POS0988 INCREASED FREQUENCY OF ANTI-RNA POLYMERASE 3 ANTIBODIES IN PATIENTS WITH SYSTEMIC SCLEROSIS AND SILICONE BREAST IMPLANTS: A MULTICENTRE STUDY FROM THE INTERNATIONAL EUSTAR COHORT

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Background: Systemic Sclerosis (SSc) is a heterogeneous systemic autoimmune disease, in which distinct disease subsets can be identified with autoantibodies. In a large EUSTAR study including > 4,000 SSc patients, anti-RNA polymerase III (anti-RNAP3) was positive in 4.5% and a distinct clinical phenotype was defined, including association with malignancies synchronous to disease onset and specifically breast cancer [1]. Noteworthy, one study from Italy [2] and one from Japan [3] reported a specific association of silicone breast implants (SBI) with anti-RNAP3 positivity in SSc female patients, raising the possibility of a new clinical association of this autoantibody. Objectives: To analyse the clinical and laboratory characteristics of female SSc patients with SBI implanted before the disease onset, and to compare them with female SSc patients without SBI. Methods: International case-control study within the EUSTAR network (CP-117), including SSc female patients with SBI implanted before SSc onset for any reason (cases) and 2-3 SSc female patients without SBI (controls) matched for cutaneous subset, age at onset (±5 years) and disease duration (±2 years). Specifically, data regarding the indication for SBI implantation and possible documented SBI rupture (cases) and data on breast cancer and synchronous breast cancer (cases and controls) were recorded. Results: 41 SSc patients with SBI (cases) and 119 matched controls were collected from 13 centres. Among 41 cases, the majority had SBI implanted for cosmetic reasons (82.9%) and had diffuse cutaneous involvement (dcSSc, 58.5%), with anti-RNAP3 positivity detected in 31.7%. Anti-RNAP3+ patients, as compared to anti-RNAP3- had a tendency toward a higher frequency of documented SBI rupture (7/13 vs 7/28, p:0.089). As compared to 119 matched controls, patients with SBI had a higher frequency of anti-RNAP3 positivity (31.7% vs 14.3%, p:0.020, [OR 2.78, 95% CI 1.20-6.42]). No difference in the rate of breast cancer was observed, with no cases of breast cancer synchronous in both groups. Clinical characteristics were globally similar in cases and controls, except for the lower prevalence of clinically relevant arrythmias and higher prevalence of ever smoker in SBI patients (Table 1). Interstitial lung disease (ILD) was slightly less frequent in SBI+ (46.3% vs 60.0%, p:0.144) with NSIP being the most frequent pattern in both groups. A tendency toward a better functional outcome in terms of pFVC% at last visit was observed for SBI+ ILD patients (p:0.087). Therapeutic approach was also similar in the two groups (Table 2). Conclusion: In this multicentre international cohort, patients with SSc and SBI implanted before disease onset showed dcSSc in more than half of cases and had a higher rate of anti-RNAP3 positivity as compared to the expected frequency and to matched controls. SBI were mainly implanted for cosmetic reasons and no cases of synchronous breast cancer were detected in both groups, highlighting that the association with anti-RNAP3 with SBI is independent from the one with breast cancer previously documented. Clinical features were similar to those of matched controls, except for lower prevalence of arrhythmias in cases. Further enrichment of the cohort will allow subgroup analysis of SBI patients. REFERENCES: [1] Lazzaroni MG. J Rheumatol 2017; 44:639-47. [2] Lazzaroni MG. Clin Exp Rheumatol 2020; 39 (4), 25-28. [3] Saigusa R. J Dermatol 2016; 43:808-10. Acknowledgements: GILS (Gruppo Italiano Lotta Sclerodermia) is kindly acknowledged for supporting the study with a grant. Disclosure of Interests: Maria Grazia Lazzaroni Boehringer Ingelheim, novartis, UCB, Boehringer Ingelheim, Yolanda Braun-Moscovici: None declared, Elda Piovani: None declared, Claudia Barison: None declared, Liala Moschetti: None declared, Veronica Batani: None declared, Michal Tomcik: None declared, Francesca Motta: None declared, Maria De Santis: None declared, Petros P. Sfikakis AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Masataka Kuwana: None declared, Kamal Solanki: None declared, Brigitte Granel: None declared, Roberta Foti: None declared, Virginia Berlengiero: None declared, Joana Caetano: None declared, Yannick Allanore Abbvie, Alpine ImmunoSciences, Argenx, Astra-Zeneca, Boehringer Ingelheim, Corvus, Merck Serono, Topadur, Abbvie, Alpine ImmunoSciences, Argenx, Astra-Zeneca, Boehringer Ingelheim, Corvus, Merck Serono, Topadur, Marco Matucci-Cerinic: None declared, Franco Franceschini: None declared, Alexandra Balbir-Gurman: None declared, Paolo Airo': None declared. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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