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Abstract Number: 2855

Non-Response to Antitnf Treatment in Psoriatic Arthritis Can be Predicted By an Objective Automated Measurement of Fluorescence-Signal Intensities in Fluorescence-Optical Imaging Technique – the First Interims Analysis of the Xplore-Study

Michaela Koehm1,2, Tanja Rossmanith3, Ulf Henkemeier4, Peer Aries5, Rieke Alten6, Hans-Eckhard Langer7, Harald Burkhardt8,9 and Frank Behrens1,9, 1Clinical Research, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main, Germany, 2Rheumatology, Goethe-University Frankfurt, Frankfurt/Main, Germany, 3Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt, Germany, 4Centre of Innovative Diagnostics and Therapeutics Rheumatology/Immunology at Goethe-University, Frankfurt, Germany, 5Rheumatologie im Struenseehaus, Hamburg, Germany, 6Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, 7RHIO (Rheumatology, Immunology, Osteology) Duesseldorf, Duesseldorf, Germany, 8Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main, Germany, 9Rheumatology, Goethe-University Frankfurt, Frankfurt, Germany

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: imaging techniques, psoriatic arthritis and treatment

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Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:
Psoriatic arthritis (PsA)
is a chronic inflammatory disorder. AntiTNF-therapy
is initiated after failure of NSAID and DMARD-treatment. Up to 30-40% of the
patients are primary not responding adequately to the induced therapy. In daily
practice, response is assessed by improvement of disease activity measured by
clinical examination and using composite indices (ACR20 response or DAS28).
Earliest after 3 months, a decision for response is made. Feasible and robust
biomarkers for early prediction of therapeutic response are still missing.

Methods:
Fluorescence optical
imaging technique (FOI) is used as method for detection of changes in
vascularisation of the hands as inflammatory marker. ICG is injected as
fluorescence colour agent, stimulated by light in a specific wave length and
recorded by a specific camera in the device. Overall fluorescence-signals and
their intensities are measured by an automated computer-based reading of the
disease activity (DACT). In a prospective multicentre study, value of FOI in
measurement of disease activity and sensitivity to change in newly treated PsA
patients (n=80) with Etanercept is investigated (XPLORE-study). In this first
interims analysis (n=13), early changes of DACT (baseline to week 4) are
measured and correlated to the clinical response (achievement of at least low disease
activity: DAS28 ² 3.2) after 12 weeks of treatment.

Results:
All of the patients (mean
age 55 years, female:male 1:1, mean DAS28 4.6, mean
PASI 5.6, mean SJC 6.4, mean TJC 12.9 (66/68 joint count) at baseline) who did
not reach at least 45% improvement in fluorescence intensities after 4 weeks of
treatment did not achieve the threshold of low disease activity (DAS28 ² 3.2)
at week 12. The treatment regime of most of those patients was changed after
week 12. Only one patient without the described improvement was qualified as
responder by DAS28 change of -3.0.

%DACT

change BL to W4

DAS28 BL

DAS28 W12

SJC BL

SJC W12

TJC BL

TJC W12

Treatment Change

after 12 weeks [y/n]

01

-59

5.0

2.7

9

2

9

0

n

02

-50

2.4

2.3

6

4

4

4

n

03

>+100

5.1

4.2

5

3

22

4

y

04

-49

3.5

1.0

2

1

3

1

n

05

-14

4.3

3.5

5

8

7

11

y

06

>+100

5.9

5.5

5

4

16

19

y

07

>+100

5.8

3.6

3

4

25

0

n

08

0

4.5

1.5

1

0

1

0

n

09

-65

5.9

2.8

18

0

18

0

n

10

>+100

4.5

4.2

2

2

10

12

n

11

-35

4.1

3.8

9

20

1

8

y

12

-51

4.3

2.6

19

9

5

15

y

13

>+100

4.5

4.8

9

4

18

57

n

Conclusion:
Preliminary data of the
first interims analysis of the XPLORE study illustrate high sensitivity in patients
newly treated with Etanercept-therapy. Achievement of improvement of at least
45% in fluorescence intensity shows already after 4 weeks a high discriminative
value for prediction of later clinical response at week 12. Only one patient
was qualified as responder although he did not meet the criteria for response
in fluorescence signalling. In this case, disease activity seems to be driven
by other factors than inflammatory arthritis (only 1 SJC/TJC at baseline).
Early change in fluorescence signalling seems to be a promising marker for
prediction of clinical response in newly initiated biological treatment.


Disclosure: M. Koehm, Pfizer Inc, 2,MSD; Pfizer, 5,Janssen Pharmaceutica Product, L.P., 8; T. Rossmanith, Pfizer Inc, 2; U. Henkemeier, None; P. Aries, Pfizer Inc, 8,Pfizer Inc, 2; R. Alten, Pfizer Inc, 5,Pfizer Inc, 2,Pfizer Inc, 8; H. E. Langer, Pfizer Inc, 2; H. Burkhardt, AbbVie Deutschland; Pfizer; BMS; UCB; Chugai, 5,Pfizer Inc, 2; F. Behrens, AbbVie Deutschland GmbH & Co KG; Chugai; Pfizer; Roche, 5,Pfizer Inc, 8.

To cite this abstract in AMA style:

Koehm M, Rossmanith T, Henkemeier U, Aries P, Alten R, Langer HE, Burkhardt H, Behrens F. Non-Response to Antitnf Treatment in Psoriatic Arthritis Can be Predicted By an Objective Automated Measurement of Fluorescence-Signal Intensities in Fluorescence-Optical Imaging Technique – the First Interims Analysis of the Xplore-Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/non-response-to-antitnf-treatment-in-psoriatic-arthritis-can-be-predicted-by-an-objective-automated-measurement-of-fluorescence-signal-intensities-in-fluorescence-optical-imaging-technique-the-first/. Accessed .
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