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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Impact of Mepolizumab on Disease Flares in Patients with Hypereosinophilic Syndrome
Session Title
TP24 - TP024 UNDERSTANDING AND TREATING AUTOIMMUNE LUNG DISEASE
Abstract
A1809 - Impact of Mepolizumab on Disease Flares in Patients with Hypereosinophilic Syndrome
Author Block: F. Pane1, G. Lefevre2, N. Kwon3, J. H. Bentley4, S. W. Yancey5, J. Steinfeld6; 1Division of Hematology, Department of Clinical Medicine and Surgery, 'Federico II' University, Naples, Italy, 2Université de Lille, CHU Lille, Institut d’Immunologie, Centre de Référence National des Syndromes Hyperéosinophiliques (CEREO), Institute for Translational Research in Inflammation Infinite-U1286, Inserm, Lille, France, 3Respiratory Research & Development, GSK, Brentford, London, United Kingdom, 4Clinical Statistics, GSK, Brentford, London, United Kingdom, 5Respiratory Therapeutic Area Unit, GSK, Research Triangle Park, NC, United States, 6Respiratory Research & Development, GSK, Collegeville, PA, United States.
Rationale: Treatment with mepolizumab, a humanized anti-interleukin-5 monoclonal antibody, is associated with a reduction in disease flares in patients with hypereosinophilic syndrome (HES). Here, we characterized flare symptoms and assessed the impact of mepolizumab on flare duration.
Methods: This placebo-controlled, double-blind, parallel-group, Phase III trial enrolled patients ≥12 years old with HES for ≥6 months, ≥2 flares in the previous 12 months, and a blood eosinophil count ≥1000 cells/μL at screening. Patients maintained ≥4 weeks stable HES therapy before randomization (1:1) to 4-weekly subcutaneous mepolizumab (300 mg) or placebo, plus baseline HES therapy, for 32 weeks. For these analyses, only type A flares were included; defined as an increase of ≥10 mg/day oral corticosteroid or an addition/increase in cytotoxic/immunosuppressive HES therapy in response to a change in clinical symptoms. The start date of a flare was the date of therapy escalation; flares <14 days apart were classed as one event. Verbatim flare narratives recorded by the investigator were categorized post hoc into seven symptom categories (constitutional, dermatological, gastrointestinal, respiratory, nasal, neurological, other) and summarized; data on flare duration were also assessed.
Results: Throughout the study, 15 flares were reported in 12/54 patients receiving mepolizumab; 35 flares were reported in 23/54 patients receiving placebo. Overall, the most reported flare symptoms were constitutional (94%, n=47/50), skin (82%, n=41/50), and respiratory (72%, n=36/50). Of the constitutional symptoms, fatigue (n=43/47) and pain (n=37/47) ranked highest. Constitutional symptoms were the most frequently reported symptoms for flares occurring in both treatment groups (mepolizumab: 100%, n=15/15; placebo: 91%, n=32/35). For flares occurring in patients receiving mepolizumab, nasal and respiratory flare symptoms were reported more frequently than for flares occurring in patients receiving placebo (87%, n=13/15 and 80%, n=12/15 vs 60%, n=21/35 and 69%, n=24/35, respectively). Skin and neurological flare symptoms were more common for flares occurring in patients receiving placebo (86%, n=30/35 and 60% n=21/35) than for flares occurring in patients receiving mepolizumab (73%, n=11/15 and 40%, n=6/15). Mepolizumab treatment was also associated with reduced total flare duration versus placebo (median [range] days: 10.0 [4-126] vs 26.0 [1-154]) (Figure).
Conclusions: In patients with HES, flares were associated with symptoms linked to multiple organ systems, including skin and respiratory. For the small number of flares recorded for patients receiving mepolizumab, there were some differences in the organ systems affected, and the quantity and duration of flares was at least halved compared with placebo.
Funding: GSK(200622/NCT02836496)
Author Block: F. Pane1, G. Lefevre2, N. Kwon3, J. H. Bentley4, S. W. Yancey5, J. Steinfeld6; 1Division of Hematology, Department of Clinical Medicine and Surgery, 'Federico II' University, Naples, Italy, 2Université de Lille, CHU Lille, Institut d’Immunologie, Centre de Référence National des Syndromes Hyperéosinophiliques (CEREO), Institute for Translational Research in Inflammation Infinite-U1286, Inserm, Lille, France, 3Respiratory Research & Development, GSK, Brentford, London, United Kingdom, 4Clinical Statistics, GSK, Brentford, London, United Kingdom, 5Respiratory Therapeutic Area Unit, GSK, Research Triangle Park, NC, United States, 6Respiratory Research & Development, GSK, Collegeville, PA, United States.
Rationale: Treatment with mepolizumab, a humanized anti-interleukin-5 monoclonal antibody, is associated with a reduction in disease flares in patients with hypereosinophilic syndrome (HES). Here, we characterized flare symptoms and assessed the impact of mepolizumab on flare duration.
Methods: This placebo-controlled, double-blind, parallel-group, Phase III trial enrolled patients ≥12 years old with HES for ≥6 months, ≥2 flares in the previous 12 months, and a blood eosinophil count ≥1000 cells/μL at screening. Patients maintained ≥4 weeks stable HES therapy before randomization (1:1) to 4-weekly subcutaneous mepolizumab (300 mg) or placebo, plus baseline HES therapy, for 32 weeks. For these analyses, only type A flares were included; defined as an increase of ≥10 mg/day oral corticosteroid or an addition/increase in cytotoxic/immunosuppressive HES therapy in response to a change in clinical symptoms. The start date of a flare was the date of therapy escalation; flares <14 days apart were classed as one event. Verbatim flare narratives recorded by the investigator were categorized post hoc into seven symptom categories (constitutional, dermatological, gastrointestinal, respiratory, nasal, neurological, other) and summarized; data on flare duration were also assessed.
Results: Throughout the study, 15 flares were reported in 12/54 patients receiving mepolizumab; 35 flares were reported in 23/54 patients receiving placebo. Overall, the most reported flare symptoms were constitutional (94%, n=47/50), skin (82%, n=41/50), and respiratory (72%, n=36/50). Of the constitutional symptoms, fatigue (n=43/47) and pain (n=37/47) ranked highest. Constitutional symptoms were the most frequently reported symptoms for flares occurring in both treatment groups (mepolizumab: 100%, n=15/15; placebo: 91%, n=32/35). For flares occurring in patients receiving mepolizumab, nasal and respiratory flare symptoms were reported more frequently than for flares occurring in patients receiving placebo (87%, n=13/15 and 80%, n=12/15 vs 60%, n=21/35 and 69%, n=24/35, respectively). Skin and neurological flare symptoms were more common for flares occurring in patients receiving placebo (86%, n=30/35 and 60% n=21/35) than for flares occurring in patients receiving mepolizumab (73%, n=11/15 and 40%, n=6/15). Mepolizumab treatment was also associated with reduced total flare duration versus placebo (median [range] days: 10.0 [4-126] vs 26.0 [1-154]) (Figure).
Conclusions: In patients with HES, flares were associated with symptoms linked to multiple organ systems, including skin and respiratory. For the small number of flares recorded for patients receiving mepolizumab, there were some differences in the organ systems affected, and the quantity and duration of flares was at least halved compared with placebo.
Funding: GSK(200622/NCT02836496)
