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Fifth publication in the New England Journal of Medicine from Firestone this year is further proof of the remarkable leadership and calibre of St. Joe’s researchers.


New research from the Firestone Institute for Respiratory Health at St. Joseph’s Healthcare Hamilton has reported the results of a combined regimen of nintedanib plus sildenafil. While this combination was not more effective than nintedanib alone in improving symptoms, when used in the treatment of idiopathic pulmonary fibrosis (IPF), it showed remarkable effects on lung function.

Dr. Martin Kolb, research director of the Firestone Institute for Respiratory Health and Professor of Medicine at McMaster University, was the first author of this international study. The study, called INSTAGE, involved 274 patients in 13 countries who had an advanced stage of IPF.

Dr. Martin Kolb, Research Director of the Firestone Institute for Respiratory Health

IPF is a respiratory disease with no known cure, involving irreversible scarring of the lung tissue. The disease is characterized by decreased lung function, dyspnea (difficult or laboured breathing), and decreased health-related quality of life. IPF has a five-year survival rate of 20 to 40 percent – which makes it much worse than most cancers. It is estimated that 12,000 Canadians suffer from IPF.

Researchers hypothesized that nintedanib and sildenafil may be effective in improving symptoms of patients with severe IPF when administered together. INSTAGE saw two groups of participants split evenly – the first group received nintedanib and sildenafil, while the second received nintedanib and a placebo.

Though the primary conclusion of the study may not have proven what researchers hypothesized, INSTAGE still provided new and very valuable clinical insights. Indeed, secondary results of the study demonstrated the safety of nintedanib when used as treatment for advanced stage IPF and suggested equal efficacy as in milder disease. Previous studies that tested the safety of nintedanib, such as INPULSIS, did so only with patients whose IPF was in a less advanced stage.

In the advanced stage IPF patient population, noted Dr. Kolb, “nintedanib may have the same effect on reducing lung function decline…as that in patients with less advanced disease.” He added, “It was reassuring to note that the adverse events in these more severe patients were not different from the patients with milder disease.” Kolb further remarked that the trial “provided important clues that support targeting the abnormal blood vessels in the stiffened lungs of IPF patients with drugs like sildenafil in order to stop progression of this disease.”

The results were published in the New England Journal of Medicine, in time for the European Respiratory Society’s International Congress 2018 in Paris this week. This annual conference brings together clinicians and scientists from around the world to share the latest innovations in the treatment of complex airway diseases. Dr. Kolb presented the INSTAGE findings at the ERS Congress on September 16, 2018.

This is the fifth study from the Firestone Institute for Respiratory Health to be published in the New England Journal of Medicine this year. In June, St. Joseph’s Healthcare Hamilton recognized the publication of four recent papers in the prestigious journal that focused on mild and severe asthma.

“St. Joe’s researchers have been leading international efforts in understanding chronic lung diseases for 40 years, and these remarkable publications are evidence of the ongoing advancements happening right here in our community,” said Dr. Gail Martin, Executive Director of the Research Institute of St. Joe’s Hamilton.

The INSTAGE study was sponsored by Boehringer Ingelheim, a global pharmaceutical company that produces nintedanib. Nintedanib is an antifibrotic drug shown to slow the progression of IPF. Research is also being conducted at St. Joseph’s Healthcare Hamilton for nintedanib’s efficacy in patients with other interstitial lung diseases.

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