“When systemic sclerosis [scleroderma] involves the lungs, it can be incredibly debilitating. For years I’ve watched my patients’ disease progress and have been frustrated by the fact that there weren’t any approved treatments to slow the disease from progressing,” Sindhu Johnson, director of the Toronto Scleroderma Program and a professor of medicine at the University of Toronto, said in a press release.
“I am excited to now be able to offer patients Ofev, which, by slowing the deterioration (or worsening) of the lungs, can help patients to continue to live well despite their disease,” he added.
Ofev is an approved treatment for idiopathic pulmonary fibrosis — the most common ILD — in more than 70 countries. It works by blocking a group of proteins called growth factor receptors, which are involved in lung fibrosis or scarring.
The approval was based on results of the double-blind Phase 3 SENSCIS trial (NCT02597933). It evaluated the safety and effectiveness of Ofev in 576 patients with SSc-ILD recruited at more than 100 clinical sites across 32 countries.
Participants were randomly assigned to either 150 mg of Ofev or a placebo twice daily for a year (52 weeks).
The trial’s primary goal was to assess the annual rate of decline in forced vital capacity (FVC) — a measure of lung function defined as the amount of air a person can forcibly exhale after a deep breath.
Results showed that after one year of treatment, patients using Ofev had a significantly slower decline in lung function (44% lesser decline in FVC) compared with those on a placebo. Similar benefits were recently reported from the Phase 3 INBUILD study (NCT02999178).
Safety results of SENSCIS were consistent with Ofev’s known safety profile. Diarrhea was the most frequently reported adverse event, with other common side effects including nausea, vomiting, abdominal pain, wight loss, and fatigue.
“Medical advancements, like the approval of Ofev, are a rare thing when it comes to treating conditions like systemic sclerosis,” said Martin Kolb, a respirologist at St. Joseph’s Healthcare Hamilton and director of the division of Respirology at McMaster University, also in Canada.
“We now have the unprecedented opportunity to care for our patients in a different way that offers hope by slowing down the progression of this disease,” he added.
Uli Brödl, vice president, medical and regulatory affairs, Boehringer Ingelheim (Canada), said: “With Ofev being the first therapy available in Canada to slow the rate of decline in pulmonary function for patients with SSc-ILD, it provides hope for these patients and their loved ones.”
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