11:12 uur 27-06-2016

New analysis of INPULSIS® trials demonstrates efficacy of OFEV® (nintedanib) across a range of IPF patients using broader diagnostic criteria

INGELHEIM, Germany–(BUSINESS WIRE)– New analysis of the INPULSIS ® trials show for the first time that disease progression is similar in idiopathic pulmonary fibrosis (IPF) patients identified using a broader diagnostic definition compared with the current diagnostic guidelines. The post-hoc analysis of these 1,061 patients has now been published in the American Journal of Respiratory and Critical Care Medicine.

IPF is a devastating and fatal condition. Physicians use an imaging technique called high resolution computed tomography (HRCT) to help them identify the presence of scarring (fibrosis) and specifically the presence of usual interstitial pneumonia (UIP) pattern in the lungs to ensure an accurate diagnosis of IPF. Radiological changes called “honeycombing” are a key indicator for lung fibrosis and a feature of the UIP pattern visible on HRCT. However, it can be challenging to confirm that scarring in the absence of honeycombing on HRCT meets the strict guideline criteria for a definitive diagnosis of IPF. For a large group of patients who do not receive a confirmed diagnosis of IPF according to guidelines, including those not eligible for surgical lung biopsy, the clinical course of their condition and the effectiveness of IPF treatment remains unknown. Investigations into the behaviour of the disease across diagnostic subgroups is therefore crucial.

The INPULSIS ® trials included patients with a classic diagnosis of IPF but also those patients with a clinical diagnosis of IPF who, in the absence of a surgical lung biopsy and honeycombing on HRCT, had a possible UIP pattern and the presence of traction bronchiectasis. Traction bronchiectasis is recognised as one of the most relevant CT signs of lung fibrosis. The analysis also shows that OFEV ® is effective in slowing disease progression in both diagnostic subgroups which confirms the efficacy of OFEV ® across a broad range of IPF patient types studied in Phase III and may be applicable to patients seen in clinical practice.

“In clinical practice achieving a confident diagnosis of IPF is complex. While the accuracy of IPF diagnosis is increased by discussions among experts from multi-disciplinary services at regional centres with expertise in interstitial lung diseases, community physicians may more often make a diagnosis of IPF that does not always meet the criteria laid down by international guidelines” said Ganesh Raghu, M.D., Professor of Medicine, University of Washington in the Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases at University of Washington Medical Center, Seattle, Washington, USA. “This analysis confirms for the first time that disease progression and effect of treatment in a subgroup of patients not fully meeting the diagnostic criteria is similar to those meeting the current criteria, as defined in the 2011 international guidelines for diagnosis of IPF. This has implications to consider accepting the modified criteria, as used in this study for making a diagnosis of IPF that includes presence of possible UIP pattern and traction bronchiectasis in lower lobes (despite the absence of definite honeycombing on HRCT and surgical lung biopsy), in an appropriate clinical setting and in future clinical trials.”

The subgroup analysis showed that:

  • In patients with confirmed UIP pattern, including honeycombing and/or biopsy, the adjusted annual rate of decline in FVC was −108.7 mL/year in the nintedanib group and -225.7 mL/year in the placebo group (difference versus placebo of 117.0 mL/year).
  • In patients with HRCT features of possible UIP pattern, with no honeycombing and no biopsy but the presence of traction bronchiectasis, the adjusted annual rate of decline in FVC was −122.0 mL/year in the nintedanib group and -221.0 mL/year in the placebo (difference versus placebo of 98.9 mL/year).
  • The treatment-by-subgroup interaction p-value was not significant (p=0.8139), indicating that the treatment effect of nintedanib was not different between the subgroups.
  • The treatment effect in both subgroups was also consistent with the treatment effect in the overall pooled population.
  • Adverse events were similar between subgroups.

For more information on the current international guidelines and diagnostic criteria please visit: http://www.atsjournals.org/doi/full/10.1164/rccm.2009-040GL#.VyMb-fkrLIU

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