ANCHOR-RA: Multi-National Cross-Sectional Study on ILD Screening in Rheumatoid Arthritis Patients

At December 17, 2024

Design of ANCHOR-RA: a multi-national cross-sectional study on screening for interstitial lung disease in patients with rheumatoid arthritis

BMC Rheumatol. 2024 May 21;8(1):19. doi: 10.1186/s41927-024-00389-4.

Jeffrey A Sparks 1, Philippe Dieudé 2, Anna-Maria Hoffmann-Vold 3 4, Gerd R Burmester 5, Simon Lf Walsh 6, Michael Kreuter 7, Christian Stock 8, Steven Sambevski 9, Margarida Alves 9, Paul Emery 10

Affiliations

• 1 Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, #6016U, Boston, MA, 02115, USA. jsparks@bwh.harvard.edu.
• 2 Department of Rheumatology, Bichat-Claude Bernard University Hospital, Assistance Publique-Hôpitaux de Paris, INSERM UMR1152, University of Paris, Paris, France.
• 3 Department of Rheumatology, Oslo University Hospital, University of Zurich, Oslo, Norway.
• 4 Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
• 5 Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
• 6 National Heart and Lung Institute, Imperial College London, London, UK.
• 7 Center for Pulmonary Medicine, Departments of Pneumology, Critical Care & Sleep Medicine, Mainz University Medical Center and of Pulmonary, Marienhaus Clinic Mainz, Mainz, Germany.
• 8 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
• 9 Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
• 10 NIHR Leeds Biomedical Research Centre, Institute of Rheumatic and Musculoskeletal Medicine, Leeds Teaching Hospitals NHS Trust and Leeds, University of Leeds, Leeds, UK.
Abstract

Background: Patients with rheumatoid arthritis (RA) are at risk of developing interstitial lung disease (ILD), which is associated with high mortality. Screening tools based on risk factors are needed to decide which patients with RA should be screened for ILD using high-resolution computed tomography (HRCT). The ANCHOR-RA study is a multi-national cross-sectional study that will develop a multivariable model for prediction of RA-ILD, which can be used to inform screening for RA-ILD in clinical practice.

Methods: Investigators will enrol consecutive patients with RA who have ≥ 2 of the following risk factors for RA-ILD: male; current or previous smoker; age ≥ 60 years at RA diagnosis; high-positive rheumatoid factor and/or anti-cyclic citrullinated peptide (titre > 3 x upper limit of normal); presence or history of certain extra-articular manifestations of RA (vasculitis, Felty's syndrome, secondary Sjögren's syndrome, cutaneous rheumatoid nodules, serositis, and/or scleritis/uveitis); high RA disease activity in the prior 12 months. Patients previously identified as having ILD, or who have had a CT scan in the prior 2 years, will not be eligible. Participants will undergo an HRCT scan at their local site, which will be assessed centrally by two expert radiologists. Data will be collected prospectively on demographic and RA-related characteristics, patient-reported outcomes, comorbidities and pulmonary function. The primary outcomes will be the development of a probability score for RA-ILD, based on a multivariable model incorporating potential risk factors commonly assessed in clinical practice, and an estimate of the prevalence of RA-ILD in the study population. It is planned that 1200 participants will be enrolled at approximately 30 sites in the USA, UK, Germany, France, Italy, Spain.

Discussion: Data from the ANCHOR-RA study will add to the body of evidence to support recommendations for screening for RA-ILD to improve detection of this important complication of RA and enable early intervention.
Trial registration: clinicaltrials.gov NCT05855109 (submission date: 3 May 2023).

