Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Cohort Enrichment Strategies for Progressive Interstitial Lung Disease in Systemic Sclerosis From European Scleroderma Trials and Research
Chest, Volume 163, No. 3, Year 2023
Notification
URL copied to clipboard!
Description
Background: Enrichment strategies from clinical trials for progressive systemic sclerosis-associated interstitial lung disease (SSc-ILD) have not been tested in a real-life cohort. Research Question: Do enrichment strategies for progressive ILD impact efficacy, representativeness, and feasibility in patients with SSc-ILD from the European Scleroderma Trials and Research (EUSTAR) database? Study Design and Methods: We applied the inclusion criteria of major recent SSc-ILD trials (Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis [focuSSced], Scleroderma Lung Study II [SLS II], and Safety and Efficacy of Nintedanib in Systemic Sclerosis [SENSCIS]) and assessed progressive ILD, which was defined as absolute change in FVC and as significant progression (FVC decline ≥10%). Data were compared with all patients and with patients who did not fulfill any inclusion criteria. Results: In total, 2,258 patients with SSc-ILD were included: 31.2% of the patients met SENSCIS criteria; 5.8% of the patients met SLS II criteria; 1.6% of the patients met focuSSced criteria, and 67.7% (1,529) of the patients did not meet any criteria. In the first 12 ± 3 months, the absolute FVC decline in all patients and in patients who fulfilled criteria from SENSCIS was –0.1%, in patients who fulfilled criteria from focuSSced was –3.7%, and in patients who fulfilled criteria from SLS II was 2.3%, with accompanying more progressors in focuSSced. The patient populations that fulfilled the different study inclusion criteria significantly differed in various clinical parameters. In the second 12-month period, SENSCIS-enriched patients had a further absolute FVC% decline as described for the total cohort. In contrast, patients who fulfilled the focuSSced and SLS II criteria showed numeric improvement of lung function. There were no significant associations of enrichment criteria and ILD progression. Interpretation: The application of enrichment criteria from previous clinical trials showed enrichment for progression with variable success, which led to selected patient populations reducing feasibility of recruitment. These findings are important for future clinical trial design and interpretation of the results of published trials. © 2022 American College of Chest Physicians
Authors & Co-Authors
Hoffmann-Vold, Anna Maria
Norway, Oslo
Oslo Universitetssykehus
Switzerland, Zurich
Universität Zürich
Airo’, Paolo
Italy, Brescia
Spedali Civili Di Brescia
Czirjak, László
Hungary, Pecs
University of Pécs Medical School
Guiducci, Serena
Italy, Florence
Azienda Ospedaliera Careggi
Hachulla, Éric
France, Lille
Chu Lille
Li, Mengtao
China, Beijing
Peking Union Medical College Hospital
Mihai, Carina Marina
Switzerland, Zurich
Universität Zürich
Riemekasten, Gabriela
Germany, Kiel
Universitätsklinikum Schleswig-holstein Campus Kiel
SFIKAKIS, P. Paul
Greece, Athens
National and Kapodistrian University of Athens
Valentini, Gabriele
Italy, Naples
Università Degli Studi Della Campania Luigi Vanvitelli
Kowal-Bielecka, Otylia M.
Poland, Bialystok
Uniwersytet Medyczny w Bialymstoku
Allanore, Yannick
France, Paris
Ap-hp Assistance Publique - Hopitaux de Paris
Distler, Oliver
Switzerland, Zurich
Universität Zürich
Vacca, Alessandra
Unknown Affiliation
Giollo, Alessandro
Unknown Affiliation
Balbir-Gurman, Alexandra
Unknown Affiliation
Marcoccia, Antonella
Unknown Affiliation
Herrick, Ariane Loraine
Unknown Affiliation
Radič, Mislav
Unknown Affiliation
Stamenković, Bojana N. N.
Unknown Affiliation
Anić, Branimir B.
