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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Preservation of Lung Function with Tocilizumab in Patients with Systemic Sclerosis Interstitial Lung Disease: Analysis from the Double-Blind Period of a Phase 3 Trial
Session Title
TP24 - TP024 UNDERSTANDING AND TREATING AUTOIMMUNE LUNG DISEASE
Abstract
A1808 - Preservation of Lung Function with Tocilizumab in Patients with Systemic Sclerosis Interstitial Lung Disease: Analysis from the Double-Blind Period of a Phase 3 Trial
Author Block: D. Khanna1, C. J. F. Lin2, D. E. Furst3, M. Zucchetto4, G. Raghu5, F. J. Martinez6, C. P. Denton7; 1University of Michigan, Ann Arbor, MI, United States, 2Genentech, South San Francisco, CA, United States, 3University of California, Los Angeles, Los Angeles, CA, United States, 4Parexel International, Milan, Italy, 5University of Washington, Seattle, WA, United States, 6Weill Cornell Medical College, New York, NY, United States, 7University College London, London, United Kingdom.
Rationale. Tocilizumab, an anti-interleukin-6 receptor antibody, may preserve or improve lung function in the subset of patients with systemic sclerosis (SSc) who have SSc-associated interstitial lung disease (SSc-ILD). Here we present post hoc data from the multicenter, randomized, double-blind, placebo-controlled, phase 3 focuSSced study in patients with SSc-ILD at baseline. Methods. Adult patients with SSc for ≤60 months, modified Rodnan skin score 10-35 units at screening, and elevated acute-phase reactant levels at baseline were randomly assigned 1:1 to receive weekly subcutaneous injections of tocilizumab 162 mg or placebo for 48 weeks. Patients included in this analysis had SSc-ILD at baseline, as assessed by high-resolution computed tomography. Lung function was assessed by change from baseline to week 48 in absolute forced vital capacity (FVC) and percent-predicted forced vital capacity (ppFVC). Results. In total, 136 patients with SSc-ILD at baseline were included in this analysis (placebo, 68; tocilizumab, 68). Roughly one-half of patients receiving weekly tocilizumab (29/59, 49.2%) did not experience any decrease in ppFVC from baseline to week 48 compared with one-quarter of patients receiving placebo (14/56, 25.0%); the same was observed for percentage change in absolute FVC (Figure). In addition, patients in the tocilizumab group were less likely than those in the placebo group to experience a decrease of ≥10% ppFVC (8.5% vs 25.0%, respectively) and more likely to experience an increase of ≥10% ppFVC (10.2% vs 1.8%, respectively). In the placebo group, 10.7% of patients experienced a severe decrease in absolute FVC (FVC decrease, 25%-35%) compared with 0 patients in the tocilizumab group, whereas more patients treated with tocilizumab than placebo experienced an FVC increase of ≥5% compared with baseline (25.4% vs 5.4%) (Figure). Conclusions. Results from this 48-week study suggest that early identification of ILD and initiation of tocilizumab treatment may help preserve lung function in patients with SSc-ILD and elevated inflammatory markers. In addition, tocilizumab may help restore lung function in some patients.
Author Block: D. Khanna1, C. J. F. Lin2, D. E. Furst3, M. Zucchetto4, G. Raghu5, F. J. Martinez6, C. P. Denton7; 1University of Michigan, Ann Arbor, MI, United States, 2Genentech, South San Francisco, CA, United States, 3University of California, Los Angeles, Los Angeles, CA, United States, 4Parexel International, Milan, Italy, 5University of Washington, Seattle, WA, United States, 6Weill Cornell Medical College, New York, NY, United States, 7University College London, London, United Kingdom.
Rationale. Tocilizumab, an anti-interleukin-6 receptor antibody, may preserve or improve lung function in the subset of patients with systemic sclerosis (SSc) who have SSc-associated interstitial lung disease (SSc-ILD). Here we present post hoc data from the multicenter, randomized, double-blind, placebo-controlled, phase 3 focuSSced study in patients with SSc-ILD at baseline. Methods. Adult patients with SSc for ≤60 months, modified Rodnan skin score 10-35 units at screening, and elevated acute-phase reactant levels at baseline were randomly assigned 1:1 to receive weekly subcutaneous injections of tocilizumab 162 mg or placebo for 48 weeks. Patients included in this analysis had SSc-ILD at baseline, as assessed by high-resolution computed tomography. Lung function was assessed by change from baseline to week 48 in absolute forced vital capacity (FVC) and percent-predicted forced vital capacity (ppFVC). Results. In total, 136 patients with SSc-ILD at baseline were included in this analysis (placebo, 68; tocilizumab, 68). Roughly one-half of patients receiving weekly tocilizumab (29/59, 49.2%) did not experience any decrease in ppFVC from baseline to week 48 compared with one-quarter of patients receiving placebo (14/56, 25.0%); the same was observed for percentage change in absolute FVC (Figure). In addition, patients in the tocilizumab group were less likely than those in the placebo group to experience a decrease of ≥10% ppFVC (8.5% vs 25.0%, respectively) and more likely to experience an increase of ≥10% ppFVC (10.2% vs 1.8%, respectively). In the placebo group, 10.7% of patients experienced a severe decrease in absolute FVC (FVC decrease, 25%-35%) compared with 0 patients in the tocilizumab group, whereas more patients treated with tocilizumab than placebo experienced an FVC increase of ≥5% compared with baseline (25.4% vs 5.4%) (Figure). Conclusions. Results from this 48-week study suggest that early identification of ILD and initiation of tocilizumab treatment may help preserve lung function in patients with SSc-ILD and elevated inflammatory markers. In addition, tocilizumab may help restore lung function in some patients.