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Sindhu R Johnson 1, Elana J Bernstein 2, Marcy B Bolster 3, Jonathan H Chung 4, Sonye K Danoff 5, Michael D George 6, Dinesh Khanna 7, Gordon Guyatt 8, Reza D Mirza 8, Rohit Aggarwal 9, Aberdeen Allen Jr 10, Shervin Assassi 11, Lenore Buckley 12, Hassan A Chami 5, Douglas S Corwin 13, Paul F Dellaripa 14, Robyn T Domsic 9, Tracy J Doyle 14, Catherine Marie Falardeau 15, Tracy M Frech 16, Fiona K Gibbons 3, Monique Hinchcliff 12, Cheilonda Johnson 6, Jeffrey P Kanne 17, John S Kim 18, Sian Yik Lim 19, Scott Matson 20, Zsuzsanna H McMahan 5, Samantha J Merck 21, Kiana Nesbitt 22, Mary Beth Scholand 23, Lee Shapiro 24, Christine D Sharkey 17, Ross Summer 25, John Varga 7, Anil Warrier 26, Sandeep K Agarwal 27, Danielle Antin-Ozerkis 12, Bradford Bemiss 28, Vaidehi Chowdhary 12, Jane E Dematte D'Amico 28, Robert Hallowell 3, Alicia M Hinze 29, Patil A Injean 30, Nikhil Jiwrajka 6, Elena K Joerns 31, Joyce S Lee 32, Ashima Makol 29, Gregory C McDermott 14, Jake G Natalini 33, Justin M Oldham 7, Didem Saygin 9, Kimberly Showalter Lakin 34, Namrata Singh 35, Joshua J Solomon 36, Jeffrey A Sparks 14, Marat Turgunbaev 37, Samera Vaseer 38, Amy Turner 37, Stacey Uhl 39, Ilya Ivlev 39 Affiliations • 1 University of Toronto, Schroeder Arthritis Institute, Toronto Western Hospital, Mount Sinai Hospital, Toronto, Ontario, Canada. • 2 Columbia University Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York City. • 3 Massachusetts General Hospital, Boston. • 4 The University of Chicago Medicine, Chicago, Illinois. • 5 Johns Hopkins University School of Medicine, Baltimore, Maryland. • 6 University of Pennsylvania, Philadelphia. • 7 University of Michigan, Ann Arbor. • 8 McMaster University, Hamilton, Ontario, Canada. • 9 University of Pittsburgh, Pittsburgh, Pennsylvania. • 10 Parlin, New Jersey. • 11 University of Texas Health Science Center at Houston. • 12 Yale School of Medicine, New Haven, Connecticut. • 13 St. Luke's University Health Network, Bethlehem, Pennsylvania. • 14 Brigham and Women's Hospital, Boston, Massachusetts. • 15 Kissimmee, Florida. • 16 Vanderbilt University Medical Center, Nashville, Tennessee. • 17 University of Wisconsin School of Medicine and Public Health, Madison. • 18 University of Virginia School of Medicine, Charlottesville. • 19 Hawaii Pacific Health, Aiea. • 20 University of Kansas Medical Center, Kansas City. • 21 Saint Francis Health System, Tulsa, Oklahoma. • 22 Lansdowne, Pennsylvania. • 23 University of Utah, Salt Lake City. • 24 Albany Medical College, Albany, New York. • 25 Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. • 26 Millennium Physicians, Huntsville, Texas. • 27 Baylor College of Medicine, Houston, Texas. • 28 Northwestern University, Chicago, Illinois. • 29 Mayo Clinic, Rochester, Minnesota. • 30 Cedars-Sinai, Los Angeles, California. • 31 UT Southwestern Medical Center, Dallas, Texas. • 32 University of Colorado Denver, Aurora. • 33 New York University Langone Health, New York City. • 34 Hospital for Special Surgery, Weill Cornell Medicine, New York City. • 35 University of Washington, Seattle. • 36 National Jewish Health, Denver, Colorado. • 37 American College of Rheumatology, Atlanta, Georgia. • 38 University of Oklahoma, Oklahoma City. • 39 ECRI, Center for Clinical Evidence and Guidelines, Plymouth Meeting, Pennsylvania. 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Curr Rheumatol Rep. 2024 Sep 25. doi: 10.1007/s11926-024-01155-8. Online ahead of print. Daniel I Sullivan 1, Dana P Ascherman 2 Affiliations • 1Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, University of Pittsburgh, UPMC Montefiore Hospital, 3459 Fifth Ave, NW 628, Pittsburgh, PA, 15213, USA. dsulliva@pitt.edu. • 2Division of Rheumatology and Clinical Immunology, Department of Medicine, Abstract Purpose of review: Rheumatoid arthritis is frequently complicated by interstitial lung disease (RA-ILD), an underappreciated contributor to excess morbidity and mortality. The true prevalence of RA-ILD is difficult to define given the variability in diagnostic criteria used. The lack of standardized screening methods, an incomplete understanding of disease pathogenesis, and dearth of validated biomarkers have limited the development of controlled clinical trials for this disease. Recent findings: Numerous studies have focused on clinical, radiographic, genetic, molecular, and/or serologic markers of disease severity as well as risk of disease progression. In addition to defining valuable clinical biomarkers, these studies have provided insights regarding the pathogenesis of RA-ILD and potential therapeutic targets. Additional studies involving immunomodulatory and/or anti-fibrotic agents have assessed new therapeutic options for different stages of RA-ILD. RA-ILD continues to be a major contributor to the increased morbidity and mortality associated with RA. Advancements in our understanding of disease pathogenesis at a molecular level are necessary to drive the development of more targeted therapy.