Pneumologie 2020; 74(S 01): 56-57
DOI: 10.1055/s-0039-3403184
Posterbegehung (PO10) – Sektion Klinische Pneumologie
Therapiefortschritte bei Kollagenose-assoziierten ILDs & pulmonaler Hypertonie
Georg Thieme Verlag KG Stuttgart · New York

Changes in FVC in the SENSCIS Trial of nintedanib in patients with systemic sclerosis-associated ILD (SSc-ILD)*

M Kreuter
1   Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Germany
,
KB Highland
2   Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA
,
A Azuma
3   Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
,
M Kuwana
4   Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan
,
TM Maher
5   National Heart and Lung Institute, Imperial College London, UK and National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK
,
MD Mayes
6   Division of Rheumatology and Clinical Immunogenetics, University of Texas Mcgovern Medical School, Houston, Texas, USA
,
G Raghu
7   University of Washington, Seattle, USA
,
M Girard
8   Boehringer Ingelheim France S. A. S., Reims, France
,
M Alves
9   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
,
M Gahlemann
10   Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland
,
O Distler
11   Department of Rheumatology, University Hospital Zurich, Switzerland
› Author Affiliations
Further Information

Publication History

Publication Date:
28 February 2020 (online)

Also available at
 
 

    Background: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in FVC (mL/year) over 52 weeks vs. placebo (primary endpoint).

    Aims: To assess effects of nintedanib on changes in FVC.

    Methods: We assessed the cumulative distribution of subjects by change in FVC % predicted at week 52 in the SENSCIS trial (based on subjects with a week 52 value). The proportions of subjects with absolute declines in FVC > 5% and > 10% predicted and relative declines in FVC (mL) > 5% and > 10% at week 52 were analysed using a worst observation carried forward approach.

    Results: At baseline, mean (SD) FVC was 72.4 (16.8) % predicted in the nintedanib group (n = 288) and 72.7 (16.6) % predicted in the placebo group (n = 288). In the nintedanib and placebo groups, respectively, absolute declines in FVC > 5% predicted were seen in 20.6% and 28.5% (OR 0.65 [95% CI 0.44, 0.96]; p = 0.03) and absolute declines in FVC > 10% predicted in 7.0% and 8.3% of subjects (OR 0.82 [0.44, 1.52]; p = 0.53). Relative declines in FVC (mL) > 5% were seen in 33.1% and 43.4% (OR 0.65 [0.46, 0.91]; p = 0.01) and relative declines in FVC (mL) > 10% in 16.7% and 18.1% (OR 0.91 [0.59, 1.41]; p = 0.68) of subjects, respectively.

    Conclusions: In patients with SSc-ILD, treatment with nintedanib is associated with a lower probability of a > 5% decline in FVC (mL or % predicted) over 52 weeks compared to placebo.

    Zoom Image
    Fig. 1 Cumulative distribution of subjects by change from baseline in FVC % predicted at week 52 in the SENSCIS trial.

    * presented at ERS 2019; ‡ presenting on behalf of the authors


    #
     
    Zoom Image
    Fig. 1 Cumulative distribution of subjects by change from baseline in FVC % predicted at week 52 in the SENSCIS trial.