Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis

Kevin R. Flaherty, Charlene D. Fell, J. Terrill Huggins, Hilario Nunes, Robert Sussman, Claudia Valenzuela, Ute Petzinger, John L. Stauffer, Frank Gilberg, Monica Bengus, Marlies Wijsenbeek

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

We assessed safety and tolerability of treatment with pirfenidone (1602-2403 mg day-1) and nintedanib (200-300 mg day-1) in patients with idiopathic pulmonary fibrosis (IPF). This 24-week, single-arm, open-label, phase IV study (ClinicalTrials.gov identifier NCT02598193) enrolled patients with IPF with forced vital capacity % pred ≫50% and diffusing capacity of the lung for carbon monoxide % pred ≫30%. Before initiating nintedanib, patients had received pirfenidone for ≫16 weeks and tolerated a stable dose of ≫1602 mg day-1 for ≫28 days. The primary end-point was the proportion of patients who completed 24 weeks of combination treatment on pirfenidone (1602- 2403 mg day-1) and nintedanib (200-300 mg day-1). Investigators recorded treatment-emergent adverse events (TEAEs), attributing them to pirfenidone, nintedanib, both or neither. 89 patients were enrolled; 73 completed 24 weeks of treatment (69 meeting the primary end-point) and 16 discontinued treatment prematurely (13 due to TEAEs). 74 patients had 418 treatment-related TEAEs, of which diarrhoea, nausea and vomiting were the most common. Two patients had serious treatmentrelated TEAEs. Combined pirfenidone and nintedanib use for 24 weeks was tolerated by the majority of patients with IPF and associated with a similar pattern of TEAEs expected for either treatment alone. These results encourage further study of combination treatment with pirfenidone and nintedanib in patients with IPF.

Original languageEnglish (US)
Article number1800230
JournalEuropean Respiratory Journal
Volume52
Issue number2
DOIs
StatePublished - Aug 1 2018

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Idiopathic Pulmonary Fibrosis
Safety
Therapeutics
pirfenidone
nintedanib
Lung Volume Measurements
Vital Capacity
Carbon Monoxide
Nausea
Vomiting
Diarrhea

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine

Cite this

Flaherty, K. R., Fell, C. D., Huggins, J. T., Nunes, H., Sussman, R., Valenzuela, C., ... Wijsenbeek, M. (2018). Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis. European Respiratory Journal, 52(2), [1800230]. https://doi.org/10.1183/13993003.00230-2018
Flaherty, Kevin R. ; Fell, Charlene D. ; Huggins, J. Terrill ; Nunes, Hilario ; Sussman, Robert ; Valenzuela, Claudia ; Petzinger, Ute ; Stauffer, John L. ; Gilberg, Frank ; Bengus, Monica ; Wijsenbeek, Marlies. / Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis. In: European Respiratory Journal. 2018 ; Vol. 52, No. 2.
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Flaherty, KR, Fell, CD, Huggins, JT, Nunes, H, Sussman, R, Valenzuela, C, Petzinger, U, Stauffer, JL, Gilberg, F, Bengus, M & Wijsenbeek, M 2018, 'Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis', European Respiratory Journal, vol. 52, no. 2, 1800230. https://doi.org/10.1183/13993003.00230-2018

Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis. / Flaherty, Kevin R.; Fell, Charlene D.; Huggins, J. Terrill; Nunes, Hilario; Sussman, Robert; Valenzuela, Claudia; Petzinger, Ute; Stauffer, John L.; Gilberg, Frank; Bengus, Monica; Wijsenbeek, Marlies.

In: European Respiratory Journal, Vol. 52, No. 2, 1800230, 01.08.2018.

Research output: Contribution to journalArticle

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