OP0336 modulation of genetic markers of fibrosis and skin score in patients with systemic sclerosis following administration of tadalafil
Abstract
Background: Tadalafil is an approved drug for the treatment of Raynaud's phenomenon and digital ulcers in systemic sclerosis (SSc). From our previous in vitro work, we have observed anti-fibrotic potential of tadalafil in SSc dermal fibroblasts. Herein we have carried out an in vivo study to evaluate its anti-fibrotic effect on skin fibrosis in SSc. Objectives: To compare the change from baseline, in modified Rodnan skin score (mRSS) and mRNA expression of pro-fibrotic genes at 6 months in SSc patients receiving standard of care plus tadalafil vs those receiving standard of care but not tadalafil. Methods: Adult patients fulfilling the 2013 ACR classification criteria for SSc who were tadalafil naïve or have received it more than 6 months prior were recruited in this open label randomized prospective observational study. A 4 mm 2 forearm lesional skin punch biopsy was obtained at baseline and after 6 months of treatment. mRSS and expression of transcripts of nine profibrotic genes including cartilage oligomeric matrix protein (COMP), thrombospondin-1 (THS1), interferon induced 44 (IFI44), sialic acid binding immunoglobulin like lectin 1 (SIGLEC1), connective tissue growth factor (CTGF), collagen type1 α1 and α2 (COL1A1 and COL1A2), actin α2 (ACTA2) and tenascin C (TN-C) were recorded. Data analysis was done using student's t test and Wilcoxon signed rank test. Results: Initially 45 patients were enrolled, however 4 patients were lost to follow up and one patient died…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 45 participants or records.
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