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RISS 인기검색어
- 검색키워드
- 저자 : ( Susanne Stowasser ) (검색결과 4 건)
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P-137 Long-Term Nintedanib Treatment in Idiopathic Pulmonary Fibrosis
( Jin Woo Song ),( Bruno Crestani ),( Manuel Quaresma ),( Mitchell Kaye ),( Wibke Stansen ),( Susanne Stowasser ),( Micheael Kreuter ) 대한결핵 및 호흡기학회 2017 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.124 No.-
Background: The efficacy and safety of nintedanib 150 mg twice daily in patients with IPF were assessed in the two Phase III INPULSIS trials. Patients who completed the 52-week treatment period and follow-up visit 4 weeks later in INPULSIS could receive open-label nintedanib in the extension trial INPULSIS-ON. Aim: To assess the long-term efficacy and safety of nintedanib based on an interim analysis of INPULSIS-ON Methods: Patients treated with placebo in INPULSIS initiated nintedanib in INPULSIS-ON; patients treated with nintedanib continued nintedanib. Results: 734 patients were treated in INPULSIS-ON (430 continuing nintedanib; 304 initiating nintedanib). At baseline of INPULSIS-ON, mean age was 67.2 years; 80.0% of patients were male, 58.7% were White, 29.3% were Asian. Mean FVC was 76.2% predicted. At this interim analysis, mean (SD) exposure in INPULSIS-ON was 27.7 (15.1) months. Mean (SD; minimum- maximum) total exposure for patients treated with nintedanib in INPULSIS and INPULSIS-ON was 40.7 (14.6; 11.9-63.1) months. In all patients treated in INPULSIS-ON, mean (SD) change in FVC from baseline of INPULSIS-ON to week 144 of INPULSIS-ON was -305 (365) mL; the annual rate (SE) of decline in FVC over 144 weeks was -131 (6) mL/year. The adverse event profile of nintedanib in INPULSIS-ON was consistent with that in INPULSIS. Conclusions: Data from INPULSIS-ON indicated that the effect of nintedanib on reducing disease progression is maintained over the long term. Nintedanib treatment (up to 63 months) had an acceptable safety and tolerability prof
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( Jin Woo Song ),( Kevin K Brown ),( Simon Lf Walsh ),( Anand Devaraj ),( Wim A Wuyts ),( Claudia Valenzuela ),( Rainer-georg Goeldner ),( Susanne Stowasser ),( Rozsa Schlenker-herceg ),( Athol U Well 대한결핵 및 호흡기학회 2020 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.128 No.-
Background Several studies have suggested that the progression of fibrosing ILDs is more rapid in patients with a usual interstitial pneumonia (UIP) pattern on HRCT. In the INBUILD trial, nintedanib slowed the rate of decline in FVC in subjects with fibrosing ILDs and a progressive phenotype. We assessed the effect of nintedanib in subgroups by HRCT pattern at baseline. Methods In the INBUILD trial, subjects (n=663) with a progressive fibrosing ILD were randomized to receive nintedanib or placebo. Randomization was stratified by HRCT pattern (UIP-like fibrotic pattern or other fibrotic patterns) based on central review. In pre-specified analyses, we assessed the effects of nintedanib in subgroups of subjects with a UIP-like fibrotic pattern and other fibrotic patterns on HRCT at baseline. Results At baseline, 62.1% of total subjects had a UIP-like fibrotic pattern on HRCT. In subjects who received placebo, the adjusted mean annual rate (SE) of decline in FVC was -209.2 (19.1) mL/year in subjects with a UIP-like fibrotic pattern on HRCT and -155.4 (23.6) mL/year in subjects with other fibrotic patterns on HRCT. The difference between the nintedanib and placebo groups in the annual rate of decline in FVC was 127.8 (95% CI: 74.3, 181.2) mL/year in subjects with a UIP-like fibrotic pattern on HRCT and 75.4 (95% CI: 9.5, 141.4) mL/year in subjects with other fibrotic patterns on HRCT (treatment-by-subgroup-by-time interaction p=0.23) (Table). The effects of nintedanib vs placebo on change from baseline in K-BILD questionnaire total score at week 52, time to acute exacerbation of ILD or death over 52 weeks, and time to death over 52 weeks between the subgroups by HRCT pattern are shown in the Table. Conclusions In the INBUILD trial, the effect of nintedanib on slowing the rate of FVC decline was consistent regardless of fibrotic pattern on HRCT.
