AB0739 Aminaphtone tolerability and safety in scleroderma patients: a four-year follow-up

Abstract

BackgroundRecent studies show that Aminaphtone is effective in the treatment of Raynaud’s phenomenon (RP) symptoms in patients with systemic sclerosis (SSc), and an increase in peripheral blood perfusion was demonstrated by Laser speckle contrast analysis in treated patients (1,2). Unfortunately, the drug is only available in a few countries.ObjectivesTo evaluate long-term tolerability and safety of Aminaphtone in SSc patients with secondary RP.MethodsSeventy SSc patients (EULAR/ACR criteria) (mean disease duration 8±7 years, mean age 61±10 years) who started Aminaphtone treatment due to active RP were enrolled and followed for at least 4 years. Patients were also taking various concomitant treatments, including immunomodulators, cyclic intravenous iloprost, endothelin receptor antagonists and aspirin. None was taking sildenafil or selexipag. Survival of Aminaphtone in therapy was assessed along with possible drug-related side effect. The Raynaud condition score (RCS) to asses disease severity and blood examinations were routinely performed.ResultsThe mean follow-up of patients was 49±11 months. Aminaphtone was orally administered at 75 mg twice daily, as standard initial posology in our clinical practice. During the follow-up, six patients (8,6%) referred headache as side effect and had to reduce Aminaphtone posology to 75 mg per day, while maintaining clinical benefits. No other side effect related to the drug was observed during the follow-up. Seven patients increased the posology to 75 mg three times daily due to poor effectiveness, and further seven patients increased the posology to 75 mg three times daily only during the colder months of the year. Conversely, thirty-five patients reduced the dosage to 75 mg once daily only during the hottest months of the year, due to partial remission of the RP. During follow-up, blood tests did not reveal any significant alteration ascribable to Aminaphtone. A subjective improvement of Raynaud’s symptoms (assessed by the RCS) was already evident after 1-2 months of treatment in fifty-six patients (80%). Globally, the patients referred a sustained improvement followed by stabilization of Raynaud’s symptoms during the follow-up.ConclusionDuring an average observation period of four years, Aminaphtone showed a good tolerability and safety profile along with sustained efficacy in patients with SSc-related RP, without disabling or serious side effects. A randomized controlled trial for Aminaphtone use in the management of SSc-related RP is desirable to better assess the clinical 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. 2019. Front Pharmacol 10:293.Disclosure of InterestsANDREA CERE: None declared, Emanuele Gotelli: None declared, Adriano Lercara: None declared, Carmen Pizzorni: None declared, Sabrina Paolino: None declared, Elisa Alessandri: None declared, Maurizio Cutolo Grant/research support from: Bristol Myers Squibb, Celgene, Pfizer, Boehringer Ingelheim, Alberto Sulli: None declared

A Systematic Review of Aminaphtone from Pathophysiology to Clinical Applications: Focus on New Rheumatological Acquisitions

“…Improvement of RCS was clinically significant with Aminaphtone treatment, and the drug showed a good tolerability and safety profile (no changes in routine blood tests). The only adverse event reported was headache (8.6% of cases), and no patient discontinued treatment due to intolerance during a four-year follow-up [50].…”

“…Of relevance, several authors have reported satisfactory tolerability of Aminaphtone, although manuscripts regarding the long-term safety of the drug are lacking. Although we decided to eliminate conference abstracts from our systematic review, we report only a preliminary work in this regard [50]. Seventy SSc patients with symptomatic secondary RP were treated with Aminaphtone (average 75 milligrams twice a day) in addition to concomitant vasodilating therapy, including ET receptor antagonists and intravenous iloprost [50].…”

“…Although we decided to eliminate conference abstracts from our systematic review, we report only a preliminary work in this regard [50]. Seventy SSc patients with symptomatic secondary RP were treated with Aminaphtone (average 75 milligrams twice a day) in addition to concomitant vasodilating therapy, including ET receptor antagonists and intravenous iloprost [50]. Improvement of RCS was clinically significant with Aminaphtone treatment, and the drug showed a good tolerability and safety profile (no changes in routine blood tests).…”