Real-World Clinical Characteristics of 112 Patients with Idiopathic Pulmonary Fibrosis- Update from the Trio Health IPF Registry

Author(s)

Frantz RP1, Rane D2, Nathan SD3, Lancaster L4, Frost AE5, Chakinala MM6, Oudiz RJ7, Farber HW8
1Mayo Clinic College of Medicine, Rochester, MN, USA, 2Trio Health, Louisville, CO, USA, 3Inova Fairfax Hospital, Falls Church, VA, USA, 4Vanderbilt University Medical Center, Nashville, TN, USA, 5Institute of Academic Medicine, Houston Methodist, Houston, TX, USA, 6Washington University School of Medicine in St. Louis, St. Louis, MO, USA, 7Liu Center for Pulmonary Hypertension, Lundquist Institute for Biomedical Innovation at Harbor – UCLA Medical Center, Los Angeles, CA, USA, 8Tufts Medical Center, Boston, MA, USA

OBJECTIVES: Real-world evidence on treatment and clinical course among heterogenous idiopathic pulmonary fibrosis (IPF) patients is critical to fill gaps from clinical trials. We present baseline demographic and clinical assessments on 112 enrolled IPF patients on any approved antifibrotic therapy, from six centers between July 2019 to September 2020.

METHODS: TRIO-IPF registry is an observational, retrospective, and prospective registry. Patient demographic and clinical data are collected from US tertiary care centers. Inclusion criteria: adults >40 years, diagnosed with IPF, receiving pirfenidone and/or nintedanib within 12 months prior to enrollment, and not in a clinical trial.

RESULTS: Study population (n=112): 70% (78) male, 80% (88) white, 73% (80/109) former and 3% (3/109) current smokers, median (range) age 74 (67 to 79). At enrollment, 17% (19/109) of patients had FVC <50%, 33% (26/79) DLCO <36%, and 11% (12/105) 6-min walk distance <165 m. Gender, Age, and Physiology (GAP) score for IPF mortality was calculable for 79 patients: 25% (20/79) stage I, 58% (46/79) stage II, and 16% (13/79) stage III. Most common comorbidities are hypertension (54%, 60), GERD (52%, 58), obesity (28%, 31/112, BMI ≥ 30), CVD (24%, 27), and CAD (23%, 26). 59% (51/86) patients completed pulmonary rehab with 16% (8/51) currently in rehab. 50% (56/111) patients use oxygen therapy, 61% (34/56) with continuous use.

CONCLUSIONS: Compared to other US/European IPF registries, TRIO Health registry patients are older (mean, 74 vs 67-71), more current/former smokers (74% vs. 53%-72%), with more severe baseline DLCO (mean, 31% predicted vs. 36%-50%). Enrollment in Phase-III studies mandated FVC >50% of predicted, but in this registry 17% have FVC <50%. Further studies from the Trio registry will provide insights into un- or under-represented populations in actual clinical care.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PRS35

Topic

Clinical Outcomes, Epidemiology & Public Health, Health Service Delivery & Process of Care

Topic Subcategory

Clinical Outcomes Assessment, Disease Management, Treatment Patterns and Guidelines

Disease

Rare and Orphan Diseases, Respiratory-Related Disorders

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