Age and lung function predicted the therapy’s efficacy in this group of patients.
The study, “Nintedanib can be used safely and effectively for idiopathic pulmonary fibrosis with predicted forced vital capacity ≤ 50%: A multi-center retrospective analysis,” was published in the journal PLOS One.
Ofev, marketed by Boehringer Ingelheim, is an approved treatment for IPF. As the clinical trials that supported its approval typically excluded patients with more severe disease, its efficacy and safety in patients with poor lung function remain unclear.
Thus, researchers from the Okayama Respiratory Disease Study Group in Japan analyzed the medical records of a group of 18 IPF patients with poor lung function who were treated with Ofev in a real-world clinical setting and compared its efficacy to a group of 27 patients with better lung function.
Poor lung function was defined as a forced vital capacity (FVC) of 50% predicted or less. FVC represents the volume of air in the lungs that can be exhaled after a deeply inhaled breath; it is presented as a percentage of a reference value, normally above 80%.
“The aim of this study was to investigate the safety and the efficacy of [Ofev] for patients with IPF and a predicted FVC [equal to or less than] 50%,” the researchers wrote.
All participants were from the ages of 41 to 86 years (median of 69 years), including 40 men and five women.
Patients underwent CT scans at the time of diagnosis and at least one lung function test between three months before and one week after starting Ofev treatment.
The primary endpoint of the study was a decline in FVC at six and 12 months after starting the therapy. Based on their predicted FVC, patients were classified into two groups: FVC higher than 50% (27 patients), or FVC equal to 50% or lower (18 patients).
The patient characteristics were similar between the two groups, although the ratio of forced expiratory volume in one second (FEV1), which measures how much air can be exhaled in one second, to FVC (FEV1/FVC) was significantly lower in the group with FVC greater than 50% — median of 85.3% versus 93.3% in the group with FVC equal to 50% or lower.
Emphysema — characterized by damage to alveoli, the tiny sacs in the lungs — was more frequent in patients with worse lung function (16.7% of the group), than those with better lung function (3.7%), although this difference was not statistically significant.
Lung function tests after Ofev treatment were available for 31 patients at six months and 19 patients at 12 months. The changes in FVC from baseline to six months did not differ significantly between the two groups. Similar results were found after 12 months of treatment.
In both groups, changes in predicted FVC values tended to increase after starting Ofev treatment. Although the overall survival was significantly better in those with a FVC greater than 50% compared to patients with poor lung function.
A statistical analysis found age and IPF disease severity significantly correlated with the relative change in predicted FVC. Further analysis correcting for age, sex, FEV1/FVC, and body mass index (a measure of body fat), showed both age and FEV1/FVC negatively correlated with FVC change six months after starting Ofev — meaning patients with younger age and less disease severity tended to be more likely to see a greater change in FVC after six months of treatment.
Regarding safety, the incidence of adverse events was comparable between the groups. The most frequent adverse events were an increase in liver enzymes (indicative of possible inflammation or damage to the liver) in 62.2% of patients, and diarrhea in about half of the patients (48.8%).
Overall, the results indicate that Ofev is effective even in patients with a lower FVC, the researchers concluded, noting that “age and FEV1/FVC are predictive markers of the efficacy of [Ofev].”
However, the team emphasized that “the evidence may at present be insufficient; thus, additional studies are warranted.”
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