Clinical trial data for nintedanib in patients with advanced IPF published

  • INSTAGE® trial results published in the New England Journal
    of Medicine1
  • Trial provides clinical data on patients with IPF and severe
    impairment in gas exchange usually excluded from clinical trials
    1
  • Efficacy and safety profile of nintedanib in patients with advanced
    IPF was consistent with that observed in patients with less advanced
    disease in earlier trials
    1,2,3,4
  • Sildenafil plus nintedanib did not provide significant benefit
    versus nintedanib alone
    1

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

~ENDS~

Please click on the link below for ‘Notes to Editors’ and
‘References’:

http://www.boehringer-ingelheim.com/press-release/instage-data-nintedanib-advanced-ipf-published

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