Abstract
ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of ≥5 (Brief Pain Inventory [BPI]). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]). No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Δ -11.5 ± 3.04 versus Δ -2.9 ± 3.34 [standard error of the mean]). Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF-36 (Δ -23.4 ± 5.5 and Δ -14.6 ± 3.9, respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms.
Highlights
Sarcoidosis is an inflammatory disease that targets many tissues
In common with a number of other conditions, for example, Sjogren disease [1], one prominent clinical manifestation is a dysfunction of small nerve fibers that occurs in a patchy, non–length-dependent manner
The small fiber neuropathy screening list (SFNSL) score showed a time-dependent, significant difference between treatment trated, 60% of placebo patients experienced an improvement from baseline at wk 4 between 1 and 5 points, versus 83% of ARA 290 patients
Summary
In common with a number of other conditions, for example, Sjogren disease [1], one prominent clinical manifestation is a dysfunction of small nerve fibers that occurs in a patchy, non–length-dependent manner (small fiber neuropathy [SFN]). The clinical sequela of these changes is the development of sharp shock-like or burning pain, characterized by dysesthesia and allodynia, and loss of cutaneous sensation and autonomic function. A questionnaire [4] was designed and validated in Dutch patients with sarcoidosis (the small fiber neuropathy screening list [SFNSL]) and is useful in following the clinical course of SFN
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