Background/Purpose: The progressive endothelial damage is one of the hallmarks of systemic sclerosis (SSc), an autoimmune connective tissue disease characterized by organ fibrotic involvement. Aminaphtone is a synthetic moleculeregistered for clinical use to treat microvascular disorders that interferes with the expression of vasoactive mediators released by activated endothelial cells [1,2].Nailfold videocapillaroscopy (NVC) is a reliable and non-invasive tool to assess microvascular damage and is considered a morphological biomarker for detection of disease progression in SSc [3].The aim of this retrospective study was to evaluate the safety data and the possible beneficial effects on microcirculation induced by aminaphtone when added to standard therapy (ST) in SSc patients during a four-year follow-up.

Methods: Seventy-five Caucasian SSc patients (7 males and 68 females, mean age 68±15 years; mean disease duration 13±7 years) (according to 2013 EULAR/ACR criteria) with secondary Raynaud’s phenomenon (RP) started aminaphtone treatment (75 mg BID) in addition to ST. NVC was performed at baseline, after 1 year and 4 years of treatment, adopting the SSc-pattern classification (“Early”, “Active”, “Late” NVC SSc-patterns) [4]. The timing of transition between capillaroscopic patterns in SSc treated with aminaphtone and ST was compared to SSc patients only treated with ST [5]. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice, and all patients provided written informed consent.

Results: No life-threatening side effects were reported in the SSc cohort during 4 years of treatment. However, 10% of patients discontinued aminaphtone treatment due to mild intolerance due to well-known adverse events (headache 2.7%, itching 1.3%, others 6%). NVC SSc-patterns in SSc patients treated with aminaphtone remained stable during the observational time frame in 72% of cases, in 8 of the patients (14.7%) was observed a dynamic transition from “Early” to “Active” or from “Active” to “Late” pattern (2.7% and 10.7%, respectively). Of note, SSc patients treated with aminaphtone showed a slower timing of transition between NVC patterns compared to the control group with ST alone (from “Early” to “Active” 57.6 ± 37.4 months vs 28 ± 20 months; P= 0.12 and from “Active” to “Late” 48± 1.0 months vs 36 ± 29 months; P =0.42), even if this difference was not statistically significant.

Conclusion: Aminaphtone seems to be a safe and well tolerated drug in SSc patients with secondary RP during long term treatment. NVC scleroderma-pattern stability over time suggests a possible additional therapeutical effect as a concomitant treatment to ST in SSc patients with RP, but the suggestion deserves further investigations.

1. Gotelli E et al. Pharmaceuticals (Basel) 2023;16(4):569.2. Ruaro B et al. Front Pharmacol 2019;10:293. 3. Cutolo M et al. Nat Rev Rheumatol 2010;6, 578–87. 4.Smith V et al. Autoimmun Rev. 2020;19(3):102458. 5. Sulli A, et al. Arthritis Rheum. 2012;64(3):821-25

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-microvascular-effects-of-long-term-treatment-with-aminaphtone-in-systemic-sclerosis-patients-a-retrospective-analysis/