The latest analysis of Inpulsis clinical trials demonstrated that Ofev (nintedanib) for idiopathic pulmonary fibrosis slows the disease progression and that treatment results are similar using broader diagnostic criteria than required.
The data was published in the American Journal of Respiratory and Critical Care Medicine in the study “Effect of Nintedanib in Subgroups of Idiopathic Pulmonary Fibrosis by Diagnostic Criteria.”
Current IPF diagnostic criteria include: exclusion of other known causes of interstitial lung disease (ILD); the presence of an unusual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy; and specific combinations of HRCT and surgical lung biopsy patterns in patients subjected to surgical lung biopsy.
Radiological changes called “honeycombing” are a central indicator for lung fibrosis and a feature of the UIP pattern visible on HRCT. Still, it can be challenging to confirm that scarring in the absence of honeycombing on HRCT meets the exact guideline criteria for a definitive diagnosis of IPF.
In a press release, Dr. Ganesh Raghu of the University of Washington’s Division of Pulmonary and Critical Care Medicine and director of Center for Interstitial Lung Diseases at UW in Seattle, said achieving a sure diagnosis of IPF is difficult in clinical practice.
“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” Raghu said.
Given that the clinical course and response to treatment of patients who do not meet the current diagnostic criteria for IPF are unknown, investigating the behavior of disease across diagnostic subgroups is of great relevance. Differences in diagnostic criteria required for participation in IPF-related clinical trials, may lead to different patient populations being assessed at different trials.
To investigate the potential impact of diagnostic subgroups on the progression of IPF and the effect of nintedanib, researchers conducted subgroup after-analysis of patients from the Inpulsis trials with honeycombing on HRCT or confirmation of UIP by biopsy versus patients without either.
A total of 723 (68.1%) patients had honeycombing or biopsy, and 338 (31.9%) had no evidence of honeycombing nor biopsy. The analysis showed that IPF patients with possible UIP with traction bronchiectasis detected by HRCT, and who have not undergone surgical lung biopsy, had a disease form that progressed and responded similarly to nintedanib treatment as in patients with honeycombing on HRCT or confirmation of UIP by biopsy.
There was no significant treatment-by-subgroup interaction and the adverse events were identical between subgroups.