Similar Outcomes for IPF Patients Found for Esbriet, Ofev in Analysis

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by Steve Bryson, PhD |

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People with idiopathic pulmonary fibrosis (IPF) had the same mortality and hospitalization rates, and incurred similar healthcare costs, whether they were treated with Esbriet (pirfenidone) or Ofev (nintedanib), a German insurance claims analysis showed.

However, the analysis — conducted over five years and involving more than 1,000 patients — did not examine outcomes such as quality of life, lung function, and the side effects of the two IPF medications.

Thus, the researchers said, the decision to treat patients with Ofev or Esbriet should be made on a case-by-case basis.

“[Esbriet] and [Ofev] appear to be associated with equivalent mortality, hospitalization, and [health insurance] costs,” the researchers wrote. “These effect parameters however disregard patient-relevant outcomes such as quality of life and clinically relevant aspects such as lung function and adverse effects.”

Playing into the therapy decision should be patient preferences and individual risk for adverse effects, the team said.

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The analysis, conducted by researchers at the Institute of Health Economics and Health Care Management, in Germany, was reported in a study titled “Pirfenidone vs. nintedanib in patients with idiopathic pulmonary fibrosis: a retrospective cohort study.” It was published in the journal Respiratory Research.

Esbriet and Ofev are two medications approved for IPF that are designed to suppress fibrosis, or the scarring of lung tissue that characterizes the disease. Both therapies have been shown to slow disease progression, reduce respiratory-related hospitalizations, and increase patients’ survival.

To date, however, there are no specific guidelines on which medication should be recommended over the other, as there have been no controlled clinical trials directly comparing Esbriet and Ofev. Moreover, while some studies have compared these therapies’ clinical outcomes and related costs, the findings have been limited with mixed results.

“Given the inconclusive and sparse evidence, there is need to further investigate potential differences between both drugs regarding their effectiveness and related costs to guide clinicians with their treatment decisions,” the researchers wrote.

This study aimed to assess and compare the insurance-cost-related outcomes of IPF patients treated with Esbriet and Ofev. This included determining the rates of death by any cause, hospitalization due to lung disease or any cause, as well as respiratory-related healthcare costs.

Data came from health insurance claims of the Allgemeine Ortskrankenkasse, which provides health insurance for about 32% of the German population.

For a proper comparison, the analysis was adjusted (weighted) based on age, gender, and residential area. Socioeconomic background also was considered, as was the time (in years) between the first IPF diagnosis and the start of treatment. Medications for IPF prescribed six months before Esbriet or Ofev also were taken into consideration, as were co-existing medical conditions, known as comorbidities.

Over the five-year period examined in the study, 840 people diagnosed with IPF received Esbriet. These patients had a mean age of 71.9, and 207 (24.6%) were women. The Ofev group comprised 713 patients, with a mean age of 73.0, of whom 190 (26.6%) were women.

Among those treated with Esbriet, 36% died in the two years after treatment began, compared with 39% of Ofev-treated patients.

The weighted mortality rate for Esbriet-treated participants was 21.9 per 100 person-years, a measure that accounts for both the number of people and the amount of time each person was followed (100 person-years pertains to data gathered by following 100 people for one year). For those treated with Ofev, the weighted mortality rate was 24.4 per 100 person-years. These differences were not statistically significant.

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During the first year of treatment, 61% of Esbriet-treated and 57% of Ofev-treated individuals were hospitalized. Respiratory-related hospitalizations occurred in 36% of patients from both treatment groups.

Weighted hospitalization rates due to any cause were 101.3 per 100 person-years and 45.7 for respiratory-related causes among Esbriet-treated patients. In comparison, all-cause hospitalization rates for Ofev-treated participants were 92.7 per 100 person-years and 48.6 for respiratory-related reasons. Again, differences in all-cause or respiratory-related hospitalizations between the two groups were not significant.

The most common reason for all-cause hospitalizations was respiratory disease, which accounted for 48.2% of hospitalizations following Esbriet treatment and 51.5% following Ofev treatment.

The three most common diagnoses for respiratory-related hospitalizations were IPF (Esbriet: 62.8% vs. Ofev: 64.6%), lung infection (Esbriet: 19.8% vs. Ofev: 16.3%), and pulmonary hypertension (Esbriet: 10.7% vs. Ofev: 9.7%).

Regarding treatment-related costs, the team found no differences overall nor in respiratory-related expenses, apart from one exception: outpatient costs were significantly lower for Esbriet-treated patients.

The team also found that 50.7% of patients who received Esbriet discontinued treatment compared with 44.0% of those prescribed Ofev. Of these, 14.6% of Esbriet-treated patients and 5.9% of Ofev-treated patients switched medications within a period of 60 days.

Overall, the mortality and hospitalization rates for Esbriet and Ofev were deemed equivalent by researchers, as were health insurance costs. However, the team noted that the findings do not address many “patient-relevant outcomes,” to include quality of life.

“Therefore, the decision to treat with [Esbriet] and [Ofev] should be made on a case-by-case basis taking into account clinical characteristics including comorbidities and comedication, individual risk for adverse events, and patient preferences,” they concluded.

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