Unknown Affiliation
Granel, Brigitte
Unknown Affiliation
Ribi, Camillo
Unknown Affiliation
Selmi, Carlo Francesco
Unknown Affiliation
de Souza Müller, Carolina
Unknown Affiliation
Denton, Christopher Paul
Unknown Affiliation
Kayser, Cristiane
Unknown Affiliation
Tǎnǎseanu, Cristina Mihaela
Unknown Affiliation
Rimar, Doron
Unknown Affiliation
Krasowska, Dorota Maria
Unknown Affiliation
Veale, Douglas James
Unknown Affiliation
Walker, Ulrich Andreas
Unknown Affiliation
Kerzberg, Eduardo Mario
Unknown Affiliation
Rezuş, Elena
Unknown Affiliation
Zanatta, Elisabetta
Unknown Affiliation
Siegert, Elise
Unknown Affiliation
de Langhe, Ellen
Unknown Affiliation
Ingegnoli, Francesca
Unknown Affiliation
Cantatore, Francesco Paolo
Unknown Affiliation
Szűcs, Gabriella
Unknown Affiliation
Cuomo, Giovanna
Unknown Affiliation
Morović-Vergles, Jadranka
Unknown Affiliation
Sibilia, Jean
Unknown Affiliation
Henes, Jörg Christoph
Unknown Affiliation
Solanki, Kamal Kishor
Unknown Affiliation
Saketkoo, Lesley Ann
Unknown Affiliation
Stamp, Lisa K.
Unknown Affiliation
Mouthon, Luc
Unknown Affiliation
Salvador, Maria João
Unknown Affiliation
Pozzi, Maria Rosa
Unknown Affiliation
Üprus, Maria
Unknown Affiliation
Vanthuyne, Marie
Unknown Affiliation
Engelhart, Merete
Unknown Affiliation
Köhm, Michaela
Unknown Affiliation
Iudici, Michele
Unknown Affiliation
Inanç, Murat
Unknown Affiliation
Fathi, Nihal Ahmad
Unknown Affiliation
Carreira-Delgado, Patricia E.
Unknown Affiliation
Bancel, Dominique Farge
Unknown Affiliation
Montecucco, Carlomaurizio
Unknown Affiliation
Ancuța, Codrina Michaela
Unknown Affiliation
Sunderkoẗter, Cord H.
Unknown Affiliation
Müller-Ladner, Ulf
Unknown Affiliation
Rosato, Edoardo
Unknown Affiliation
Kucharz, Eugene J.
Unknown Affiliation
Iannone, Florenzo
Unknown Affiliation
Kötter, Ina
Unknown Affiliation
Distler, Jor̈g H.W.
Unknown Affiliation
Cutolo, Maurizio
Unknown Affiliation
Tikly, Mohammed
Unknown Affiliation
Damjanov, Nemanja S.
Unknown Affiliation
Hunzelmann, Nicolas
Unknown Affiliation
Vlachoyiannopoulos, Panayiotis G.
Unknown Affiliation
Hasler, Paul
Unknown Affiliation
Sarzi-Puttini, Piercarlo
Unknown Affiliation
Wiland, Piotr
Unknown Affiliation
Bečvář, Radim
Unknown Affiliation
Yavuz, Şule Kurhan
Unknown Affiliation
Pellerito, Raffaele A.
Unknown Affiliation
Foti, Rosario
Unknown Affiliation
Ionescu, Ruxandra Maria
Unknown Affiliation
Adler, Sabine
Unknown Affiliation
Kahl, Sarah
Unknown Affiliation
Moiseev, Sergey V.
Unknown Affiliation
Stebbings, Simon M.
Unknown Affiliation
Rednic, S.
Unknown Affiliation
Heitmann, Stefan
Unknown Affiliation
Ullman, Susanne
Unknown Affiliation
Schmeiser, Tim
Unknown Affiliation
Riccieri, Valeria
Unknown Affiliation
Smith, Vanessa
Unknown Affiliation
Ortiz-Santamaría, Vera
Unknown Affiliation
Abdel Atty Mohamed, Walid Ahmed
Unknown Affiliation
Statistics
Citations: 4
Authors: 93
Affiliations: 13
Identifiers
Doi:
10.1016/j.chest.2022.09.044
ISSN:
00123692
Research Areas
Health System And Policy
Study Design
Cohort Study