Real-world Study in Britain Confirms Ofev Is Safe and Effective IPF Treatment
The research, “Early clinical experiences with nintedanib in three UK tertiary interstitial lung disease centres,” was published in the journal Clinical and Translational Medicine.
Three clinical trials showed that Ofev slows the progression of IPF and improves patients’ lung function — two Phase 3 INPULSIS studies (NCT01335464 and NCT01335477) and the Phase 2 TOMORROW (NCT00514683) study.
A lot of IPF patients fail to meet the strict criteria required for them to take part in clinical trials of therapies or even to use approved treatments. This limits the amount of information available on Ofev’s use in real-world settings.
British researchers decided to learn more about Ofev’s real-world use by reviewing the records of 187 IPF patients at three centers in the United Kingdom. The patients, whose median age was 72, had received 150 mg of Ofev twice day before British regulators approved it in 2016. The median length of treatment was eight months.
Ofev improved or stabilized many patients’ lung function.
In terms of safety, fewer than 5 percent of the patients experienced serious adverse events. The most common events were diarrhoea, which affected 50 percent of the patients; nausea, 36 percent; loss of appetite, 24 percent; fatigue, 20 percent; and acid reflux, 18 percent. Most of the adverse events could be managed well enough that patients did not have to discontinue treatment.
The real-world findings were consistent with clinical trial results.
“In conclusion, our real-world data focusing on AEs [adverse events] and their impact on treatment with nintedanib, is similar to the findings of the INPULSIS clinical trials,” researchers wrote. ” This is one of the largest to date real-world cohort studies of nintedanib use in IPF patients.
“No new serious safety concerns have been identified,” they wrote. “Nintedanib is tolerated by the majority of patients,” and a number of patients’ lung function “remained stable or improved on treatment.”