Nintedanib is an intracellular tyrosine kinase inhibitor targeting the vascular endothelial growth factor receptor, the fibroblast growth factor receptor as well as the platelet-derived growth factor receptor. It is approved for the treatment of idiopathic pulmonary fibrosis and as a second-line combination option in some types of lung cancer. In the Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) trial, Prof. Oliver Distler (University Hospital Zurich, Switzerland) and colleagues sought to assess whether nintedanib could also be a safe and efficacious agent to treat SSc-ILD. SENSCIS is the largest randomised controlled trial conducted in patients with SSc-ILD, a disease for which there are currently no approved treatments. Primary results showed that nintedanib did slow the reduction in FVC rates over 1 year as compared with placebo.
SENSCIS was a double-blinded, multicentre, placebo-controlled, parallel-group trial that recruited 576 patients from 2015 to 2017 in 32 countries. Patients were randomised to receive either nintedanib (n=232) or placebo (n=257) in a 1:1 ratio administered in 150 mg doses twice daily. The primary endpoint was the annual rate of decline in FVC over a 52-week period. Secondary endpoints included changes in the modified Rodnan skin score and changes in the St. George’s Respiratory Questionnaire (SGRQ), which is used to evaluate skin fibrosis and respiratory status, respectively. Safety and spirometry measures were also assessed.
Patients randomised to the nintedanib group had a lower annual rate of change in FVC as compared with placebo at the 52-week mark, with divergence in rates noted after 12 weeks of treatment (-52.4 mL per year vs -93.3 mL per year; difference, 41.0 ml; 95% CI 2.9 to 79.0; P=0.04). The adjusted mean change in the modified Rodnan skin score at 52 weeks was -2.17 in the trial group and -1.96 in the placebo group (-0.21 difference; 95% CI -0.94 to 0.53). The change in SGRQ from baseline was 0.81 in the nintedanib group and -0.88 in the placebo group (95% CI -0.73 to 4.12). Adverse event rates were similar between groups and included diarrhoea, nausea, and elevations in aminotransferase levels.
Prof. Distler concluded: “The SENSCIS results provide positive news for people living with SSc-ILD and their physicians because currently there are no approved treatments. A 44% reduction in lung function decline indicates a significant slowdown in disease progression. Nintedanib could make a considerable difference to the lives of people with this rare and often life-threatening disease.”
- Distler O, et al. A5963, ATS 2019, 17-22 May, Dallas, USA.
- Distler O, et al. N Engl J Med. 2019 May 20.
Posted on
Previous Article
« Human lung organoids to study foetal RSV infection Next Article
Distinguishing between 4 different subtypes of sepsis sets the stage for individualised treatment »
« Human lung organoids to study foetal RSV infection Next Article
Distinguishing between 4 different subtypes of sepsis sets the stage for individualised treatment »
Table of Contents: ATS 2019
Featured articles
Letter from the Editor
Interview with Prof. Christian Bergmann
Treatable Traits in Chronic Inflammatory Airway Disease: Back to Basics
Treatable traits in chronic inflammatory airway disease: back to basics
Critical Care Medicine
Distinguishing between 4 different subtypes of sepsis sets the stage for individualised treatment
Stem cell therapy in acute respiratory distress syndrome improves 28-day mortality
SPICE III trial: Early sedation with dexmedetomidine in critically ill patients
SAATELLITE trial: Suvratoxumab prevents ventilator-associated Staphylococcus Aureus pneumonia in intensive care unit patients
Sleep Medicine
Million-patient study reveals gaps in long-term adherence among various sub-populations
Sleep apnoea severity has a non-linear relationship with acute myocardial infarction risk
Obstructive sleep apnoea affects morning spatial navigational memory processing in asymptomatic older individuals
Pulmonary Vascular Disease and Interstitial Lung Disease
Nintedanib reduces lung function decline in systemic sclerosis-associated ILD
Pulmonary arterial hypertension: early treatment with selexipag most effective
Long-term safety and efficacy of recombinant human pentraxin-2 in patients with idiopathic pulmonary fibrosis
Infection
Dupilumab improves outcomes in patients with severe chronic rhinosinusitis with nasal polyps and comorbid asthma
Durability of culture conversion in patients receiving ALIS for treatment-refractory MAC lung disease
E-cigarette use disrupts normal immune response to viral infections, particularly in women
Paediatric Pulmonary Medicine
Bacterial pneumonia predicts ongoing lung problems in infants hospitalised for acute respiratory failure
Aspergillus and early cystic fibrosis lung disease: does it need to be treated?
COPD
CORTICO-COP trial: eosinophil-guided therapy reduces systemic corticosteroid exposure
A randomised controlled trial of a smoking cessation smartphone application
Benralizumab does not ameliorate COPD exacerbations (GALATHEA/TERRANOVA trials)
Aclidinium bromide delays COPD exacerbation without increased MACE risk
Bench-to-Bedside (Pre-Clinical)
Human lung organoids to study foetal RSV infection
CRISPR/Cas9 genome editing therapy of hereditary pulmonary alveolar proteinosis
Cilia diagnostics in primary ciliary dyskinesia
Tuberous sclerosis complex 2 may be a novel target in pulmonary arterial hypertension therapy
Related Articles
September 10, 2020
Clinicians do not follow guidelines for diagnosing hypertension
February 3, 2022
The scope of remote healthcare in hypertension and hyperlipidaemia
October 26, 2021
Smartphone app improves BP control independent of age, sex, and BMI
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy
HEAD OFFICE
Laarderhoogtweg 25
1101 EB Amsterdam
The Netherlands
T: +31 85 4012 560
E: publishers@medicom-publishers.com