Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
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<strong>Protocol</strong> Version 3 14/01/2013<br />
medic<strong>in</strong>e e.g., abnormal creat<strong>in</strong><strong>in</strong>e or liver enzymes represent important blood biomarkers of tissue<br />
pathology, but they are not <strong>in</strong>formative of the respective specific renal or liver pathology. More<br />
importantly, as seen <strong>in</strong> breast cancer, biomarkers of prognosis and therapeutic response are<br />
expressed only at tissue level (e.g. ER, HER) 20 .<br />
We have strong evidence emerg<strong>in</strong>g from the MRC-funded Pathobiology of Early Arthritis Cohort<br />
(PEAC) <strong>in</strong>itiative (220 recruited, target 300 by April 2012 - http://www.peacmrc.mds.qmul.ac.uk/<strong>in</strong>dex.php)<br />
that RA patients can be classified <strong>in</strong>to at least 3 histomorphological<br />
patterns e.g. Fibroblast (pauci-immune), Lymphoid (B cell rich) and Myeloid (rich <strong>in</strong><br />
monocytes but poor <strong>in</strong> B cells). We have also evidence that the PEAC histopathology patterns<br />
correspond to different transcriptomic signatures. More important still, we have strong pilot data <strong>in</strong><br />
a biopsy-based <strong>study</strong> of 21 RA patients (<strong>anti</strong>-TNF-ir) that a significantly higher proportion of<br />
patients with synovial B cell-rich pattern respond to Rituximab compared with a synovial B cellspoor<br />
pattern and vice versa no-response is associated with absence/scarce B cells (chi squared<br />
p
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