Kristin B Highland,1 Madelon C Vonk,2 Arata Azuma,3 Maureen D Mayes,4 Martina Gahlemann,5 Margarida Alves,6 Alexandra James,6 Veronika Kohlbrenner,7 Yannick Allanore8 on behalf of the SENSCIS-ON trial investigators
1Cleveland Clinic, Cleveland, Ohio, USA; 2Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands; 3Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan; 4Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA; 5Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland; 6Boehringer Ingelheim International GmbH, Ingelheim, Germany; 7Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA; 8Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.
Introduction
- In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks by 44% compared with placebo, with adverse events that were manageable for most patients.1
- SENSCIS-ON (NCT03313180) is an open-label extension study that is collecting data on the safety and efficacy of nintedanib over the longer term.