Oliver Distler,1 Dinesh Khanna,2 Yannick Allanore,3 Anna Maria Hoffmann-Vold,4 Petros Sfikakis,5 Gabriele Valentini,6 Toby M Maher,7 Martin Aringer,8 Leslie Meng,9 Margarida Alves,10 Martina Gahlemann,11 Manuel Quaresma,10 Masataka Kuwana12 on behalf of the SENSCIS trial investigators
1Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland; 2Department of Medicine, University of Michigan, Ann Arbor, MI, USA; 3Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France; 4Department of Rheumatology, Oslo University Hospital, Oslo, Norway; 5National Kapodistrian University of Athens, Athens, Greece; 6Division of Rheumatology, University of Campania “Luigi Vanvitelli”, Naples, Italy; 7National Heart and Lung Institute, Imperial College London, UK and National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK; 8Division of Rheumatology, Department of Medicine III, University Medical Center & Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany; 9Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China 10Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 11Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland; 12Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan
Introduction
- While some studies have shown that decline in FVC is most rapid early in the course of SSc, SSc-ILD may also progress in patients with a longer duration of disease.1,2
- A decline in forced vital capacity (FVC) in patients with SSc-ILD is a predictor of mortality.3
- In the SENSCIS trial, nintedanib reduced the rate of decline in FVC (mL/year) in patients with SSc-ILD over 52 weeks by 44% compared with placebo, with an adverse event profile characterized mainly by gastrointestinal events.4