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Abstract Number: 1526

Stable Clinical and MRI Response In Patients With Early Axial Spondyloarthritis After 3 Years Of Continuous Treatment With Etanercept, Data Of The Esther Trial

In-Ho Song1, Kay-Geert A. Hermann2, Hildrun Haibel1, Christian Althoff3, Denis Poddubnyy4, Joachim Listing5, Anja Weiss6, Ekkehard Lange7, Bruce Freundlich8, Martin Rudwaleit9 and Joachim Sieper4, 1Medical Department I, Rheumatology, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany, 2Radiology, Charité Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany, 3Radiology, Charite Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany, 4Charité Universitätsmedizin Berlin, Berlin, Germany, 5German Rheumatism Research Center, Berlin, Germany, 6German Rheumatism Research Centre, Berlin, Germany, 7BU Specialty Care, Pfizer Pharma AG, Berlin, Germany, 8University of Pennsylvania, Philadelphia, PA, 9Endokrinologikum, Berlin, Germany

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS), Clinical research, etanercept, magnetic resonance imaging (MRI) and spondylarthritis

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Session Information

Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment: II

Session Type: Abstract Submissions (ACR)

Background/Purpose:     < style="text-align: justify;">In patients with early axial spondyloarthritis (SpA) with a disease duration of < 5 years and evidence of active inflammation on whole-body magnetic resonance imaging (wb-MRI) in the spine and/or sacroiliac joints (SIJ) at baseline [1] the long-term efficacy of etanercept (ETN) was assessed over three years.

.

Methods:

In the previously reported ESTHER trial axial SpA patients were treated with ETN (n= 40) versus sulfasalazine (SSZ) (n= 36) in the first year [1]. All patients who were not in remission at week 48 (n=48) were either continuously treated with ETN, or sulfasalazine treatment was switched to ETN treatment. We analysed the clinical and MRI response in he pooled data set of patients who were continously treated with ETN for 3 consecutive years. Data were analysed as observed.

Results:

In the pooled group of patients treated continously over 3 years with ETN (n= 60) the BASDAI decreased from 5.7 (standard deviation 1.3) to 2.0 (1.5), the ASDAS from 3.4 (0.8) to 1.2 (0.7). Also mean values for MRI spine and sacroiliac joint scores showed a significant decrease (table 1). ASAS partial remission after three years of ETA was reached by 43%, ASDAS inactive disease by 60% (table 1).

Conclusion:

There was a constant and sustained clinical response in patients with early axial SpA patients treated with ETN over 3 years. The response in this early axial SpA cohort seems to be better compared to established AS cohorts with a longer disease duration (> 10 years) where BASDAI50 response rates of 47% after 3 years of infliximab treatment [3] and ASAS40 and ASAS partial remission rates of 49% and 27%, respectively after 4 years of etanercept treatment [4] were reported.

Table 1: Long-term efficacy over 3 years in patients with early axial spondyloarthritis treated with etanercept. Data at baseline (BL), after one year of treatment with etanercept, after two years and after three years of treatment with etanercept.

 

ETN, Baseline

Data after one year of treatment with ETN

Data after two years of treatment with ETN

Data after three years of treatment with ETN

BASDAI (0-10)

5.7 (1.3)

2.5 (2.0)

2.1 (1.8)

2.0 (1.5)

BASFI (0-10)

4.4 (2.1)

2.0 (2.0)

1.6 (1.7)

1.4 (1.3)

ASDAS (0- …)

3.4 (0.8)

1.6 (0.8)

1.4 (0.9)

1.2 (0.7)

CRP (mg/l)

10.5 (13.6)

3.5 (4.6)

3.6 (5.5)

2.9 (5.5)

MRI Spine Score (-69)

1.6 (3.4)

NA

0.7 (1.4)

0.9 (1.8)

MRI SI-joint Score (-24)

4.6 (6.3)

NA

3.5 (6.1)

3.3 (6.0)

ASAS40, %

NA

68.4%

67.4%

75.0%

ASAS PR, %

NA

35.1%

53.5%

42.5%

ASDAS inactive disease, %

NA

38.9%

53.7%

60.0%

BASDAI50, %

NA

64.9%

65.1%

72.5%

Data shown as mean values (standard deviation) unless otherwise stated. Abbreviations: ETN: etanercept; ASAS PR: ASAS partial remission; NA: not applicable; BASDAI : Bath Ankylosing Spondylitis Disease Activity Index ; ASDAS : Ankylosing Spondylitis Disease Activity Score ; ASAS : Assessment of SpondyloArthritis international Society; MRI: magnetic resonance imaging; SI-joint: sacroiliac joint;

 

  1. Song I.-H. et al. Ann Rheum Dis. 2011;70(4):590-596.
  2. Song I.-H. et al. Ann Rheum Dis. 2012;71(7):1212-1215.
  3. Braun J. et al. Rheumatology 2005;44:670–676
  4. Davis JC et al. Ann Rheum Dis. 2008;67(3):346-353

Disclosure:

I. H. Song,

Pfizer, Merck Sharp Dohme/Schering Plough, AbbVie ,

5;

K. G. A. Hermann,
None;

H. Haibel,

Pfizer, Merck Sharp Dohme/Schering Plough, AbbVie,

5;

C. Althoff,
None;

D. Poddubnyy,

Merck Sharp Dohme/Schering Plough, AbbVie,

5;

J. Listing,
None;

A. Weiss,
None;

E. Lange,

Pfizer Inc,

3;

B. Freundlich,

Pfizer Inc,

9;

M. Rudwaleit,

Pfizer, Merck Sharp Dohme/Schering Plough, AbbVie, UCB,

5;

J. Sieper,

Pfizer, Merck Sharp Dohme/Schering Plough, AbbVie, UCB,

5.

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