Ofev consistently slows lung function decline in SSc-ILD: Study
Data from 2 trials show benefits with approved treatment over 4 years
Lung function decline among people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) was significantly slowed over the course of about four years of treatment with Ofev (nintedanib), according to a new analysis of trial data.
The analysis was based on changes in forced vital capacity, or FVC, a measure of lung function, throughout the Phase 3 SENSCIS trial (NCT02597933) and the open-label extension SENSCIS-ON (NCT03313180). It compared participants who were first given Ofev in the main study and those who started on a placebo and switched to Ofev in the extension study.
“The trajectories of decline in FVC in the SENSCIS and SENSCIS-ON trials illustrate the progressive nature of SSc-ILD in the population studied and support the efficacy of [Ofev] on slowing decline in lung function in these patients over the longer term,” the researchers wrote.
The study, “Trajectories of forced vital capacity in patients with systemic sclerosis-associated interstitial lung disease,” was published in Arthritis Research & Therapy. Two of the study authors work at Boehringer Ingelheim, the company that markets Ofev, while other study authors have received funding from the company.
Comparison study supports effectiveness of Ofev in SSc-ILD
SSc, also known as scleroderma, is characterized by inflammation and fibrosis, or the accumulation of scar tissue, in the skin and internal organs, particularly the lungs. When scar tissue builds up in the lungs, it can lead to interstitial lung disease, known as ILD, which can damage the air sacs and make it difficult to breathe.
The progression of SSc-ILD may be assessed by measuring FVC, or the amount of air a person can forcefully exhale after taking a deep breath. In these patients, a decline in FVC is associated with an increased risk of hospitalization and mortality.
Ofev is an approved treatment for slowing lung function decline in adults with SSc-ILD. It works by blocking certain growth factor receptors involved in lung inflammation and fibrosis. The therapy’s approval was based on data from the SENSCIS trial, which showed slowed lung function decline among participants.
In SENSCIS, people with SSc-ILD were randomly assigned to receive 150 mg of Ofev, or a placebo, twice daily for at least 52 weeks, or one year. After trial completion, patients could join the long-term SENSCIS-ON study, where all received the therapy.
In both trials, FVC was measured at the study’s start, or baseline, and then after about one, three, six, and nine months. Subsequent measurements occurred at one year and up to about two years. The researchers analyzed FVC decline in those treated with Ofev over the long term, along with the effect of switching from the placebo to Ofev in the open-label study.
In patients who received nintedanib [Ofev] in the SENSCIS trial, the declines in FVC over 52 weeks in SENSCIS and SENSCIS-ON were similar, suggesting a continued effect of [the medication].
Changes in FVC were calculated by using the last on-treatment measurement in SENSCIS and the baseline measurement in SENSCIS-ON as reference values. Overall, 197 participants received Ofev in SENSCIS and continued on therapy in the long-term study, while 231 received the placebo in SENSCIS and switched to Ofev in SENSCIS-ON.
The mean FVC decline after one year of treatment in SENSCIS was lower in those given Ofev than in those who received the placebo (41.5 mL vs. 96.8 mL), with a similar effect when comparing FVC at baseline and at two years of treatment (103.8 mL vs. 204.9 mL).
The mean FVC decline after one year in SENSCIS-ON was 58.3 mL in participants who started Ofev in the parent trial, compared with 42.8 mL in those who began treatment in the open-label study.
Among those who received the placebo in the SENSCIS trial, the decline in FVC over one year of Ofev treatment in SENSCIS-ON was similar to that observed in patients taking Ofev in the parent trial, according to the researchers. This finding supports the treatment’s efficacy.
“In patients who received nintedanib [Ofev] in the SENSCIS trial, the declines in FVC over 52 weeks in SENSCIS and SENSCIS-ON were similar, suggesting a continued effect of [the medication],” the researchers wrote.
Limitations of the analysis, as pointed out by the researchers, included the gradual loss of participants during the trials’ course. Also noted was that participants who continued in the long-term study might have been those with better lung function, a slower disease progression, or who were able to better tolerate Ofev.
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