Background/Purpose: Current treatments for Raynaud’s phenomenon (RP) have limited efficacy, which was mainly demonstrated by physician/patient reported outcomes. Aminaphtone is a vasoactive drug recently suggested to improve RP symptoms and among other mechanism is also able to down-regulate endothelin-1 production by endothelial cells (1-3). The aim of this study was to evaluate the clinical symptoms related to RP and skin blood perfusion changing, during aminaphtone treatment in primary RP (PRP) and secondary RP (SRP) patients, during a six-month follow-up.

Methods: Forty-six patients with active RP were enrolled in November 2015 after informed consent (11 PRP, mean age 49±19 SD years, mean RP duration 6±3 years; 35 SRP in systemic sclerosis (SSc) (ACR/EULAR criteria) (mean age 61±17 SD years, mean RP duration 11±9 years). Aminaphtone was administered off label 75 mg twice daily in addiction to current treatments (patients were on stable drug regimen from at least two months, and they did not modify it during follow-up). Blood perfusion was measured, in perfusion units (PU), in all patients by Laser speckle contrast analysis (LASCA) (4,5) at the level of fingertips, periungual areas, dorsum and palm of hands and face at baseline (W0), after one (W1), four (W4), twelve (W12) and twenty-four (W24) weeks of treatment. Raynaud condition score (RCS) and both Raynaud’s attack frequency and duration were also assessed at the same times. Forthy-six patients with RP (9 PRP, mean age 56±12 SD years, mean RP duration 8±4 years; 37 SRP in SSc, mean age 63±11 SD years, mean RP duration 12±10 years) were also enrolled as control group, and evaluated at T0 and T24. Statistical analysis was performed by non parametric tests.

Results: A progressive statistically significant decrease of RCS (median at W0, W1, W4, W12, W24 respectively: 7, 6, 4, 4, 4; p<0.0001), Raynaud’s frequency (median 2, 2, 1, 1, 1 attacks/day; p<0.0001) and duration (median: 20, 20, 10, 4, 4 minutes; p<0.0001) was observed from W0 to W12. A progressive statistically significant increase of blood perfusion was observed from W0 to W12 in all skin areas (median PU at W0, W1, W4, W12, W24 respectively: fingertips 55, 88, 101, 107, 98; periungual areas 44, 88, 91, 92, 92; dorsum of hands 38, 61, 71, 75, 75; palm of hands 56, 85, 89, 94, 82; face 127, 138, 144, 159, 129; p<0.001 for all areas). No further statistically significant amelioration of either RP symptoms of or blood perfusion was observed from W12 to W24. The results were similar for both PRP and SRP patients (p=0.4). In the control group no statistically significant changes regarding blood perfusion from W0 to W24 were observed (p=0.9 for all areas).

Conclusion: Aminaphtone treatment improves RP-related clinical symptoms and rapidly increases skin blood perfusion, also in SSc patients. A randomized blind clinical trial need to confirm these results.

References. 1. Parisi S, et al. Am J Int Med 2015;3;204-9. 2. Scorza R, et al. Drugs R D 2008;9:251-7. 3. Salazar G, et al. Eur J Pharmacol. 2016;782:59-69. 4. Ruaro B, et al. Ann Rheum Dis. 2014;73:1181-5. 5. Cutolo M, et al. Nat Rev Rheumatol 2015;11:569-71.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/aminaphtone-ameliorates-clinical-symptoms-and-increases-skin-blood-perfusion-in-patients-with-both-primary-and-secondary-raynaud-phenomenon-a-six-month-open-study/