Inhaled Treprostinil Improves Clinical Status in Pulmonary Hypertension-ILD

Inhaled treprostinil improved clinical status of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) over a 16-week period, according to research presented virtually at the American Thoracic Society (ATS) 2021 International Conference, held from May 14 to 19, 2021.

The findings were part of the 16-week INCREASE study (ClinicalTrials.gov Identifier: NCT02630316), which assessed the efficacy and safety of inhaled treprostinil vs placebo in patients with PH-ILD. In a post hoc analysis, researchers evaluated a composite endpoint comprising clinical improvement at week 16 in 326 patients. The composite of clinical improvement included the absence of clinical worsening, ≥10% improvement in 6-minute walk distance (6MWD) or ≥10% improvement in forced vital capacity (FVC), and a ≥30% reduction in baseline N-terminal pro-brain natriuretic peptide (NT-proBNP).

Approximately 16% of patients randomly assigned to the inhaled treprostinil group reached the composite endpoint of clinical improvement, while only 5.5% of patients in the placebo group demonstrated this improvement (P ≤.0037). Achievement of the second composite criterion was mostly related to improvements made in the 6MWD, as observed in 54 patients treated with treprostinil vs 33 patients in the placebo group.

When investigators added the absence of exacerbation of underlying disease to the definition of clinical improvement, 12.9% of patients treated with inhaled treprostinil and 4.9% given placebo were then considered to have clinical improvement.

The researchers wrote that their findings further support the view that inhaled treprostinil improves the clinical status of patients with PH-ILD, with or without underlying lung disease exacerbation. They wrote the results “are consistent with the significant results for the study’s primary endpoint previously reported” in the full analysis of the INCREASE study.

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Waxman AB, Tapson VF, Ramani G, et al. Clinical improvement in patients treated with inhaled treprostinil: a post hoc analysis of the INCREASE study. Presented at: the American Thoracic Society (ATS) International Conference 2021; May 14-19, 2021. Abstract #A1911.