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 language | English (US) |
|---|---|
| Article number | 1800230 |
| Journal | European Respiratory Journal |
| Volume | 52 |
| Issue number | 2 |
| DOIs | |
| State | Published - Aug 1 2018 |
| Externally published | Yes |
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All Science Journal Classification (ASJC) codes
- Pulmonary and Respiratory Medicine
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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 journal › Article
TY - JOUR
T1 - Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis
AU - Flaherty, Kevin R.
AU - Fell, Charlene D.
AU - Huggins, J. Terrill
AU - Nunes, Hilario
AU - Sussman, Robert
AU - Valenzuela, Claudia
AU - Petzinger, Ute
AU - Stauffer, John L.
AU - Gilberg, Frank
AU - Bengus, Monica
AU - Wijsenbeek, Marlies
PY - 2018/8/1
Y1 - 2018/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85051499991&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85051499991&partnerID=8YFLogxK
U2 - 10.1183/13993003.00230-2018
DO - 10.1183/13993003.00230-2018
M3 - Article
C2 - 29946005
AN - SCOPUS:85051499991
VL - 52
JO - European Respiratory Journal
JF - European Respiratory Journal
SN - 0903-1936
IS - 2
M1 - 1800230
ER -