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Upfront combination therapy with nintedanib and anti-inflammatory agents for progressive pulmonary fibrosis: a multicentre, single-arm phase 2 study (TOP-ILD) - PubMed

4 days ago
  • #combination therapy
  • #nintedanib
  • #progressive pulmonary fibrosis
  • The study evaluated upfront combination therapy with nintedanib and anti-inflammatory agents (tacrolimus and prednisolone) for progressive pulmonary fibrosis (PPF).
  • 34 patients with PPF were enrolled in this multicentre, single-arm phase 2 study (TOP-ILD).
  • The treatment improved the relative decline slope for forced vital capacity % predicted (%FVC) from -20.9% per year before treatment to +11.2% per year after treatment.
  • Subgroup analysis showed greater improvement in patients with increased lymphocyte percentage in bronchoalveolar lavage fluid or elevated blood biomarkers.
  • Common adverse events included diarrhoea (67.6%) and hepatic dysfunction (29.4%), but were manageable with no severe cases or treatment discontinuations.
  • The study suggests early combination therapy may be a viable initial treatment strategy for PPF, but further validation in larger randomised controlled trials is needed.