POS0882 AMINAPHTONE LONG-TERM TREATMENT IN SYSTEMIC SCLEROSIS

Abstract

Background:Aminaphtone has been used since many years to treat microvascular disorders. Aminaphtone seems to improve clinical symptoms of Raynaud’s phenomenon (RP), either primary or secondary to systemic sclerosis (SSc) by increasing peripheral blood perfusion as assessed by Laser speckle contrast analysis (1).Objectives:To evaluate long-term survival and tolerability of Aminaphtone in SSc patients with secondary RP.Methods:Eighty SSc patients (mean age 64±12 years; mean disease duration 9±8 years) treated with Aminaphtone due to active RP were enrolled (ACR/EULAR 2013 criteria). Patients were taking also various concomitant treatments, including aspirin, cyclic intravenous iloprost, immunomodulators, endothelin receptor antagonists. SSc patients performed periodic clinical and laboratory assessments on average every four months per our clinical practice. Duration of Aminaphtone administration, side effects, and self-assessment of Raynaud Condition Score (RCS) with a scale from 0 (absence of pain) to 10 (maximal pain) were retrospectively assessed.Results:The observation period was between twelve and seventy months (mean 36±19 months). Aminaphtone was administered at 75 mg twice daily, as standard initial posology per our clinical practice. During the follow-up, five patients (6.2%) referred headache as side effect: three of them had to reduce Aminaphtone posology to 75 mg per day, while maintaining clinical benefits; two patients had to stop the treatment. No other side effects related to the drug appeared during the treatment period, and repeated blood tests did not reveal any significant alteration ascribable to Aminaphtone. After 3 months of treatment sixty-six patients (83%) referred a subjective improvement of RP (RCS 3.6±0.8, vs baseline RCS 7.4±0.8, p=0.032), whereas fourteen patients (17%) were clinically unsatisfied (RCS 6.1±0.4, p=0.12). In this last group of patients, Aminaphtone posology was increased to 75 mg three times a day with a satisfactory amelioration in further nine patients (94% of total) (RCS 4.0±0.6, p=0.04), while five patients (6.2%) definitively discontinued therapy for subjective ineffectiveness within six months. Patients referred a sustained improvement of RCS along the observational period (36±19 months) (last RCS 3.6±0.7 vs baseline, p=0.031).Conclusion:During an average observation period of three years, Aminaphtone showed a good tolerability profile along with sustained efficacy in 94% of patients with SSc-related RP, without disabling side effects. The absence of a placebo-control group, the retrospective design limit the results, and a randomized controlled trial for Aminaphtone use in the management of SSc-related RP is needed.