ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Data from the SENSCIS-ON Trial
Session Title
TP24 - TP024 UNDERSTANDING AND TREATING AUTOIMMUNE LUNG DISEASE
Abstract
A1806 - Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Data from the SENSCIS-ON Trial
Author Block: K. B. Highland1, M. C. Vonk2, A. Azuma3, M. D. Mayes4, M. Gahlemann5, A. James6, V. Kohlbrenner7, Y. Allanore8, on behalf of the SENSCIS-ON trial investigators; 1Respiratory Institute/ Department of Pulmonary, Cleveland Clinic, Cleveland, OH, United States, 2Department of Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands, 3Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, 4Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, United States, 5Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland, 6Boehringer Ingelheim International GmbH, Ingelheim, Germany, 7Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States, 8Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.
Rationale: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of FVC decline (mL/year) over 52 weeks by 44% compared with placebo, with adverse events that were generally manageable. The safety and efficacy of nintedanib over the longer term are being assessed in the open-label extension trial SENSCIS-ON. Methods: Patients who completed the SENSCIS trial on trial drug were eligible to enter SENSCIS-ON. Female patients with SSc-ILD who completed a drug-drug interaction (DDI) study of nintedanib and oral contraceptive (ethinylestradiol and levonorgestrel), in which patients received nintedanib for ≤28 days, were eligible to enter SENSCIS-ON. We analyzed changes from baseline in FVC, adverse events, dose adjustments and permanent treatment discontinuations over 52 weeks in SENSCIS-ON in the “continued nintedanib” group (received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON), and in the “initiated nintedanib” group (received placebo in SENSCIS and initiated nintedanib in SENSCIS-ON or received nintedanib in the DDI study). Analyses were descriptive.Results: There were 197 patients in the “continued nintedanib” group and 247 patients (231 from SENSCIS) in the “initiated nintedanib” group. In these groups, respectively, mean (SD) FVC at baseline of SENSCIS-ON was 2379 (754) mL and 70.4 (18.1) % predicted and 2443 (814) mL and 70.8 (17.9) % predicted. Mean (SE) changes in FVC from baseline to week 52 of SENSCIS-ON were −58.3 (15.5) mL and −44.0 (16.2) mL in patients who continued and initiated nintedanib in SENSCIS-ON, respectively, similar to the change in FVC from baseline to week 52 in the nintedanib group of SENSCIS (−42.7 [14.2] mL). Based on proposed thresholds for minimal clinically important differences, from baseline to week 52 of SENSCIS-ON, 32.6% of patients had worsening of FVC. Diarrhea was reported in 68.0% and 68.8% of patients who continued and initiated nintedanib in SENSCIS-ON, respectively. For 99.3% and 95.3% in these groups, respectively, the worst diarrhea event was mild or moderate in intensity. Over 52 weeks, among patients who continued and initiated nintedanib, respectively, 18.3% and 49.4% had ≥1 dose reduction, 27.9% and 42.1% had ≥1 treatment interruption, 33% and 58.7% had ≥1 dose reduction and/or treatment interruption, and 10.2% and 23.9% permanently discontinued treatment.Conclusion: The change in FVC in patients who received nintedanib over 52 weeks in SENSCIS-ON was similar to that observed in the nintedanib group of SENSCIS. The safety profile of nintedanib over longer-term use was consistent with that seen over 52 weeks.
Author Block: K. B. Highland1, M. C. Vonk2, A. Azuma3, M. D. Mayes4, M. Gahlemann5, A. James6, V. Kohlbrenner7, Y. Allanore8, on behalf of the SENSCIS-ON trial investigators; 1Respiratory Institute/ Department of Pulmonary, Cleveland Clinic, Cleveland, OH, United States, 2Department of Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands, 3Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, 4Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, United States, 5Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland, 6Boehringer Ingelheim International GmbH, Ingelheim, Germany, 7Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States, 8Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.
Rationale: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of FVC decline (mL/year) over 52 weeks by 44% compared with placebo, with adverse events that were generally manageable. The safety and efficacy of nintedanib over the longer term are being assessed in the open-label extension trial SENSCIS-ON. Methods: Patients who completed the SENSCIS trial on trial drug were eligible to enter SENSCIS-ON. Female patients with SSc-ILD who completed a drug-drug interaction (DDI) study of nintedanib and oral contraceptive (ethinylestradiol and levonorgestrel), in which patients received nintedanib for ≤28 days, were eligible to enter SENSCIS-ON. We analyzed changes from baseline in FVC, adverse events, dose adjustments and permanent treatment discontinuations over 52 weeks in SENSCIS-ON in the “continued nintedanib” group (received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON), and in the “initiated nintedanib” group (received placebo in SENSCIS and initiated nintedanib in SENSCIS-ON or received nintedanib in the DDI study). Analyses were descriptive.Results: There were 197 patients in the “continued nintedanib” group and 247 patients (231 from SENSCIS) in the “initiated nintedanib” group. In these groups, respectively, mean (SD) FVC at baseline of SENSCIS-ON was 2379 (754) mL and 70.4 (18.1) % predicted and 2443 (814) mL and 70.8 (17.9) % predicted. Mean (SE) changes in FVC from baseline to week 52 of SENSCIS-ON were −58.3 (15.5) mL and −44.0 (16.2) mL in patients who continued and initiated nintedanib in SENSCIS-ON, respectively, similar to the change in FVC from baseline to week 52 in the nintedanib group of SENSCIS (−42.7 [14.2] mL). Based on proposed thresholds for minimal clinically important differences, from baseline to week 52 of SENSCIS-ON, 32.6% of patients had worsening of FVC. Diarrhea was reported in 68.0% and 68.8% of patients who continued and initiated nintedanib in SENSCIS-ON, respectively. For 99.3% and 95.3% in these groups, respectively, the worst diarrhea event was mild or moderate in intensity. Over 52 weeks, among patients who continued and initiated nintedanib, respectively, 18.3% and 49.4% had ≥1 dose reduction, 27.9% and 42.1% had ≥1 treatment interruption, 33% and 58.7% had ≥1 dose reduction and/or treatment interruption, and 10.2% and 23.9% permanently discontinued treatment.Conclusion: The change in FVC in patients who received nintedanib over 52 weeks in SENSCIS-ON was similar to that observed in the nintedanib group of SENSCIS. The safety profile of nintedanib over longer-term use was consistent with that seen over 52 weeks.
