Trial reportArthritis & rheumatology (Hoboken, N.J.)2021
Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- The Clinical Efficacy and Safety of Nintedanib in the Treatment of Interstitial Lung Disease Among Patients With Systemic Sclerosis: Systematic Review.Canadian respiratory journal · 2025Pooled it
- Nintedanib Therapy Alone and Combined with Mycophenolate in Patients with Systemic Sclerosis-associated Interstitial Lung Disease: Systematic Reviews and Meta-analysis.Annals of the American Thoracic Society · 2024Pooled it
- Treatment of Systemic Sclerosis-associated Interstitial Lung Disease: Evidence-based Recommendations. An Official American Thoracic Society Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2024Guideline
- Pooled it
- Trajectories of forced vital capacity in patients with systemic sclerosis-associated interstitial lung disease.Arthritis research & therapy · 2025Trial
- Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial.Rheumatology (Oxford, England) · 2023Trial
- Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial.Rheumatology (Oxford, England) · 2022Trial
- Nintedanib in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Subgroup Analyses by Autoantibody Status and Modified Rodnan Skin Thickness Score.Arthritis & rheumatology (Hoboken, N.J.) · 2022Trial
- [Clinical characteristics, efficacy and safety of antifibrotic agents in elderly patients with connective tissue disease-associated interstitial lung disease].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2025Article
- Diagnostics, Efficacy, and Safety of Immunomodulatory and Anti-Fibrotic Treatment for Interstitial Lung Disease Associated with Systemic Scleroderma (SSc-ILD).Diagnostics (Basel, Switzerland) · 2025Review
- Fibrotic Disease of the Skin and Lung: Shared Pathways, Environmental Drivers, and Therapeutic Opportunities in a Changing Climate.International journal of molecular sciences · 2025Review
- Circulating extracellular vesicles as predictive biomarkers of progressive interstitial lung disease in systemic sclerosis-a prospective cohort study.Frontiers in medicine · 2025Article
- PEComa progressed by mTOR inhibitor therapy with anti-VEGFR TKI combined with PD-1 inhibitor: a case report.Frontiers in oncology · 2025Article
- Development of a multivariable prediction model for progression of systemic sclerosis-associated interstitial lung disease.RMD open · 2024Article
- Systemic sclerosis-associated interstitial lung disease: How to manage in 2024?Rheumatology and immunology research · 2024Article
- The Plastic Interplay between Lung Regeneration Phenomena and Fibrotic Evolution: Current Challenges and Novel Therapeutic Perspectives.International journal of molecular sciences · 2023Review
- Interstitial Lung Disease in Systemic Lupus Erythematosus and Systemic Sclerosis: How Can We Manage the Challenge?International journal of molecular sciences · 2023Review
- Salt-inducible kinase 2 regulates fibrosis during bleomycin-induced lung injury.The Journal of biological chemistry · 2022Article
- Effect of Nintedanib on Progression of Systemic Sclerosis-Associated Interstitial Lung Disease Over 100 Weeks: Data From a Randomized Controlled Trial.ACR open rheumatology · 2022Article
- Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects.Respiratory research · 2022Article
Corrections and comments
- Commented on by
- Commented on byReply.2021
Authors and funding
12 authors at 8 institutions in 6 countries.
Funding
Abstract
objectiveIn the SENSCIS trial in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.
methodsIn post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of ≥5% predicted or death and absolute decline in FVC of ≥10% predicted or death.
resultsA total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of >5% to ≤10% predicted, and 3.5% and 5.2% had a decline in FVC of >10% to ≤15% predicted; 34.5% and 43.8% had a decrease in FVC of ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC of ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% confidence interval [95% CI] 0.66-1.06) (P = 0.14), and the HR for an absolute decline in FVC of ≥10% predicted was 0.64 (95% CI 0.43-0.95) (P = 0.029).
conclusionThese results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.