YUTREPIA was investigated in the Phase 3 INSPIRE trial and follow-up extension study in patients with PAH1,2
STUDIED IN PROSTACYCLIN-NAÏVE AND TYVASO® TRANSITION GROUPS2
INSPIRE was a 2-month, Phase 3, open-label, multicenter trial that studied YUTREPIA in 121 patients with PAH who were NYHA FC II or III at baseline1,2
ERA=endothelin receptor antagonist; NT-proBNP=N-terminal pro B-type natriuretic peptide; NYHA FC=New York Heart Association functional class; PDE-5i=phosphodiesterase 5 inhibitor; sGC=soluble guanylate cyclase agonist.
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Dose comparison between TYVASO® nebulizer and YUTREPIA1,3
See initial results
YUTREPIA builds upon the established safety and efficacy of inhaled treprostinil solution1,2
- The safety and efficacy of inhaled treprostinil solution were initially established in a 12-week, randomized, double-blind, placebo-controlled, multicenter study of patients with pulmonary arterial hypertension (PAH) who were also receiving bosentan or sildenafil1
- The trial met the primary efficacy endpoint—at week 12, patients who received inhaled treprostinil solution had a placebo-corrected median change from baseline in peak 6MWD of 20 meters (P < 0.001)1
6MWD = 6-minute walk distance; ERA = endothelin receptor antagonist; MLHFQ = Minnesota Living with Heart Failure Questionnaire; NYHA FC = New York Heart Association functional class; PDE-5i = phosphodiesterase 5 inhibitor; QID = four times daily; sGC = soluble guanylate cyclase agonist
YUTREPIA MADE IT POSSIBLE TO TITRATE TO HIGHER THERAPEUTIC DOSES1,2
Mean dose of YUTREPIA over 2 years in patients with PAH who were naive to prostacyclin therapy or transitioning from TYVASO® in the INSPIRE trial(1,2,4)
At 1 year1,3,4
- 41.5% (n = 39/94) of patients reached a dose of ≥132.5 mcg QID (equivalent to 15 to 17 breaths of TYVASO®)
- 3 patients reached 212 mcg QID (equivalent to ≥24 breaths of TYVASO®)
At 2 years1,3,4
- 32.5% (n = 26/80) of patients reached a dose of ≥159 mcg QID (equivalent to ≥18 breaths of TYVASO®)
- 1 patient reached 238.5 mcg QID (equivalent to ≥27 breaths of TYVASO®)
All YUTREPIA doses are QID
PATIENTS TRANSITIONING FROM TYVASO® SHOWED A 19-METER IMPROVEMENT AT MONTH 22,4,
6MWD was an exploratory endpoint in patients with PAH.
PROGRESSIVE IMPROVEMENT IN 6MWD WITH ESCALATING DOSES IN PATIENTS NAÏVE TO PROSTACYCLIN THERAPY2,4,*,†,‡
Mean dose and change from baseline in 6MWD over 2 years2,4,*,†,‡
Overall, mean 6MWD at baseline was 401 meters.2
Data from the efficacy population, which included all patients who received at least 1 dose and completed at least 1 efficacy assessment.2
This post hoc analysis excluded 1 patient whose baseline 6MWD was 560 meters and 2-month 6MWD was 181 meters as the day after the later test was performed, the patient was hospitalized with influenza and voluntarily withdrew from the study.4
6MWD was an exploratory endpoint.