Treatment with Esbriet (pirfenidone) slows the worsening of breathlessness in patients with more severe idiopathic pulmonary fibrosis (IPF), a post-hoc analysis of the ASCEND and CAPACITY trials shows.
The study, “Effect of pirfenidone on breathlessness in patients with idiopathic pulmonary fibrosis,” was published in the European Respiratory Journal.
Dyspnea, or breathlessness, is one of the most severe and debilitating symptoms in IPF, and has a great impact on the quality of life of people with the disease.
In the study, researchers investigated the effects of Esbriet, compared with placebo, on dyspnea severity in people with IPF.
The team pooled patient data from the Phase 3 ASCEND (NCT01366209) trial, and the CAPACITY 1 (NCT00287729) and CAPACITY 2 (NCT00287716) trials. The three trials comprised a total 1,234 participants, 50% of whom were treated with Esbriet.
Using scores from the GAP index for IPF mortality, and the University of California, San Diego Shortness of Breath Questionnaire (UCSD SOBQ), researchers compared dyspnea symptoms at the start of the trials with those after a minimum 12 months of treatment. They also assessed whether the severity of dyspnea changed over time.
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The researchers note that the GAP index and staging system provides a simple screening method for determining the average risk of mortality. Meanwhile, the UCSD SOBQ assesses a total of 24 items related to dyspnea, which are evaluated with a final score ranging from 0 to 120 — a higher total score is associated with more severe dyspnea.
The analysis showed that IPF patients with more advanced disease — those with a predict percent of forced vital capacity (FVC; a measure of lung function) below 80%, and GAP stage II/III — had a significant decrease in dyspnea worsening after treatment with Esbriet.
In fact, the positive impact of Esbriet use was only observed in this patient subgroup. No differences were seen in participants categorized as GAP stage I, or with a predicted FVC above 80%.
Patients in GAP stage II/III treated with Esbriet also showed a significant lower median change in UCSD SOBQ scores from baseline to month 12, compared with the placebo group — 9.2 vs. 13.0 points, respectively.
Additionally, those with FVC below 80% who were treated with Esbriet over 12 months also had a lower median change in UCSD SOBQ compared with placebo — 8.5 vs. 12.0 points, respectively.
In the CAPACITY trials, patients treated with a placebo did experience a reduction in lung function decline annual rate when later treated with Esbriet. However, the lung function lost during the placebo treatment stage was not recovered when the patients began treatment with Esbriet. These findings suggest that early treatment with Esbriet could have a beneficial impact for people with IPF, the researchers said.
“In conclusion, these results suggest that treatment with pirfenidone [Esbriet] slowed the worsening of patient-reported breathlessness over 12 months versus placebo in patients with GAP Stage II/III or percent predicted FVC <80%,” the team concluded.
However, the investigators noted that “further research is needed to examine the effects of pirfenidone on IPF-related symptoms including dyspnea in real-world populations.” They also said additional research is needed to confirm if changes in the “UCSD SOBQ over time is valid in a real-world population of patients with IPF.”