AB0903 EFFICACY AND SAFETY OF NINTEDANIB IN COMBINATION WITH IMMUNOSUPPRESSIVE AGENTS FOR PROGRESSIVE FIBROSING CTD-ILD IN CLINICAL PRACTICE

Background Nintedanib (NTB), a multitargeted tyrosine kinase inhibitor, has been approved in Japan for progressive fibrosing interstitial lung disease (PF-ILD) since May 2020 based on the results of INBUILD trial [1]. This also made it new treatment option connective tissue (CTD) that are frequently complicated by ILD. On other hand, use immunosuppressive agents ILD and primary diseases varies type country. Objectives The purpose this study is to evaluate efficacy safety NTB CTD-ILD treated with at single center Japan. Methods patients who received our institution between 2022 were extracted. Among NTB, those met criteria PF-ILD (1) included analysis. Efficacy was evaluated changes forced vital capacity (FVC), monthly rate decline FVC (ΔFVC %/M) before after initiation NTB. Changes KL-6 (Krebs von den Lungen 6), serum biomarker ILD, analyzed. In addition, these parameters compared two groups; one group additional same time as administration (NTB+IS group), only (NTB group). Safety occurrence adverse events within 12 months. Results There 24 (8 males 16 females) all whom PF-ILD. Patient characteristics shown Table 1. most common systemic sclerosis 8 (33.3%), followed polymyositis/dermatomyositis 6 (25.0%). mean 56.8±15.1 % 1600.0±600.1 mL. Mean increased months %: +6.4 %/6M; +8.1 %/12M) ΔFVC %/M improved from -0.65 +1.06 Serum decreased significantly (ΔKL-6 U/mL: -233.7 U/mL/6M; -401.4 U/mL/12M). Eleven administrated concurrently rituximab 5 patients, glucocorticoids (>20 mg/day prednisone or equivalent) 4, cyclophosphamide 2, abatacept mycophenolate mofetil + IS group, 13 group) (+1.81%/M vs. +0.20%/M, respectively) (Figure 1). Adverse (AEs) considered be related diarrhea nausea 2 elevations liver enzymes headache 1 patient, dose reduced 11 patients. No patient discontinued due AEs. Conclusion appeared effective safe clinical practice. suggested combination may an strategy. Because small, single-center, observational study, further research needed clarify timing used combination. Reference [1]Flaherty KR, et al. N Engl J Med. 2019;381:1718-1827. (n =24). Age, mean±SD, years 65.3±10.7 Sex, Female, number (%) (66.7) Disease duration, 8.5±7.7 Primary Systemic sclerosis, n (33.3) Polymyositis, Dermatomyositis, (25.0) Rheumatoid arthritis, 4 (16.7) Microscopic polyangiitis, 3 (12.5) Others, KL-6, U/mL 1479.0±967.9 predicted value, mL, mL Concomitant Glucocorticoids，number 19 (79.1) Tacrolimus, 7 (29.2) Mycophenolate mofetil, (20.8) Rituximab, Azathioprine, Abatacept, (8.3) Cyclophosphamide, (4.2) Figure Acknowledgements: NIL. Disclosure Interests None Declared.