Ofev Safely Slows Lung Function Decline in SSc-ILD Over Long Term

Forest Ray PhD avatar

by Forest Ray PhD |

Share this article:

Share article via email
Ofev trial update

Ofev (nintedanib) safely and effectively slowed lung function decline in people with interstitial lung disease (ILD) associated with systemic sclerosis (SSc-ILD), according to an interim analysis of the ongoing and long-term SENSCIS-ON study.

“The SENSCIS-ON trial provides important new evidence about the longer-term use of nintedanib [Ofev] in people living with SSc-ILD, showing a sustained reduction in lung function decline with a manageable safety profile,” Kristin B. Highland, MD, a lead author of the SENSCIS-ON study, said in a press release.

“These new data builds on the data already available on the use of nintedanib in SSc-ILD patients and should provide physicians with important information that will help them as they treat this serious, often life-threatening lung disease,” added Highland, who is director of the Rheumatic Lung Disease Program at the Cleveland Clinic.

The main goal of the open-label (no placebo) SENSCIS-ON study (NCT03313180) is measures of treatment safety, as recorded through the occurrence of side effects over a roughly three-year span. Medication effectiveness is also being evaluated via changes in lung function, as measured by forced vital capacity (FVC) —  the amount of air that can be forcibly exhaled from the lungs after taking a deep breath — over one year from this study’s start.

An earlier analysis of the Phase 3 SENSCIS trial (NCT02597933) found FVC decline was 44% slower among Ofev-treated patients than those receiving a placebo.

These new data show that over one year of treatment, approximately two-thirds of the 444 people enrolled in SENSCIS-ON either maintained or showed an improvement in lung health; the others experienced a worsening in FVC. Of this group, 197 patients began treatment with Ofev in SENSCIS, and 231 were randomized to placebo.

Most participants — 68% of those continuing to take Ofev from the SENSCIS study, and 68.8% of those who began using Ofev in the extension study — reported diarrhea as a side effect. Over 95% of both groups reported that their worst diarrhea was mild to moderate in intensity.

During a year of treatment, 18.3% of patients continuing Ofev and 49.4% of those switching to it had at least one dose reduction. Among these same groups, 27.9% and 42.1%, respectively, had one or more treatment interruptions, 33% and 58.7% experienced either at least one dose reduction and/or treatment interruption, and 10.2% and 23.9% permanently stopped treatment.

An abstract with these findings, “Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Data from the SENSCIS-ON Trial,” was accepted to be presented at the American Thoracic Society 2021 International Conference.

Ofev is approved to slow lung function decline in people with SSc-ILD. Given as an oral capsule, it blocks a group of proteins called growth factor receptors, that are involved in lung scarring (fibrosis).

Interstitial lung disease refers to a group of disorders that impair breathing and the lungs’ ability to transfer oxygen into the bloodstream.

“The depth and breadth of research findings from our interstitial lung disease program that we presented at this year’s ATS builds on our company’s legacy and commitment to respiratory medicine for the past 100 years,” said Craig Conoscenti, MD, lead scientist of the Chronic Fibrotic Interstitial Lung Disease Program at Boehringer Ingelheim, Ofev’s manufacturer.