POS0826 PREDICTORS OF RESPONSE AND LONG-TERM EFFICACY AND SAFETY OF NINTEDANIB IN SYSTEMIC SCLEROSIS-INTERSTITIAL LUNG DISEASE: DATA FROM AN ITALIAN MULTICENTRE STUDY
Authors: C. Campochiaro, G. De Luca, M. G. Lazzaroni, G. Armentaro, B. Ruaro, A. Stanziola, D. Benfaremo, E. De Lorenzis, B. Moccaldi, F. Bonomi, L. M. Bianchessi, F. Iannone, F. Cacciapaglia, A. Spinella, S. Guiducci, V. Codullo, S. L. Bosello, G. Cuomo, E. Zanatta, P. Confalonieri, N. Del Papa, P. Airo’, G. Moroncini, D. Giuggioli, L. Dagna, M. Matucci-Cerinic
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Nintedanib (NTD) has been shown to reduce the rate of decline in Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) following the positive results of the SENSCIS trial and sustained effects have been shown in the SENSCIS-ON study. <h3>Objectives:</h3> To analyse the predictors of response and NTD-related side effects at 1-year and efficacy and safety of NTD at 2-year in SSc-ILD in a real-life setting. <h3>Methods:</h3> The clinical data of SSc-ILD patients treated with NTD from 11 Italian SSc centres were retrospectively evaluated at 12 prior to NTD introduction; at baseline, and at 12 and 24 months after NTD introduction. The following parameters were recorded: SSc clinical features, concomitant therapies, NTD tolerability, pulmonary function tests (PFTs) and modified Rodnan skin score (mRSS). Progression was defined according to ATS definition (drop in predicted% FVC≥5% or DLCO≥10% or high-resolution chest tomography (HRCT) evolution and worsening of respiratory symptoms). Logistic regression analyses were performed to assess predictors of response at 1-year and predictors of NTD reduction/suspension. <h3>Results:</h3> 136 SSc-ILD patients treated with NTD were identified, disease features are summarized in Table 1. A progressive phenotype, 12 months prior to NTD introduction, was observed in 92 (67%) of patients. In those who achieved 1-year follow-up (84 (61%) patients), the percentage of 1-year progressors was significantly lower compared to the previous 12 months (64% versus 30%, p&lt;0.001). No significant change was observed for the mRSS at 12 months in dcSSc patients (7.5 ± 6.4 versus 6.1 ± 4.9, p=0.205). After a median time of 4 (2 – 8) months, NTD dose was reduced to 200 mg daily and maintained in 51 (37.5%) patients. In 19 (13.9%) patients, NTD was stopped after a median time of 3 (1-9) months. At logistic regression analysis only the presence of a diffuse cutaneous subset (OR 0.201 (0.001– 0.401)) was associated with 12-month progression-free response whereas the use of high-dose proton pump inhibitors (PPI) (OR 3.522 (1.057 – 11.0729)) was associated with NTD reduction/suspension. At 2 years, the percentage of progressors did not change compared to the first year (37%, p=0.465). The prevalence of NTD-related side-effects and causes of reduction and suspension are summarized in Figure 1. During the follow-up, 6 patients died after a median time of 10 (10 – 24) months. <h3>Conclusion:</h3> In a real-life clinical scenario, NTD, in combination with immunosuppressants, reduced the rate of progressors and this effect ins maintained at 2 years. A diffuse cutaneous subset seems a predictor of poorer response whereas the baseline use of high-dose PPI is a risk factor for poor drug tolerance. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> Corrado Campochiaro BI, BI, Jannsen, Novartis, Giacomo De Luca: None declared, Maria Grazia Lazzaroni: None declared, Giuseppe Armentaro: None declared, Barbara Ruaro: None declared, Anna Stanziola: None declared, Devis Benfaremo: None declared, Enrico De Lorenzis: None declared, Beatrice Moccaldi: None declared, Francesco Bonomi: None declared, Lorenzo Mattia Bianchessi: None declared, Florenzo Iannone: None declared, Fabio Cacciapaglia: None declared, Amelia Spinella: None declared, Serena Guiducci: None declared, Veronica Codullo: None declared, Silvia Laura Bosello: None declared, Giovanna Cuomo: None declared, Elisabetta Zanatta: None declared, Paola Confalonieri: None declared, Nicoletta Del Papa: None declared, Paolo Airo': None declared, Gianluca Moroncini: None declared, Dilia Giuggioli: None declared, Lorenzo Dagna: None declared, Marco Matucci-Cerinic: None declared.