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( Jin Woo Song ),( Kevin R Flaherty ),( Athol U Wells ),( Vincent Cottin ),( Anand Devaraj ),( Yoshikazu Inoue ),( Luca Richeldi ),( Simon Walsh ),( Susanne Stowasser ),( Carl Coeck ),( Rainer-georg G 대한결핵 및 호흡기학회 2019 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.127 No.-
Background: Nintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF). Pre-clinical data suggest that nintedanib inhibits processes fundamental to progression of lung fibrosis irrespective of the aetiology. The INBUILD trial was designed to investigate the efficacy and safety of nintedanib in patients with various non-IPF chronic fibrosing ILDs with progressive phenotype. Methods: Eligible patients had diffuse fibrosing lung disease of >10% extent on HRCT, FVC ≥45% predicted, DLCO ≥30-<80% predicted, and met ≥1 of 4 criteria for ILD progression (Table) in the 24 months before screening, despite treatment of ILDs in clinical practice. Patients with IPF were excluded. Subjects were randomised to receive nintedanib 150 mg bid or placebo. The primary endpoint is the annual rate of decline in FVC (mL/yr) assessed over 52 weeks. There will be two co-primary analysis populations: all subjects and subjects with a UIP-like fibrotic pattern only on HRCT. Results: 663 patients were randomised and treated (Table). Mean (±SD) age was 65.8±9.8 years, FVC was 69.0±15.7% predicted, DLco was 47.6±32.2% predicted. Conclusions: The INBUILD trial will provide insights into the natural history and role of nintedanib in treating patients with various progressive fibrosing ILDs. Results will be presented at the congress.
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Long-term nintedanib treatment in idiopathic pulmonary fibrosis (IPF) : final data from INPULSIS-ON
( Jin Woo Song ),( Bruno Crestani ),( Manuel Quaresma ),( Mitchell Kaye ),( Takashi Ogura ),( Wibke Stansen ),( Susanne Stowasser ),( Michael Kreuter ) 대한결핵 및 호흡기학회 2018 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.126 No.-
Background & Aims: The two 52-week Phase III INPULSIS trials investigated the efficacy and safety of nintedanib 150 mg bid vs placebo in patients with IPF. Patients who completed an INPULSIS trial could receive open-label nintedanib in the extension trial INPULSIS-ON. We assessed the long-term efficacy and safety of nintedanib based on final data from INPULSIS-ON. Methods: Placebo-treated patients in INPULSIS initiated nintedanib in INPULSIS-ON; patients treated with nintedanib in INPULSIS continued nintedanib in INPULSIS-ON. Results: 734 patients were treated in INPULSIS-ON (430 continuing nintedanib; 304 initiating nintedanib). Mean (SD) exposure in INPULSIS-ON was 29.0 (16.4) months; total exposure to nintedanib in both INPULSIS and INPULSIS-ON was 42.1 (16.0) months (max: 68.3 months). In INPULSIS, mean (SD) changes from baseline in FVC at week 52 were -89 (264) mL with nintedanib vs -203 (293) mL with placebo; annual rates (SE) of decline in FVC were -114 (11) mL/year and -224 (13) mL/year in these groups. In INPULSIS-ON, mean (SD) change from baseline in FVC at week 192 was -327 (385) mL; the annual rate (SE) of decline in FVC over 192 weeks was -135 (6) mL/year. The adverse event profile of nintedanib in INPULSIS-ON was consistent with that observed in INPULSIS. Conclusions: Final data from INPULSIS-ON indicate that the effect of nintedanib on reducing disease progression in patients with IPF is maintained over the long term. Nintedanib treatment, up to 68 months, had an acceptable safety and tolerability profile.
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