The safety and tolerability of nintedanib in the treatment of idiopathic pulmonary fibrosis

Expert Opinion on Drug Safety

Volumn 16, Issue 7, 2017, Pages 857-865

  Cottin, Vincent ^a  

^a UNIVERSITÉ LYON 1   (France)

Author keywords

Adverse events; bleeding; cardiovascular disease; diarrhea; drug surveillance; liver function tests; myocardial infarction; post marketing

Indexed keywords

BILIRUBIN; CARBAMAZEPINE; ERYTHROMYCIN; HYPERICUM PERFORATUM EXTRACT; KETOCONAZOLE; LIVER ENZYME; NINTEDANIB; RIFAMPICIN; VERAPAMIL; INDOLE DERIVATIVE; PROTEIN KINASE INHIBITOR;

ADVERSE DRUG REACTION; ANOREXIA; ARTICLE; BILIRUBIN BLOOD LEVEL; BLEEDING; BRONCHITIS; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; COUGHING; DECREASED APPETITE; DIARRHEA; DRUG INTERACTION; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FIBROSING ALVEOLITIS; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; NAUSEA; NONHUMAN; PATIENT EDUCATION; PHARMACOKINETICS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; ALGORITHM; ANIMAL; CHEMICALLY INDUCED; DRUG MONITORING; IDIOPATHIC PULMONARY FIBROSIS; PATHOPHYSIOLOGY; PROCEDURES;

ALGORITHMS; ANIMALS; DIARRHEA; DRUG MONITORING; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; INDOLES; PATIENT EDUCATION AS TOPIC; PROTEIN KINASE INHIBITORS;

EID: 85020514449     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1080/14740338.2017.1338268     Document Type: Article

References (46)

