This article is part of Pulmonology Advisor’s coverage of the American Thoracic Society Virtual 2020 meeting.
Treatment with LIQ861, an inhaled dry-powder form of treprostinil, was associated with significant improvements in several clinical and quality of life (QoL) measures in patients with pulmonary arterial hypertension (PAH), according to findings from the phase 3 INSPIRE study (ClinicalTrials.gov Identifier: NCT03399604) presented virtually at the American Thoracic Society (ATS) 2020 Virtual meeting, held from August 5-10, 2020.
The findings were from an exploratory efficacy end point analysis that included 121 patients with PAH who had either stable disease and were on ≤2 nonprostacyclin PAH therapies (add-on group; n=66) or had transitioned from treprostinil (transition group; n=55).
Add-on patients were treated with 4-times daily LIQ861 at a starting dose of 25 μg, which was increased in 25 μg increments per week to the most tolerated dose and until symptom relief. Patients in the transition group were treated with LIQ861 at a starting dose that was similar to treatment with their treprostinil dose, titrated in 25 μg 4-times daily increments to the most tolerated dose and until symptom relief.
Exploratory end points — namely 6-minute walk distance (6MWD), New York Heart Association Functional Class (NYHA FC), N-terminal B-type natriuretic peptide (NT-proBNP), and QoL— were assessed at month 2.
Patients at baseline were considered either NYHA FC 2 (n=80) or 3 (n=41). Approximately 75.9% of patients maintained their NYHA FC status by month 2, while 20.5% of patients improved in their FC by this time. No differences were observed between the 2 groups with regard to changes in NYHA FC.
Overall, the 6MWD increased by an average of 7.9 meters; the transition group increased by 20.1 meters and the add-on group increased by 4 meters. In addition, there was a meaningful improvement in the Minnesota Living With Heart Failure total score, defined as a >5-point reduction (mean reduction, -10.2), and also in the physical (-4.1) and emotional (-2.7) dimensions.
A higher percentage of patients met 2 or 3 PAH low-risk criteria at month 2 vs at baseline (65.1% vs 50.8%, respectively). The shift in the number of patients meeting these criteria from baseline to month 2 was more noticeable in the add-on group (41.6% to 67.3%, respectively) compared with the transition group (61.8% to 62.5%). There was no meaningful change in NT-proBNP.
The researchers also found that 85.5% of patients in the transition group preferred the dry powder inhaler over the inhalation system at week 2.
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Hill NS, Feldman JP, Sahay S, et al; for the INSPIRE Investigators. Inspire: A phase 3 open-label, multicenter study to evaluate the safety and tolerability of LIQ861 in pulmonary arterial hypertension (PAH) (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil NCT03399604) – exploratory efficacy endpoints analysis at month 2. Presented at: American Thoracic Society 2020 Virtual meeting; August 5-10, 2020. Abstract #P294.