An Early Single-Center Case Series Experience With a Recently Introduced Formulation of Inhaled Treprostinil...

Treprostinil inhalation powder produced using PRINT technology (LIQ861; delivered via the RS00 Model 8 dry powder inhaler; Yutrepia) is an FDA-approved inhaled treprostinil therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Evidence from the INSPIRE phase 3 open-label study supported long-term safety and tolerability; however, real-world implementation data remain limited.

We conducted a retrospective, single-center observational case series of consecutive patients initiated on Yutrepia in routine clinical practice between June and December 2025. Our cohort included group 1, group 3, and mixed group 1 and 3 treated at our Pulmonary Hypertension Center of Excellence. The primary objective of this study was to evaluate the real-world safety and tolerability of Yutrepia, with particular attention to airway-related adverse events (AEs), dose modification, and treatment discontinuation in routine clinical practice. Secondary outcomes included initial and maintenance doses achieved. Additional AEs recorded include dizziness, headache, nausea, hypotension, hypertension, tachycardia, fatigue, and hypoxemia. All data were calculated using a Wilson 95% confidence interval (CI) given the small sample size.

Twenty-two patients were included (mean age: 66.4 ± 13.8 years; 16 (72.7%) female patients). PH etiology was group 1 in 13 of 22 patients (59.1%), group 3 in 3 of 22 (13.6%), and mixed group 1 and 3 in 6 of 22 (27.3%). Of the 22 patients, 17 (77.27%) were on background therapy: 11 of 13 patients (84.62%) in group 1, 1 of 3 patients (33.33%) in group 3, and 5 of 6 patients (83.33%) in mixed group 1 and 3. Airway-specific AEs were documented in 8 of 22 patients (36.4%; 95% CI: 19.7%-57.0%). Shortness of breath occurred in 5 of 22 (22.7%; 95% CI: 10.1%-43.4%), cough occurred in 3 of 22 (13.6%; 95% CI: 4.7%-33.3%), and no cases of throat irritation were documented (0.0%; 95% CI: 0.0%-14.9%). Dose modification due to any AE occurred in 9 of 22 patients (40.9%; 95% CI: 23.3%-61.3%), and no patients required dose modification or discontinuation because of airway-related AEs (0.0%; 95% CI: 0.0%-14.9%). Due to the retrospective design, causal attribution of individual events to Yutrepia could not always be established.

In this retrospective, single-center case series of Yutrepia, no airway-related dose modifications or discontinuations were documented; however, the 95% confidence interval (0.0%-14.9%) indicates that clinically relevant event rates cannot be excluded given the small sample size. Overall, however, 54.5% of patients experienced an adverse event, 40.9% required dose modification, and 36.4% discontinued treatment because of an adverse event. These findings should not be interpreted as indicating that Yutrepia was broadly well tolerated. The observed frequencies of airway-related adverse events were descriptively lower for some events than those reported in selected previous studies of inhaled treprostinil, but direct comparisons cannot be made because of differences in study populations, designs, follow-up, and adverse event ascertainment. Given the small sample size and retrospective design, these findings are hypothesis-generating, and larger prospective studies are needed to define persistence, tolerability, and longer-term clinical outcomes.