INGELHEIM, Germany--(BUSINESS WIRE)--Results from the INSTAGE® trial have been presented at the 2018 European Respiratory Society (ERS) conference in Paris and published in the New England Journal of Medicine.1 The trial reports clinical data on a subset of patients with IPF and severe impairment in gas exchange, for whom only limited data exist. Data suggest that the efficacy and safety profiles of nintedanib in INSTAGE® were consistent with the profiles observed in patients with less advanced disease in the INPULSIS® and TOMORROW trials.1,2,4
INSTAGE® was conducted to investigate the efficacy and safety of nintedanib plus sildenafil vs. nintedanib monotherapy in patients with IPF and severely impaired gas exchange (DLco ≤ 35% predicted), who have largely been excluded from previous trials.1 Therefore INSTAGE® provides important clinical insights on this cohort. INSTAGE® was a randomised, double-blind, parallel-group trial with a total enrollment of 274 patients.1
The trial concluded that the addition of sildenafil on top of nintedanib did not provide significant improvement in change from baseline in SGRQ total score at week 12 (primary endpoint) compared to nintedanib therapy alone.1
“Numerically, changes in all health-related quality of life measures as well as lung function outcomes were in favour of the combination. Importantly, INSTAGE® has provided us with clinically relevant new insights about the use of nintedanib in this patient population. Changes in forced vital capacity (FVC) in patients treated with nintedanib alone in the INSTAGE® trial were highly consistent with the changes observed in patients treated with nintedanib in the INPULSIS® trials,” said Professor Martin Kolb, lead investigator of the study. “This suggests that nintedanib may have the same effect on reducing lung function decline in patients with more advanced IPF as that in patients with less advanced disease. Further, it was reassuring to note that the adverse events in these more severe patients were not different from the patients with milder disease”.
In the INSTAGE® trial, the change in FVC from baseline to 12 and 24 weeks in patients treated with nintedanib alone was −25.5 and -58.2 mL, respectively.1 This compares very well with the changes in FVC observed in the Phase III INPULSIS® trials.2 Although the study did not reach statistical significance in regards to the primary endpoint and the findings described above are considered exploratory, they provide clinically relevant new information.
No new safety signals were identified.1 The proportions of patients who reduced or interrupted nintedanib to manage adverse events, or who discontinued nintedanib prematurely due to adverse events, were similar to those in the INPULSIS® trials.1 Diarrhoea was the most frequent adverse event.1
“The INSTAGE® data are particularly important because in patients with severely impaired gas exchange, we previously only had limited data on the efficacy and safety of IPF treatments, including nintedanib,” said Dr Susanne Stowasser, Associate Head of Medicine Respiratory at Boehringer Ingelheim. “These results from the INSTAGE® trial further support the use of nintedanib across a broad range of IPF patients.”
Reassuringly, the safety and tolerability profiles of nintedanib in patients with severe impairment in gas exchange in INSTAGE® were consistent with those observed in patients with less advanced disease in earlier trials.1,2,3,4
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