High-dose treprostinil for PH-ILD yields better outcomes

In the treatment of patients with pulmonary hypertension (PH) with fibrotic interstitial lung disease (ILD), a higher dose of inhaled treprostinil or getting at least nine breaths four times daily increases the likelihood of achieving clinical improvement and preventing clinical worsening, according to a study.

Researchers conducted a post hoc analysis of the INCREASE study, a 16-week double-blind trial that randomized patients with PH due to ILD to either inhaled treprostinil or placebo. There were four treatment groups based on the number of breaths per session (<9 and ≥9 breaths) of active drug or placebo attained at 4 weeks.

The study outcomes were clinical worsening (15-percent reduction in the six-minute walk distance, cardiopulmonary hospitalization, lung transplantation, or death) or clinical improvement (15-percent increase in the six-minute walk distance with 30-percent reduction in N-terminal pro B-type natriuretic peptide [NT-proBNP] without any clinical worsening event).

At week 4, there were 70 patients receiving a dose of ≥9 breaths per session (high dose) and 79 patients <9 breaths per session (low dose) in the inhaled treprostinil arm vs 86 high dose and 67 low dose in the placebo arm.

Between weeks 4 and 16, a clinical worsening event occurred in 17.1 percent of patients on high-dose treprostinil and 22.8 percent on low-dose treprostinil as opposed to 33.7 percent and 34.3 percent of patients in the high- and low-dose placebo arms (p=0.006).

On the other hand, 15.7 percent and 12.7 percent of patients in the high- and low-dose treprostinil arms, respectively, achieved clinical improvement by week 16. These numbers were significantly greater compared with 7 percent and 1.5 percent in the respective placebo arms (p=0.003).

The findings support the early initiation and uptitration of inhaled treprostinil to a dose of at least nine breaths per session four times a day in patients with PH-ILD.