Pneumologie 2023; 77(S 01): S55
DOI: 10.1055/s-0043-1760999
Abstracts

Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid decline in forced vital capacity: further analyses of the SENSCIS trial* 

S Gläser
1   Klinik für Innere Medizin – Pneumologie und Infektiologie, Vivantes Klinikum, Berlin, Germany; Le-Register e.V.
,
D Khanna
2   Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI, USA
,
T Maher
3   National Heart and Lung Institute, Imperial College London, UK, National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California, Los Angeles, Ca, USA
,
E Volkmann
4   Department of Medicine, Division of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, Ca, USA
,
Y Allanore
5   Department of Rheumatology A, Descartes University, Aphp, Cochin Hospital, Paris, France
,
V Smith
6   Department of Rheumatology and Internal Medicine, Ghent University Hospital, Ghent, Belgium
,
S Assassi
7   Division of Rheumatology and Clinical Immunogenetics, University of Texas Mcgovern Medical School, Houston, TX, USA
,
M Kreuter
8   Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Heidelberg, Germany
,
A Hoffmann-Vold
9   Department of Rheumatology, Oslo University Hospital, Oslo, Norway
,
M Kuwana
10   Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan
,
C Stock
11   Boehringer Ingelheim Pharma GmbH & Co. Kg, Biberach, Germany
,
M Alves
12   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
,
S Sambevski
12   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
,
C Denton
13   University College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, UK
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Background In the SENSCIS ** trial with systemic sclerosis-associated interstitial lung disease (SSc-ILD) patients, with a mean time since first non-Raynaud symptom of 3.5 years and 52% with diffuse cutaneous SSc (dcSSc), nintedanib reduced the FVC decline (mL/year) over 52 weeks by 44% versus placebo. Risk factors for a rapid decline in FVC in patients with SSc include early SSc, elevated inflammatory markers, significant skin involvement, and dcSSc. SSc patients with risk factors for rapid ILD progression are typically given immunosuppressants but not nintedanib. We analyzed the FVC decline and the effect of nintedanib on FVC decline in subjects with these risk factors in the SENSCIS trial.

Methods In post-hoc analyses of data from SENSCIS, we analyzed the rate of decline in FVC (mL/year) over 52 weeks in all subjects and in those with early SSc (<18 months since first non-Raynaud symptom), elevated inflammatory markers (CRP≥6 mg/L and/or platelets≥330 x 109/L), or significant skin fibrosis using two approaches (modified Rodnan skin score [mRSS] 15-40 or mRSS>18) at baseline. We also analyzed the FVC decline over 52 weeks in subjects with one of these risk factors and dcSSc ([Abb. 1]).

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Abb. 1  Rate of decline in FVC (m/year) over 52 weeks in al patients and in patients withrisk factors for rapid decline in FVC at baseline in the SENSCIS trial.

Results Of 575 subjects analyzed, 79 (13.7%) had<18 months since first non- Raynaud symptom, 210 (36.5%) had elevated inflammatory markers, 172 (29.9%) had

mRSS 15-40 and 118 (20.5%) had mRSS>18. Of 299 subjects with dcSSc, 29 (9.7%) had

<18 months since first non-Raynaud symptom, 129 (43.1%) had elevated inflammatory markers, 162 (54.2%) had mRSS 15-40 and 118 (39.5%) had mRSS>18. In the placebo group, the rate of decline in FVC over 52 weeks was numerically greater in subjects with these risk factors for rapid decline in FVC compared with all subjects. Across the subgroups, the rate of decline in FVC was numerically lower in subjects treated with nintedanib than placebo (Figures).

Conclusion: The SENSCIS trial included a broad range of subjects with a fibrotic ILD complicating SSc, including those with risk factors for a rapid decline in FVC. In the placebo group, subjects with these risk factors had a more rapid decline in FVC over 52 weeks compared with the overall trial population. By targeting fibrosis with nintedanib, the rate of decline in FVC in patients with risk factors for FVC decline was reduced in patients treated with nintedanib than placebo ([Abb. 2]).

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Abb. 2  Rate of decline in FVC (m/year) over 52 weeks in all patients and in patients with dcSSc and risk factors for rapid decline in FVC at baseline in the SENSCIS trial.


Publication History

Article published online:
09 March 2023

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