1. Raghu G, Collard HR, Egan JJ, et al. Committee on idiopathic pulmonary fibrosis. An official ATS/ERS/JRS/ALAT statement:idiopathic pulmonary fibrosis:evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183:788–824.
2. Raghu G, Chen SY, Yeh WS, et al. Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older:incidence, prevalence, and survival, 2001-11. Lancet Respir Med. 2014;2:566–572.
3. Van Manen MJ, Birring SS, Vancheri C, et al. Cough in idiopathic pulmonary fibrosis. Eur Respir Rev. 2016;25:278–286.
4. Yount SE, Beaumont JL, Chen SY, et al. Health-related quality of life in patients with idiopathic pulmonary fibrosis. Lung. 2016;194:227–234.
5. Ley B, Collard HR, King TE, Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–440.
6. Collard HR, Ryerson CJ, Corte TJ, et al. Acute exacerbation of idiopathic pulmonary fibrosis. An international working group report. Am J Respir Crit Care Med. 2016;194:265–275.
7. Cottin V., The impact of emphysema in pulmonary fibrosis. Eur Respir Rev. 2013;22:153–157.
8. Behr J, Kreuter M, Hoeper MM, et al. Management of patients with idiopathic pulmonary fibrosis in clinical practice:the INSIGHTS-IPF registry. Eur Respir J. 2015;46:186–196.
9. Raghu G, Amatto VC, Behr J, et al. Comorbidities in idiopathic pulmonary fibrosis patients:a systematic literature review. Eur Respir J. 2015;46:1113–1130.
10. Bonella F, Kreuter M, Hagmeyer L, et al. Insights from the German compassionate use program of nintedanib for the treatment of idiopathic pulmonary fibrosis. Respiration. 2016;92:98–106.
11. Maher RL, Hanlon J, Hajjar ER., Clinical consequences of polypharmacy in elderly. Expert Opin Drug Saf. 2014;13:57–65.
12. Vancheri C, Cottin V, Kreuter M, et al. IPF, comorbidities and management implications. Sarcoidosis Vasc Diffuse Lung Dis. 2015;32(Suppl 1):17–23.
13. Boehringer Ingelheim. OFEV (nintedanib) Summary of Product Characteristics [internet]; 2017, Jan [cited 2017 Apr 10]. Available from:www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003821/WC500182474.pdf
14. Boehringer Ingelheim. OFEV (nintedanib) Prescribing Information [internet]; 2017, Feb [cited 2017 Apr 10]. Available from:docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Ofev/ofev.pdf
15. Raghu G, Rochwerg B, Zhang Y, et al. An official ATS/ERS/JRS/ALAT clinical practice guideline:treatment of idiopathic pulmonary fibrosis. An update of the 2011 clinical practice guideline. Am J Respir Crit Care Med. 2015;192:e3–19.•• Latest international treatment guideline for IPF.
16. Hilberg F, Roth GJ, Krssak M, et al. BIBF 1120:triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res. 2008;68:4774–4782.
17. Hostettler KE, Zhong J, Papakonstantinou E, et al. Anti-fibrotic effects of nintedanib in lung fibroblasts derived from patients with idiopathic pulmonary fibrosis. Respir Res. 2014;15:157.
18. Wollin L, Wex E, Pautsch A, et al. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015;45:1434–1445.• Mechanism of action of nintedanib in IPF.
19. Ackermann M, Kim YO, Wagner WL, et al. Effects of nintedanib on the microvascular architecture in a lung fibrosis model. Angiogenesis. 2017 Mar 10. [Epub ahead of print]. doi:10.1007/s10456-017-9543-z
20. Tandon K, Herrmann FE, Ayaub E, et al. Nintedanib attenuates the polarization of profibrotic macrophages through the inhibition of tyrosine phosphorylation on CSF1 receptor. Abstract accepted for presentation at:American Thoracic Society International Conference; 2017 19–24 May; Washington, DC, USA.
21. Richeldi L, Costabel U, Selman M, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365:1079–1087.•• Results of Phase II TOMORROW trial of nintedanib as a treatment for IPF.
22. Richeldi L, Du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370:2071–2082.•• Results of Phase III INPULSIS® trials of nintedanib as a treatment for IPF.
23. Corte T, Bonella F, Crestani B, et al. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. (Link to Creative Commons license. 2015;16:116. Available:https://creativecommons.org/licenses/by/4.0/).•• Adverse events observed in patients with IPF treated with nintedanib and recommendations for their management.
24. Costabel U, Inoue Y, Richeldi L, et al. Efficacy of nintedanib in idiopathic pulmonary fibrosis across prespecified subgroups in INPULSIS. Am J Respir Crit Care Med. 2016;193:178–185.
25. Cottin V, Taniguchi H, Richeldi L, et al. Effect of baseline emphysema on reduction in FVC decline with nintedanib in the INPULSIS trials. Poster presented at:the International Colloquium on Lung and Airway Fibrosis; 2014 Sept 20–24; Mont Tremblant, Quebec, Canada.
