1061: Safety and Tolerability of Aminaphtone in Systemic Sclerosis Patients: A Four-year Follow-up

andrea cere, Emanuele Gotelli, Lercara Adriano, Carmen Pizzorni, sabrina Paolino, Alessandri Elisa, Maurizio Cutolo and Alberto Sulli, Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy

Background/Purpose: Recent studies proved that aminaphtone is an effective treatment for Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). Laser Speckle Contrast Analysis (LASCA) further demonstrated an increased peripheral blood perfusion in aminaphtone treated patients [1,2]. This drug is currently available only in a few countries.

The aim of this study was to evaluate long-term the profile of safety and tolerability of aminaphtone in SSc patients.

Methods: Seventy SSc patients taking aminaphtone were enrolled and followed for four years (mean disease duration 8±7 years, mean age 61±10 years). They met the 2013 EULAR/ACR criteria for SSc and started aminaphtone treatment due to active RP.

Patients were taking the following concomitant drugs: aspirin, immunomodulators, cyclic intravenous iloprost, endothelin receptor antagonists; none was taking either selexipag or phosphodiesterase type 5 inhibitors. Aminaphtone therapy was assessed and possible drug-related side effects were recorded. Patients were routinely evaluated with the Raynaud Condition Score (RCS) to assess disease severity, as well as by blood exams.

Results: The mean follow-up was 49±11 months. Aminaphtone was orally administered at 75 mg twice daily, as per our clinical practice. Six patients (8,6%) reported headache as side effect and had to reduce aminaphtone posology to 75 mg once daily, while maintaining clinical benefits. No other side effects related to the drug were observed during the follow-up. Seven patients (10%) increased the posology to 75 mg three times daily due to poor effectiveness, and further seven patients (10%) increased the posology to 75 mg three times daily only during the colder months of the year. Conversely, thirty-five patients (50%) reduced the treatment to 75 mg once daily during the warmest months of the year due to partial remission of symptomatic RP.

A subjective improvement of Raynaud's symptoms, as assessed by the RCS, was already evident after 2 months of treatment in fifty-six patients (80%). Globally, patients referred a clinical improvement followed by a stabilization of Raynaud's symptoms.

During the follow-up, blood tests did not reveal any significant alteration.

Conclusion: During an average follow-up of four years, aminaphtone showed a good tolerability and safety profile along with sustained efficacy in SSc patients with secondary RP, without any disabling or serious side effect. A randomized controlled trial is desirable to better evaluate the efficacy of the drug over time.

References: 1. Parisi S et al. Am J Int Med. 2015;3:204–209. 2. Ruaro B et al. Front Pharmacol. 2019;10:293.

Disclosures: a. cere, None; E. Gotelli, None; L. Adriano, None; C. Pizzorni, None; s. Paolino, None; A. Elisa, None; M. Cutolo, Bristol-Myers Squibb(BMS), Boehringer-Ingelheim, Amgen; A. Sulli, LABORATORY BALDACCI SPA.