Article
An objective automated measurement of fluorescence-signal intensities in Fluorescence-Optical Imaging technique can classify early non-response of antiTNF treatment in Psoriatic Arthritis patients – interims analysis of the XPLORE-study
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Authors
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Michaela Köhm
- Abteilung Rheumatologie, Universitätsklinikum Frankfurt & Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main
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Tanja Rossmanith
- Klinische Forschung, Fraunhofer IME, Projektgruppe Translationale Medizin und Pharmakologie (TMP), Frankfurt am Main, Frankfurt am Main
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Ulf Henkemeier
- Klinikum der Johann Wolfgang Goethe-Universität, Zentrum der Inneren Medizin, Rheumatologische Ambulanz, Frankfurt/Main
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Peer Aries
- Rheumatologie im Struensee-Haus, Hamburg
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Rieke H.-E. Alten
- Schlossparkklinik, Akademisches Lehrkrankenhaus der Charité - Universitätsmedizin Berlin, Innere Medizin II, Rheumatologie, klinische Immunologie und Osteologie, Berlin
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Hans-Eckhard Langer
- RHIO (Rheumatologie, Immunologie, Osteologie) Düsseldorf, Düsseldorf
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Harald Louis Burkhardt
- Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik II, Rheumatologie, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main
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Frank Behrens
- CIRI am Klinikum der Johann Wolfgang Goethe-Universität, Rheumatologie, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main
| Published: | August 29, 2016 |
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Outline
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Background: Psoriatic arthritis (PsA) is a chronic inflammatory disorder associated with joint and musculoskeletal inflammation. After failure of NSAID and DMARD treatment, antiTNF therapy is started. In daily practice response is measured by clinical examination and calculated using composite indices (e.g. DAS28). Earliest after 3 months a decision is made for response. Feasible and robust biomarkers for early prediction of therapeutic response are missing.
Methods: Fluorescence optical imaging technique (FOI) is used as a method for detection of changes in microvascularisation of the hands as inflammation marker. An automated computer-based reading of the disease activity (DACT) is used as objective method to display overall fluorescence-signals and their intensities.
In a prospective multicentre study, the value of FOI in measurement of disease activity and sensitivity to change in PsA-patients (n=80) newly treated with antiTNF is investigated (XPLORE-study). In this interims analysis (n=13), early changes of fluorescence intensities (DACT at baseline to week 4) are measured and correlated to clinical response (achievement of low disease activity: DAS28 ≤ 3.2) after 12 weeks of treatment.
Results: Mean age at baseline was 55 years, mean DAS28 4.6, mean PASI 5.6, mean values for SJC 6.4 and TJC 12.9 (66/68 joint count); female and male patients with 1:1 distribution were included. All patients were negative for ACPA and rheumatoid factor.A value of at least 45% improvement in fluorescence intensities after 4 weeks of treatment was correlated to the achievement of low disease activity (DAS28 ≤ 3.2) at week 12. The treatment regime of most of those patients who did not reach this value was changed already after 12 weeks. Only one patient without improvement up to this threshold was qualified as responder by DAS28 change of -3.0.
Conclusion: FOI has high sensitivity to detect early changes after treatment initiation with antiTNF. A threshold of at least 45% of improvement in fluorescence intensities was detected to show already after 4 weeks a high discriminative value for prediction of later clinical response. Only one patient was qualified as responder although he did not meet the criteria. In this case, disease activity might be driven by other factors than inflammatory arthritis (only 1 SJC/TJC at baseline).
