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) DL_CO <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.