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Baseline clinical characteristics, comorbidities and prescribed medication in a real-world population of patients with idiopathic pulmonary fibrosis: the PROOF registry
  1. Wim A Wuyts1,
  2. Caroline Dahlqvist2,
  3. Hans Slabbynck3,
  4. Marc Schlesser4,
  5. Natacha Gusbin5,
  6. Christophe Compere6,
  7. Sofie Maddens7,
  8. Klaus-Uwe Kirchgaessler8,
  9. Karen Bartley9 and
  10. Benjamin Bondue10
  1. 1 Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium
  2. 2 CHU UCL Dinant Godinne, Yvoir, Belgium
  3. 3 Department of Respiratory Medicine, ZNA Middelheim, Antwerp, Belgium
  4. 4 Department of Respiratory Medicine, Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg
  5. 5 CHR de la Citadelle, Liège, Belgium
  6. 6 CHIREC Hospital, Brussels, Belgium
  7. 7 AZ Groeninge, Kortrijk, Belgium
  8. 8 F. Hoffmann-La Roche, Ltd.,, Basel, Switzerland
  9. 9 Genentech, Inc., South San Francisco, California, USA
  10. 10 Department of Respiratory Medicine, Erasme University Hospital, Brussels, Belgium
  1. Correspondence to Professor Wim A Wuyts; wim.wuyts{at}uzleuven.be

Abstract

Introduction PROOF (a Prospective Observational Registry to Describe the Disease Course and Outcomes of Idiopathic Pulmonary Fibrosis) is an ongoing, observational registry initiated in 2013 with the aim of collecting real-world data from patients with idiopathic pulmonary fibrosis (IPF). Here, we present comprehensive baseline data, which were collected from patients on registry inclusion.

Methods Patients with IPF were enrolled across eight centres in Belgium and Luxembourg. Baseline data collected included demographics, diagnostic information and clinical characteristics, including lung function and health-related quality of life. Data on comorbidities and prescribed medication were also collected.

Results A total of 277 patients were enrolled in the PROOF registry. At inclusion, 92.8% and 6.5% of patients had a definite or probable diagnosis of IPF, respectively. Mean per cent predicted forced vital capacity and carbon monoxide diffusing capacity were 80.6% and 46.9%, respectively. Mean St. George’s Respiratory Questionnaire total score was 47.0, and mean Cough-Visual Analogue Scale score was 30.5 mm. The most prevalent comorbidities reported at inclusion were gastrointestinal disorders (50.2%), including gastro-oesophageal reflux disease (47.3%) and metabolism and nutrition disorders (39.7%). At inclusion, 67.2% and 2.2% of patients were prescribed pirfenidone and nintedanib, respectively, with treatment initiated either prior to, or at the time of, inclusion. Medication prescribed concomitantly with pirfenidone included antihypertensives (54.8%), statins (37.1%) and prophylactic antithrombotics/anticoagulants (36.6%).

Conclusion The PROOF registry provides valuable demographic and clinical data from a real-world population of patients with IPF in Belgium and Luxembourg, demonstrating the high burden of comorbidities and prescribed medication in these patients. Longitudinal data from this patient population will be investigated in future analyses.

Trial registration PROOF is registered with the relevant authorities in Belgium and Luxembourg, with registration to Comité National d’Éthique et de Recherché (CNER) N201309/03 – 12 September 2013 and a notification to Comité National de Protection des Données (CNDP).

  • interstitial fibrosis
  • rare lung diseases

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0

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Footnotes

  • Contributors WAW, BB, MS, HS, CD: were involved in the conception and design of the PROOF registry. WAW, BB, MS, HS, CD: conducted data collection. KB: conducted data analysis. All authors contributed towards the interpretation of the results, and actively participated in drafting and revising this manuscript. All authors were involved in the final approval of the manuscript version to be published and agree to be accountable for all aspects of the work.

  • Funding This study was sponsored by Genentech, Inc. and F. Hoffmann-La Roche, Ltd.

  • Competing interests WAW, BB, CD and HS have received consulting and/or lecture fees from F. Hoffman-La Roche, Ltd. and Boehringer Ingelheim. KUK and KB are employees of Roche-Genentech and hold shares.

  • Patient consent Not required; this article does not contain personal medical information about an identifiable individual.

  • Ethics approval Comité National d’Éthique et de Recherché (CNER) N201309/03 Comité National de Protection des Données (CNDP).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche’s criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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