Primary Sjögren's Syndrome Clinical Trial
Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often
involving the central and peripheral nervous systems. Fifteen to twenty percent of patients
with the primary Sjögren's syndrome have neurological complications involving the peripheral
nervous system. Although some patients have large fiber neuropathy, around forty percent of
patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic
studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms,
some have been shown to have small fiber neuropathy (SFN). A recent study proved that more
than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.
The aim of this study will be to investigate the occurrence of small fiber neuropathy in
patients with pSS and neuropathic pain with normal electromyographic studies and to determine
the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or
auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is
a valuable tool to diagnose small fiber neuropathy and the method has been widely validated.
A skin biopsy will be performed in patients and control and will allow quantification of
small fiber density in skin sample along with measurement of sweat gland innervation.
Moreover, pathophysiological studies will be carried on in order to evaluate the causal
relationship between cellular and humoral inflammation and small fiberneuropathy.
Recent studies have pointed out the inconstant efficacy of both corticosteroid and
immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small
fiber neuropathy in these patients may help designing new therapeutic strategies.
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