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Landmark trials, INPULSIS® and INBUILD®, show IPF and chronic progressive fibrotic ILD patients can benefit from OFEV®1,2

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Extending the anti-fibrotic benefits of OFEV® (nintedanib) in IPF to more patients with chronic progressive fibrotic ILD

For patients with chronic progressive fibrotic interstitial lung disease, the central role of fibrosis in worsening disease provides a mechanistic target for anti-fibrotic treatment and an opportunity to slow progression across a wide range of interstitial lung diseases (ILDs) beyond idiopathic pulmonary fibrosis (IPF).1 This was the foundation for the landmark INBUILD® phase III study in chronic fibrotic ILDs with a progressive phenotype.

INBUILD® expands on the findings of the INPULSIS® study in IPF patients.1,2 The study investigated the efficacy and safety of OFEV® versus placebo in patients with chronic progressive fibrotic interstitial lung diseases (ILDs) excluding IPF. Diagnosis was based on evidence of fibrosis on high-resolution computed tomography (HRCT) along with evidence of progression of ILD. The study population was broadly representative of the expected prevalence of fibrotic disease for each ILD.1,4

 

INBUILD® study design: double-blind, placebo-controlled trial design1

INBUILD® study design: double-blind, placebo-controlled trial design
Underlying clinical ILD diagnoses in OFEV population pie chart

Together, INPULSIS® and INBUILD® provide a large and comprehensive evidence base for the treatment of ILD patients with OFEV®.1,2 This has led to the unique breadth of licence for OFEV® in patients with chronic progressive fibrotic ILD.3

Adult treatment indications for OFEV®:3

  • Idiopathic pulmonary fibrosis (IPF).
  • Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

OFEV® is the only approved treatment for chronic progressive fibrotic ILDs3

OFEV® targets fibrosis to preserve chronic progressive fibrotic ILD patients' lung capacity

Based on the findings of the INBUILD® study, OFEV® has been uniquely licensed for the treatment of chronic fibrosing ILDs with a progressive phenotype.3INBUILD® patients experienced a significant and sustained reduction in the impact of pulmonary fibrosis that was consistent with the findings of the INPULSIS® study in patients with IPF.1,2

OFEV® saved 49-57% of lung capacity that was otherwise lost to chronic progressive fibrotic ILD (including IPF) over one year.1,2

Slows FVC decline1,2

Overall, OFEV® saved 49-57% of lung capacity that was otherwise lost to chronic progressive fibrotic ILD (including IPF) over one year in the non-treatment arms.1,2 This equated to a 107.0 mL (95% CI: 65.4, 148.5; p<0.001) and 109.9 mL (95% CI: 75.9, 144.0; p<0.001) saving in forced vital capacity (FVC) per year in chronic progressive fibrotic ILD and IPF patients, respectively.1,2

Primary Endpoint Results

INBUILD® in chronic progressive fibrotic ILD (non-IPF)1

INBUILD in chronic progressive fibrotic ILD (non-IPF) - Overall population - Annual rate of decline in FVC over 52 weeks - bar chart
INBUILD in chronic progressive fibrotic ILD - UIP-like fibrotic pattern - Annual rate of decline in FVC over 52 weeks - bar chart
INBUILD® in chronic progressive fibrotic ILD (non-IPF) - Non-UIP-like fibrotic pattern -Annual rate of decline in FVC over 52 weeks -bar chart

INPULSIS® in IPF2

INPULSIS in IPF - INPULSIS - 1 and 2 pooled - Annual rate of decline in FVC over 52 weeks - bar chart
INPULSIS in IPF - INPULSIS – 1 - Annual rate of decline in FVC over 52 weeks - bar chart
INPULSIS in IPF - INPULSIS – 2 - Annual rate of decline in FVC over 52 weeks - bar chart

INBUILD® in chronic progressive fibrotic ILD (non-IPF)1

Overall population

INBUILD® in chronic progressive fibrotic ILD (non-IPF) - Overall population Change from baseline in FVC (ml) over 52 weeks - line graph

INPULSIS® in IPF2

INPULSIS® in IPF - INPULSIS - 1 and 2 pooled - Adjusted mean change from baseline in FVC (mL) over 52 weeks - line graph
INPULSIS in IPF - INPULSIS 1 - Adjusted mean change from baseline in FVC (mL) over 52 weeks - line graph
INPULSIS in IPF - INPULSIS -2 Adjusted mean change from baseline in FVC (mL) over 52 weeks - line graph

More time without serious events1,2

Importantly, this slowing of disease progression was accompanied by a reduction in the risk of clinically significant events, such as exacerbations and death (key secondary endpoint: time to first exacerbation of ILD or death).1,2 There was a non-significant risk reduction at 52 weeks in the INBUILD® population; however, statistical significance was achieved across the whole trial period. The adjudicated analysis of the INPULSIS® study also demonstrated a significant risk reduction, whereas the investigator-reported analysis did not reach significance.1-3

