United Therapeutics Corporation detailed the new clinical and real-world evidence on pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) presented at CHEST 2021, the annual meeting of the American College of Chest Physicians. United Therapeutics and its collaborators presented 10 abstracts across a broad range of studies in PAH and PH-ILD, including pharmacokinetic (PK) data from the BREEZE study of Tyvaso DPI. ?Tyvaso DPI BREEZE pharmacokinetic data demonstrate similar exposure as Tyvaso: The CHEST meeting featured a poster detailing data from the BREEZE study of Tyvaso DPI in patients with PAH. New PK data presented at CHEST 2021 demonstrated that systemic exposure between Tyvaso DPI and Tyvaso was similar; in addition, lower variability in PK parameters were observed in Tyvaso DPI when compared with Tyvaso. PK data from a separate healthy volunteer study of Tyvaso DPI will be presented at a future scientific forum. The?BREEZE?study enrolled 51 subjects on a stable regimen of Tyvaso who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Secondary objectives of the study included changes in six-minute walk distance (6WMD), device preference and satisfaction as evaluated through the Preference Questionnaire for Inhaled Treprostinil Devices, and patient-reported PAH symptoms and impact. Top line data showing the BREEZE study met its primary objective were?released?in January 2021,?and detailed data on the primary and secondary objectives were presented in September 2021.?United Therapeutics abstracts presented at CHEST 2021 included: Tyvaso abstracts: BREEZE:?Clinical Outcomes and Pharmacokinetics (PK) of Treprostinil Inhalation Powder (Tyvaso DPI) Shelley Shapiro, MD; Leslie Spikes, MD; Ricardo Restrepo, MD; Joanna Joly, MD; Trushil Shah, MD; Jason Scoggin; Lisa Edwards, PhD; Peter Smith, PharmD; Melissa Miceli, PharmD. Inhaled treprostinil is currently delivered via a handheld ultrasonic nebulizer (Tyvaso?Inhalation System). A dry powder formulation of treprostinil and a small, portable, inhaler (Tyvaso DPI) is in development for PAH. In patients with PAH, transition from Tyvaso to Tyvaso DPI was well-tolerated with significant improvements in 6MWD, device preference and satisfaction, and patient reported outcomes. Despite a 33% higher peak serum concentration (Cmax) observed for Tyvaso DPI vs. Tyvaso, the adverse event profiles were similar. Between-subject variability for area under the curve (AUC) and Cmax parameters was similar within treatment.? Dose-Response Analysis of Inhaled Treprostinil in Pulmonary Hypertension Associated with Interstitial Lung Disease and Its Effects on Clinical Worsening. Victor Tapson, MD; Steven Nathan, MD, PhD; Micah Fisher, MD; H. James Ford, MD; James Gagermeier, MD; Joseph Parambil, MD; Amresh Raina, MD; Dianne Zwicke, MD; Alicia Gerke, MD; Eric Shen, PharmD; Dasum Lee, MS; Youlan Rao, PhD; Aaron Waxman, MD. In a post-hoc analysis of patients with PH-ILD in the INCREASE trial, patients were divided into two dose groups, less than nine breaths per session and nine breaths per session and above. The higher doses of inhaled treprostinil were associated with a lower risk of clinical worsening. These results underscore the importance of inhaled treprostinil dose titration in the context of adverse event management for patients with PH-ILD. The Impact of Hemodynamic Parameters on Inhaled Treprostinil Treatment Response ? A Subgroup Analysis from the INCREASE Trial. Aaron Waxman, MD, PhD; Victor Tapson, MD; Reda Girgis, MD; James Runo, MD; Remzi Bag, MD; Arunabh Talwar, MD; Peter Smith, PharmD; Dana Johnson, PhD; Christine Park, PharmD; Steven Nathan, MD. This INCREASE post-hoc analysis evaluated the treatment effect of inhaled treprostinil on 6MWD and forced vital capacity (FVC) as a function of baseline hemodynamics in participants with PH-ILD. PH-ILD patients with higher pulmonary vascular resistance (PVR) and/or mean pulmonary artery pressure (mPAP) had a greater response to treatment. This analysis suggests higher PVR and mPAP reflect progressive pulmonary vascular remodeling and demonstrates the importance of considering pulmonary hemodynamics when treating patients with PH-ILD. Healthcare Resource Utilization and Treatment Patterns Before and After Initiation of Inhaled Treprostinil. Charles Burger, MD, FCCP; Christine Park, PharmD; Peter Classi, MSc, MBA; Andrew Nelsen, PharmD; Benjamin Wu, PharmD. In this retrospective analysis of real-world data, inhaled treprostinil was effective in reducing hospitalization, a known risk factor for poor outcomes. The benefit remained substantial even in patients on prior dual background therapy with an endothelin receptor antagonist and phosphodiesterase-5 inhibitor or soluble guanylate cyclase stimulator. Burden of Illness in Patients with Pulmonary Hypertension due to Interstitial Lung Disease: A Real-World Analysis Using US Claims Data. Gustavo Heresi, MD; Howard Castillo, NP-C; Henry Lee, PharmD; Peter Classi, MSc, MBA; Dana Stafkey-Mailey, PharmD, PhD; Kellie D. Morland, PharmD; Margaret Sketch, MPH, PharmD; Alexander Kantorovich, PharmD; Benjamin Wu, PharmD; Bonnie Dean, PhD. A retrospective cohort study of patients with PH-ILD was conducted using research databases to characterize healthcare resource utilization and costs associated with PH-ILD. Patients with PH-ILD have significantly increased utilization of healthcare resources, including inpatient admissions, and costs, following an initial diagnosis of pulmonary hypertension.