Open access rheumatology : research and reviews · 2026
Safety and Microvascular Effect of Four-Year Aminaphtone Administration in Systemic Sclerosis Patients.
СтатьяНазвание и аннотация: Перевод в очереди
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Campitiello Rosanna, Sulli Alberto, Hysa Elvis, Pizzorni Carmen, Cutolo Maurizio, Paolino Sabrina, Gotelli Emanuele
Аннотация
BACKGROUND: Endothelial and microvascular damage is a hallmark of systemic sclerosis (SSc), an autoimmune connective tissue disease characterized by progressive skin and organ fibrosis. Aminaphtone (3-Methyl-1,4-dioxo-1,4-dihydro-naphthalen-2-yl-amino-benzoate) is a synthetic molecule used to treat microvascular disorders. Nailfold videocapillaroscopy (NVC) is the most reliable non-invasive method for assessing microvascular status and disease progression in SSc patients.
AIM: To evaluate long-term safety and potential beneficial effects of aminaphtone on microcirculation in SSc.
METHODS: Seventy-six SSc patients (68 females, 8 males; mean age 69 ± 15 years) fulfilling the 2013 ACR/EULAR criteria and presenting Raynaud's phenomenon received aminaphtone (75 mg twice daily) in addition to stable standard therapy (ST). Forty age- and sex-matched SSc patients treated with ST alone served as controls. Side effects were monitored every six months. NVC was performed at baseline and after 1 and 4 years, using the Cutolo classification ("Early", "Active", "Late" patterns) to evaluate microvascular damage progression.
RESULTS: Aminaphtone showed a high long-term retention rate (89.5%) over four years. Eight of 76 patients (10.5%) discontinued treatment due to mild transient intolerance or poor compliance; no serious adverse events were reported. NVC patterns remained stable in 91% of treated patients. Compared with controls, aminaphtone-treated patients showed a slower transition from "Active" to "Late" NVC pattern (120 ± 64 vs 50 ± 26 months, p = 0.05). Linear mixed-effects modelling showed a significantly slower capillary density decline in the aminaphtone group over 48 months (p < 0.05) in both "Early" and "Active" scleroderma pattern subgroups. On multivariate linear regression, this effect was independent of age, disease phenotype, and concomitant therapies.
CONCLUSION: Aminaphtone appears safe and well tolerated during long-term treatment in SSc patients with secondary Raynaud's phenomenon. The stability of NVC scleroderma patterns and the independent protective effect on capillary loss suggest a potential adjunctive role of aminaphtone in limiting microvascular damage progression when added to ST in SSc.
AIM: To evaluate long-term safety and potential beneficial effects of aminaphtone on microcirculation in SSc.
METHODS: Seventy-six SSc patients (68 females, 8 males; mean age 69 ± 15 years) fulfilling the 2013 ACR/EULAR criteria and presenting Raynaud's phenomenon received aminaphtone (75 mg twice daily) in addition to stable standard therapy (ST). Forty age- and sex-matched SSc patients treated with ST alone served as controls. Side effects were monitored every six months. NVC was performed at baseline and after 1 and 4 years, using the Cutolo classification ("Early", "Active", "Late" patterns) to evaluate microvascular damage progression.
RESULTS: Aminaphtone showed a high long-term retention rate (89.5%) over four years. Eight of 76 patients (10.5%) discontinued treatment due to mild transient intolerance or poor compliance; no serious adverse events were reported. NVC patterns remained stable in 91% of treated patients. Compared with controls, aminaphtone-treated patients showed a slower transition from "Active" to "Late" NVC pattern (120 ± 64 vs 50 ± 26 months, p = 0.05). Linear mixed-effects modelling showed a significantly slower capillary density decline in the aminaphtone group over 48 months (p < 0.05) in both "Early" and "Active" scleroderma pattern subgroups. On multivariate linear regression, this effect was independent of age, disease phenotype, and concomitant therapies.
CONCLUSION: Aminaphtone appears safe and well tolerated during long-term treatment in SSc patients with secondary Raynaud's phenomenon. The stability of NVC scleroderma patterns and the independent protective effect on capillary loss suggest a potential adjunctive role of aminaphtone in limiting microvascular damage progression when added to ST in SSc.