How Do Patients With Idiopathic Pulmonary Fibrosis in the Real World Compare With Eligibility Criteria for Clinical Trials?

Abstract

SESSION TITLE: Diffuse Lung Disease 2 SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, November 1, 2017 at 01:30 PM - 02:30 PM PURPOSE: Few data are available describing how the characteristics of patients with idiopathic pulmonary fibrosis (IPF) in the real world compare with those eligible for participation in clinical trials. We compared the characteristics of patients with IPF enrolled in the ongoing Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry with eligibility criteria for recent clinical trials in IPF. METHODS: The IPF-PRO Registry includes patients recently diagnosed with IPF at the enrolling site. We compared the characteristics of patients in the IPF-PRO Registry (regardless of whether they were treated with antifibrotic drugs) with eligibility criteria for clinical trials. Data were analyzed from patients enrolled at 18 ILD centers in the US from 5 June 2014 to 24 October 2016 who had complete information on treatment status at baseline defined as status of nintedanib or pirfenidone use prior to, at the time of, or within 30 days after enrollment into the registry. The proportions of patients who met the key eligibility criteria for participation in the INPULSIS trials of nintedanib or the ASCEND trial of pirfenidone at enrollment were analyzed descriptively. RESULTS: Of 419 patients analyzed, 73.9% were male, median age was 70 years, 55.4% were treated with nintedanib or pirfenidone at baseline. At enrollment, median FVC was 69.8% predicted and median DLco was 41.6% predicted. All patients met the inclusion criteria for diagnosis of IPF within the previous 5 or 4 years as required in INPULSIS or ASCEND, respectively. All patients met the age criterion of ≥40 years and 92.8% met the age criteria of 40-80 years as required in INPULSIS and ASCEND, respectively. Of patients with available values at enrollment for FVC (n=371) and DLco (n=360), most patients met the trials’ eligibility criteria for lung function impairment. As required in INPULSIS, 90.3% of patients had FVC ≥50% predicted and 78.1% had DLco between 30% and 79% predicted. As required in ASCEND, 76.5% had FVC between 50% and 90% predicted and 78.6% had DLco between 30% and 90% predicted. Of patients with HRCT data available (n=412), 92.2% had an HRCT performed in the previous 12 months (as required in INPULSIS). Of patients with data available on 6-minute walk test (6MWT) at enrollment (n=281), 94.3% of patients had a 6MWT distance of ≥150 m (as required in ASCEND). CONCLUSIONS: While the designs of registries and randomized controlled trials differ, comparison of registry-enrolled patients to eligibility criteria for clinical trials may provide insights for evaluation of antifibrotic drug prescribing patterns or treatment response in a real-world setting. Although there are similarities in the patient population enrolled in clinical trials and in the IPF-PRO Registry, the IPF-PRO Registry includes a broader population. CLINICAL IMPLICATIONS: The ongoing IPF-PRO Registry will provide insights into the characteristics of patients with IPF, current practice in diagnosis and treatment, and the clinical course of the disease. Assessing the characteristics and the journey for patients with IPF enrolled in the IPF-PRO Registry will provide more information on the real-world population. Primary source of funding: Boehringer Ingelheim Pharmaceuticals, Inc. DISCLOSURE: Victoria Gamerman: Employee: Employee of Boehringer Ingelheim Pharmaceuticals, Inc. Daniel Culver: Consultant fee, speaker bureau, advisory committee, etc.: Advisory board for steering commitee (Boehringer Ingelheim) Thomas Leonard: Employee: Employee of Boehringer Ingelheim Pharmaceuticals, Inc. Craig Conoscenti: Employee: Employee of Boehringer Ingelheim Pharmaceuticals, Inc. Scott Palmer: Grant monies (from industry related sources): Grant paid by Boehringer Ingelheim to Duke Clinical Research Institute (DCRI) The following authors have nothing to disclose: Margaret Salisbury, Megan Neely, Eric Yow No Product/Research Disclosure Information