26. Kolb M, Richeldi L, Behr J, et al. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017;72:340–346.
27. Maher TM, Flaherty KR, Noble PW, et al. Effect of baseline FVC on lung function decline with nintedanib in patients with IPF. Eur Respir J. 2015;46(Suppl. 59):OA4499.
28. Raghu G, Crestani B, Bailes Z, et al. Effect of anti-acid medication on reduction in FVC decline with nintedanib. Eur Respir J. 2015;46(Suppl 59):OA4502.
29. Richeldi L, Cottin V, Du Bois RM, et al. Nintedanib in patients with idiopathic pulmonary fibrosis:combined evidence from the TOMORROW and INPULSIS® trials. Respir Med. 2016;113:74–79.• Pooled data from 52-week Phase II and III clinical trials of nintedanib as a treatment for IPF.
30. Richeldi L, Selman M, Kirsten A-M, et al. Long-term efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis:results from the TOMORROW trial and its open-label extension. Poster presented at:19th International Colloquium on Lung and Airway Fibrosis (ICLAF); 2016 Sept 24–28; Dublin, Ireland.
31. Crestani B, Ogura T, Pelling K, et al. Long-term treatment with nintedanib in patients with idiopathic pulmonary fibrosis:an update from INPULSIS®-ON. Paper presented at:European Respiratory Society (ERS) International Congress; 2016 Sept 3–7; London, UK.• Interim analysis of open-label extension of INPULSIS trials.
32. Wuyts WA, Kolb M, Stowasser S, et al. First data on efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis and forced vital capacity of ≤50% of predicted value. Lung. 2016;194:739–743.
33. Richeldi L, Costabel U, Inoue Y, et al. Effect of dose reductions, treatment interruptions and dose intensity on decline in lung function with nintedanib in patients with idiopathic pulmonary fibrosis (IPF):results from the INPULSIS® trials. Poster presented at:Pulmonary Fibrosis Foundation (PFF) Summit; 2015 Nov 12–14; Washington, DC, USA.
34. Crestani B, Kolb M, Wallaert B, et al. Long-term efficacy of nintedanib is maintained in patients with idiopathic pulmonary fibrosis (IPF) irrespective of dose:subgroup analysis of INPULSIS-ON. Abstract accepted for presentation at:American Thoracic Society International Conference; 2017 19–24 May; Washington, DC, USA.
35. Fletcher SV, Jones MG, Renzoni E, et al. Nintedanib for the treatment of idiopathic pulmonary fibrosis–initial clinical experience in a UK cohort. Thorax. 2015;70:A78.
36. Hughes G, Toellner H, Morris H, et al. Real world experiences:pirfenidone and nintedanib are effective and well tolerated treatments for idiopathic pulmonary fibrosis. J Clin Med. 2016;5(9):E78.
37. Noth I, Allinger A, Kaul M, et al. Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF):one-year data from post-marketing surveillance in the United States. Qjm. 2016;109(suppl 1):S51–2.
38. Pereira C, Baddini-Martinez JA, Guedes Baldi B, et al. Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil. Poster presented at:Congresso Sociedade Brasileira de Pneumologia e Tisiologia (SBPT) [Congress of the Brazilian Society of Pneumology and Physiology]; 2016 Oct 11–15; Brazil.
39. Galli JA, Pandya A, Vega-Olivo M, et al. Pirfenidone and nintedanib for pulmonary fibrosis in clinical practice:tolerability and adverse drug reactions. Respirology. 2017 Mar 20. [Epub ahead of print]. doi:10.1111/resp.13024
40. Milger K, Kneidinger N, Neurohr C, et al. Switching to nintedanib after discontinuation of pirfenidone due to adverse events in IPF. Eur Respir J. 2015;46:1217–1221.
41. Hirsh V, Blais N, Burkes R, et al. Management of diarrhea induced by epidermal growth factor receptor tyrosine kinase inhibitors. Curr Oncol. 2014;21:329–336.
42. Keefe D, Bowen J, Gibson R, et al. Noncardiac vascular toxicities of vascular endothelial growth factor inhibitors in advanced cancer:a review. Oncologist. 2011;16:432–444.
43. Delanote I, Wuyts WA, Yserbyt J, et al. Safety and efficacy of bridging to lung transplantation with antifibrotic drugs in idiopathic pulmonary fibrosis:a case series. BMC Pulm Med. 2016;16:156.
44. Collard HR, Ward AJ, Lanes S, et al. Burden of illness in idiopathic pulmonary fibrosis. J Med Econ. 2012;15:829–835.
45. Mortimer KM, Bartels D, Capapey J, et al. Characterizing idiopathic pulmonary fibrosis patients using US health plan claims data. Sarcoidosis Vasc Diffuse Lung Dis. in press.
46. Ogura T, Taniguchi H, Azuma A, et al. Safety and pharmacokinetics of nintedanib and pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J. 2015;45:1382–1392.