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• W4387248876 abstract "SESSION TITLE: Pulmonary Manifestations of Systemic Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2023 12:00 pm - 12:45 pm PURPOSE: Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis (SSc) and the leading cause of death in patients with SSc. In the placebo-controlled trials in patients with a progressive phenotype SSc-ILD, Nintedanib reduced the rate of decline in forced vital capacity. The adverse events (AE) profile of Nintedanib in patients with ILD is characterized mainly by gastrointestinal AE. Gastrointestinal tract is also a common manifestation associated with SSc and with standard therapy used for SSc. The purpose of our study was to evaluate the safety and tolerability of Nintedanib in Russian patients with progressive SSс-ILD phenotype. METHODS: 20 patients (the average age 52.7±11.9 years, females 90%, SSc duration 10±6.3 years, diffused:limited form ratio - 1:3.5) with the confirmed SSc diagnosis and signs of progressive ILD were enrolled into the study. All patients received low- and moderate-dose of prednisolone regimens. Nintedanib was added to immunosuppressants (Mycophenolate mofetil, Azathioprine, Cyclophosphamide) due to inadequate efficacy of the previous therapy. 13 patients received Nintedanib (300 mg per day) over the follow-up period. 13 patients who had received therapy with Nantedanib for at least 6 months (9,7±6,2) were included in the follow-up analysis. RESULTS: The percentages of patients with any AE was 92.3. More than 1 AE was observed in 8 (61.5%) patients. 5 (38.5%) patients developed diarrhea, which required temporary withdrawal of the drug or dose reduction to 150 mg/day. In one case (7.7%) severe diarrhea led to the discontinuation of the drug. 5 (38.5%) patients had moderate nausea (3 pts) and vomiting (2 pts). Laboratory disorders were detected in 4 (30.1%) patients: increased levels of AST – 3 pts, ALT – 4 pts, GAMMA-GTP-3 pts, alkaline phosphatase-1 pt. No patient had an overshoot of liver enzymes more than three times from the upper limit of the normal. In one case (7.7%), there were no AE during Nintedanib therapy. The percentage of patients who had a mild and short-term adverse event was 30.8 (diarrhea at the beginning of admission – 2 pts, diarrhea and nausea at the beginning of admission -1 pt, nausea when increasing the dose to 300 mg/day - 1 pt). The formation of digital necrosis was noted in 3 patients. CONCLUSIONS: During therapy with Nintedanib, AE from the gastrointestinal tract were the most frequent in patients with SSc-ILD, were observed in 92% of patients, but only in 1 case caused the withdrawal of the drug; Mild laboratory disorders, namely an increase in liver enzymes, were detected in a third of patients; The formation of digital necrosis on the background of therapy was observed in 3 cases, but all patients had progression of vascular disorders already at the time of inclusion in the study. CLINICAL IMPLICATIONS: The AE profile of Nintedanib in patients with ILD is characterized mainly by gastrointestinal AE. Laboratory disorders were rare and mild. DISCLOSURES: No relevant relationships by Lidia Ananyeva No relevant relationships by Oxana Desinova No relevant relationships by Liudmila Garzanova No relevant relationships by Olga Koneva No relevant relationships by Olga Ovsyannikova No relevant relationships by Mayya Starovoytova" @default.
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• W4387248876 date "2023-10-01" @default.
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• W4387248876 title "THE STUDY OF THE NINTEDANIB SAFETY PROFILE IN PATIENTS WITH SYSTEMIC SCLEROSIS ASSOCIATED WITH INTERSTITIAL LUNG DISEASE" @default.
• W4387248876 doi "https://doi.org/10.1016/j.chest.2023.07.3552" @default.
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