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

BackgroundThe pathogenesis of systemic sclerosis (SSc) is thought to result from interactions between epigenetic features and environmental factors, leading to the onset and progression of the disease in genetically susceptible patients (1). Case reports of women with silicone breast implants who developed SSc have been published, but case-control and prospective studies in connective tissue diseases often failed to find an increased risk of SSc associated with silicone cosmetic surgery (2,3). These studies have several limitations, including heterogeneous cohorts of enrolled patients not selective for SSc, non-homogeneous disease duration or disease stage at study entry. For these reasons, the possible effect of silicone implants as immune adjuvants is highly suspected but remains unclear (4).ObjectivesRetrospective study of SSc patients, to find out who developed SSc after silicone cosmetic surgery.MethodsThe clinical files of 140 female patients with systemic sclerosis were retrospectively evaluated and clinical data collected.ResultsFive patients showing a history of silicone cosmetic surgery (3.6%) before SSc development were identified. The brief clinical histories of the five patients are below reported, showing very similar outcomes after silicone implant. 1. TC 47-year-old female underwent cosmetic breast prosthesis: twelve months later she experienced Raynaud’s phenomenon (RP) and diffuse cutaneous SSc after 10 further months; antinuclear antibodies were positive with a speckled and nucleolar pattern, but specific SSc-related autoantibodies negative. 2. LS 28-year-old female underwent cosmetic breast prosthesis: twenty-two months later RP appeared and anticentromere antibodies (ACA) positive aggressive diffuse SSc was diagnosed one year later. 3. PJ 38-year-old female underwent cosmetic breast prosthesis: eleven months later she experienced RP and after 10 further months, aggressive diffuse cutaneous SSc; antinuclear antibodies were positive with a speckled patter, but specific SSc-related autoantibodies were negative. 4. CM 58-year-old female who underwent cosmetic lip silicone application: one year later she complained of simultaneous onset of RP and very aggressive diffuse cutaneous SSc with anti-topoisomerase positivity; she died during follow-up. 5. BS 33-year-old female who underwent cosmetic breast prosthesis: twenty months later she complained of RP and after ten further months, limited cutaneous SSc with ACA positivity; SSc clinical condition partially improved and its progression stopped after prosthesis removal. Globally, after silicone implant, RP occurred in a mean time of 15±5 months and SSc in 23±8 months.ConclusionThis study reports a prevalence of 3.6% of silicone cosmetic surgery before SSc onset, interestingly with a close and similar temporal association between silicone implant and disease development. This finding suggests a possible role of silicone in SSc pathogenesis (ASIA syndrome). Specifically addressed large clinical studies or big-data studies need to rule out this matter.References[1]Denton C, et al. Lancet 2017; 390: 1685–99.[2]Marie I et al. Semin Immunopathol 2015; 37:463–473.[3]Coroneos CJ et al. Ann Surg. 2019 Jan;269(1):30-36.[4]Watad A et al. Lupus. 2017; 26:675-681.Disclosure of InterestsAdriano Lercara: None declared, Alberto Sulli: None declared, Carmen Pizzorni: None declared, Emanuele Gotelli: None declared, Sabrina Paolino: None declared, ANDREA CERE: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Celgene, Pfizer, Boehringer-Ingelheim