Secondary Endpoint Results

INBUILD® in chronic progressive fibrotic ILD (non-IPF)

Overall population

INBUILD® in chronic progressive fibrotic ILD (non-IPF) - overall population - Time to first acute exacerbation of ILD or death - line graph

INPULSIS® in IPF

INPULSIS® in IPF - INPULSIS 1 and 2: pooled - investigator-reported -Time to first acute exacerbation (non-significant) - line graph
INPULSIS® in IPF - INPULSIS 1 and 2 Pooled – Adjudicated - Time to first acute exacerbation (significant) - line graph

Consistent performance in the treatment of chronic progressive fibrotic ILDs

OFEV® demonstrated consistent efficacy, safety and tolerability profile across patients with chronic progressive fibrotic ILD, including IPF. In both INBUILD® and INPULSIS®, OFEV® slowed disease progression with a predictable and manageable adverse event profile that aligns with current practices in IPF. In both these studies, the most common adverse events were gastrointestinal (GI).1,2 Diarrhoea was the most frequent GI event reported and was mild to moderate in intensity in most patients. Of the INPULSIS® patients who experienced diarrhoeal events with OFEV®, 3.3% were severe in intensity, while 2.4% were severe for INBUILD® patients.3 Importantly, discontinuation rates due to diarrhoea were low, with 5% for INPULSIS®, and 5.7% for INBUILD®. ¶3,6

OFEV® is a multi-targeted tyrosine kinase inhibitor with anti-fibrotic and anti-inflammatory effects that inhibit key pathways leading to pulmonary fibrosis.3,7-11

Consistent tolerability profile across chronic progressive fibrotic ILD and IPF patients1,3,12

INBUILD and INPULSIS: Summary of AEs chart = PULSIS: Adverse events reported by IPF patients (pooled)
INBUILD adverse events
INPULSIS adverse events

¶Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing.3 10.0% of patients who initiated OFEV® in the INPULSIS®-ON trial discontinued due to diarrhoeal events.6

#Data are n (%) of patients with ≥1 such adverse event reported over 52 weeks (or until 28 days after last trial drug intake for patients who discontinued trial drug before week 52 in INBUILD® and INPULSIS® and reported over 52 weeks of treatment plus a 28-day post-treatment period in INPULSIS® trials. Adverse events based on MedRA preferred terms that were reported in >10% of patients in either treatment group are shown.

**Adverse event that was incapacitating or caused an inability to work or perform usual activities.

††Adverse event that resulted in death, was life-threatening, resulted in hospitalisation or prolongation of hospitalisation, resulted in persistent or clinically significant disability or incapacity, was a congenital anomaly or birth defect, or was deemed to be serious for any other reason.

The consistent performance against chronic progressive fibrotic lung disease is supported by an established mechanism of action. OFEV® is a multi-targeted tyrosine kinase inhibitor with anti-fibrotic and anti-inflammatory effects that inhibit key pathways leading to pulmonary fibrosis.3,7-11 OFEV® acts at pivotal points to dampen the amplified signalling that leads to the self-sustaining fibrosis and remodelling of lung tissue. Watch OFEV® in action here or learn more about the pathogenesis of chronic progressive fibrotic ILD here.

Still from video titled: Pathophysiology of pulmonary fibrosis

Watch OFEV® multi-targeted anti-fibrotic and anti-inflammatory action

  1. Flaherty KR et al. N Engl J Med 2019;381:1718-1727.
  2. Richeldi L et al. N Engl J Med 2014;370:2071-2082.
  3. OFEV® 100 mg and 150 mg soft capsules Summary of Product Characteristics. Boehringer Ingelheim.
  4. Olson A et al. Poster to be presented at ERS 2018.
  5. Data on file, CTR, INBUILD®, April 2020.
  6. Crestani B et al. Lancet Resp Med 2019;7(1):60–68.
  7. Wollin L et al. Eur Respir J 2019;54:1900161.
  8. Wollin L et al. Eur Respir J 2015;45(5):1434-1445.
  9. Wollin L et al. J Scleroderma Relat Disord 2019;4(3):212-218.
  10. Wollin L et al. J Pharmacol Exp Ther 2014;349(2):209-220.
  11. Hilberg F et al. Cancer Res 2008;68(12):4774-4782.
  12. Corte T et al. Respir Res. 2015;16:116. doi:10.1186/s12931-015-0276-5.

Adverse events should be reported.

UK: Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone) or by email to PV_local_uk_ireland@boehringer-ingelheim.com.

IE: Reporting forms and information can be found at www.hpra.ie/homepage/about-us/report-an-issue. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 01 291 3960 or by email to PV_local_uk_ireland@boehringer-ingelheim.com.

OFEV® is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. The recommended dose is one 150 mg capsule taken twice daily.3

PC-GB-104226 | October 2021