (SD)

0.5 (0.5)

0.4 (0.3)

0.636

HAQ change per year

mean (SD)

-0.4 (0.5)

-0.5 (0.5)

0.719

Spinal pain (BASDAI Q2 0-100) at baseline

mean (SD)

70.5(22.1)

63.5(27.4)

0.256

Spinal pain (BASDAI Q2 0-100) at 12 months

mean (SD)

27.9 (22.4)

24.0 (20.5)

0.392

Spinal pain (BASDAI Q2 0-100) change per year

mean (SD)

-44.9 (28.0)

-40.0 (33.8)

0.414

Number of swollen joints/44 at baseline

mean  (SD)

1.8 (3,4)

3.4 (4.8)

0.002

Number of swollen joints/44 at 12 months

mean (SD)

0.3 (1.2)

1.1 (2.5)

0.002

Number of swollen joints/44 change per year

mean (SD)

-1.3 (3.0)

-2.6 (4.8)

0.055

EUROQOL

mean (SD)

0.4 (0.3)

0.4 (0.3)

0.699

EUROQOL

mean (SD)

0.8 (0.2)

0.7 (0.2)

0.462

QALY EQ-5D (area under the curve)

mean (SD)

0.7 (0.2)

0.7 (0.1)

0.525

Mann-Whitney U test, Pearson Chi-Square test (or Fisher exact test when frequencies are low) and Gamma test were used when comparing continuous, nominal and ordinal variables, respectively.


Disclosure:

S. Forejtova,
None;

J. Zavada,
None;

M. Uher,
None;

K. Hejduk,
None;

K. Pavelka,
None.

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