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FOR US HEALTHCARE PROFESSIONALS ONLY

For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

FOR US HEALTHCARE PROFESSIONALS ONLY

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TYVASO Hemodynamics Study—assessing hemodynamics, 6MWD, safety, and pharmacokinetics2*

ENDPOINTS PATIENT CHARACTERISTICS RESULTS SAFETY

Study design

In a multicenter, nonrandomized, open-label, single-arm study, the efficacy of TYVASO* on hemodynamics and exercise capacity, safety, and pharmacokinetics was evaluated in 17 Japanese patients with PAH.2

The initial study lasted 12 weeks, and a 40-week, long-term treatment period was available for patients who wanted to continue taking TYVASO. Of the 17 patients who participated in the initial study, 16 entered the long-term extension and continued taking TYVASO until week 52.2

  • Patients initiated TYVASO at 3 breaths per session, 4 times daily, with a maximum of 9 breaths per session, 4 times daily2
  • If tolerated, the dosage was gradually increased with a minimal interval of 7 days2
  • Delivered via the TYVASO nebulizer2

Patient eligibility

  • Adult Japanese patients with PAH2
    • Hemodynamic criteria for PAH: mPAP ≥25 mm Hg, PAWP ≤15 mm Hg, PVR ≥5 WU2
    • Patients had either IPAH, HPAH, drug- or toxin-induced PAH, or PAH associated with CTD or HIV2
    • Baseline 6MWD ≥200 m2
  • If on an ERA and/or PDE-5 inhibitor or sGC stimulator, must have initiated >12 weeks prior to the trial and been on a stable dose for >4 weeks2
  • Could not currently be taking a prostacyclin2

*Additional parameters measured include WHO FC, NT-proBNP, Borg Dyspnea Score, and an MLWHF QOL questionnaire.2

Evaluating the impact of TYVASO on hemodynamic parameters2

Study endpoints

Primary Endpoint2

  • Change in PVRI from baseline to week 12*

Secondary Endpoints2

  • Other hemodynamic parameters, including PVR, mPAP, CO, and CI
  • Peak 6MWD
  • WHO FC
  • NT-proBNP levels
  • Time to clinical worsening, defined as death, transplantation, hospitalization due to worsening PAH, or initiation of additional PAH-specific therapy
  • Borg Dyspnea Score
  • MLWHF QOL

Safety Endpoints2

  • Adverse events
  • Pulmonary function test
  • Vital signs (blood pressure, pulse, and SpO2)
  • Electrocardiogram
  • Chest X‐ray
  • Arterial blood gas analysis
  • Body weight
  • Routine laboratory parameters measured in a clinical laboratory

Pharmacokinetics2

  • PK parameters, including†:
    • Cmax: maximum plasma concentration
    • AUClast: AUC from time 0 to last measurable concentration sampling time
    • T1/2: elimination half-life

*The lower PVRI measured at 15 or 30 minutes after inhalation was taken as the designated “best” PVRI at week 12.2

†Determined from the plasma concentration-time curve.2

AUC=area under the curve; CI=cardiac index; CO=cardiac output; PK=pharmacokinetics; PVRI=pulmonary vascular resistance index; SpO2=percutaneous arterial oxygen saturation.

Patients were primarily FC II with a mean 6MWD above the low-risk threshold

Study patient characteristics (N=17)2

88.2%

had IPAH or HPAH

65%

were FC II

487.8
± 112.4 m

mean 6MWD

Patient demographic data1,2 N=17
Female, n (%) 10 (58.8)
Age, mean ± SD, y 46.4 ± 15.5
Time since PAH diagnosis, mean ± SD, y 4.0 ± 4.6
NT-proBNP, mean ± SD, pg/mL 144.1 ± 213.3
PAH classification, n (%)
IPAH/HPAH 15 (88.2)
Associated with connective tissue disease 2 (11.8)
Baseline WHO FC, n (%)
II 11 (64.7)
III 6 (35.3)
Background PAH therapy, n (%)
No 1 (5.9)
Yes 16 (94.1)
ERA 3 (17.6)
ERA and PDE-5 inhibitor/sGC stimulator 13 (76.5)
Previous prostacyclin therapy, n (%)
No 8 (47.1)
Yes 9 (52.9)
Selexipag (oral) 7 (41.2)
Bereprost (oral) 2 (11.8)
Iloprost (inhalation) 1 (5.9)

SD=standard deviation.

Changes to hemodynamics and other measures after 12 weeks with TYVASO2

hemodynamics baseline compared to changes after 12 weeks with TYVASO

Other hemodynamic changes:

  • SVR and SVRI numerically improved2

There were no significant changes in PAWP, mRAP, or SvO2.2

These data are from a single-arm, uncontrolled study. Without a control group, data must be interpreted cautiously.

How could the assessment of key early indicators of PAH impact later indicators for your patients?

*Data points for NT-proBNP graph, including standard error: baseline, 144.1±213.3 pg/mL; week 12, 108.6±165.6 mg/mL.2

†The lower PVRI measured at 15 or 30 minutes after inhalation was taken as the designated “best” PVRI at week 12.2

Changes in 6MWD and FC through 1 year2*†‡

Changes in 6MWD seen as early as day 1 and sustained at 1 year2

changes in 6MWD from baseline to day 52 using TYVASO

Changes in WHO FC2

23.5% (n=4/17) of patients improved WHO FC by week 12. 31.3 (n=5/16) of patients improved WHO FC by week 52.
woman putting on earrings in bathroom mirror

These data are from a single-arm, uncontrolled study. Without a control group, data must be interpreted cautiously.

*Of the 17 patients who participated in the initial 12-week study, 16 continued taking TYVASO for an additional 40 weeks.2

†No significant changes in Borg Dyspnea Score at weeks 6, 12, or 52.2

‡QOL had mean changes from baseline in the global score of −6.6 and −5.8 at weeks 12 and 52, respectively.2

§13 out of 17 patients maintained their baseline FC at week 12, and 11 out of 16 patients maintained their FC by week 52.2

SAFETY PROFILE SIMILAR TO ESTABLISHED TYVASO AEs2

Summary of AEs over 52 weeks2

AEs related to treprostinil (reported ≥ 10%)
Headache 10 (58.8)
Cough 8 (47.1)
Throat irritation 5 (29.4)
Hot flush 4 (23.5)
Nausea 3 (17.6)
Head discomfort 3 (17.6)
Oropharyngeal discomfort 3 (17.6)
Dizziness 2 (11.8)
Oropharyngeal pain 2 (11.8)
Blood pressure decreased 2 (11.8)
Pyrexia 2 (11.8)
Diarrhea 2 (11.8)
Palpitations 2 (11.8)

No patients died, had a transplant, or were hospitalized due to worsening PAH at any point during the study.

No patient needed additional PAH-specific therapy in the main treatment period.

  • 2 patients on an ERA received add‐on therapy with a PDE-5 inhibitor or sGC stimulator in the long‐term treatment period2

These data are from a single-arm, uncontrolled study. Without a control group, data must be interpreted cautiously.