United Therapeutics Announces Increase Data Presentation at an American Thoracic Society Virtual Session
INCREASE was a phase III, multicenter, randomized, double-blinded, placebo-controlled, 16–week, parallel group study of Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease. Enrollment into the study was completed in August 2019 with a total of 326 patients. Patients were randomized in a 1:1 Tyvaso (n=163) or placebo (n=163).
The primary endpoint was to evaluate the change in 6MWD measured at peak exposure from Baseline to Week 16.
Secondary objectives of the study included:
- Change in plasma concentration of N-terminal pro-brain natriuretic peptide (NT–proBNP) from Baseline to Week 16
- Time to clinical worsening calculated as the time from randomization until one of the following criteria are met:
- Hospitalization due to a cardiopulmonary indication
- Decrease in 6MWD >15% from Baseline directly related to disease under study, at two consecutive visits, and at least 24 hours apart
- Death (all causes)
- Lung transplantation
- Change in peak 6MWD from Baseline to Week 12
- Change in trough 6MWD from Baseline to Week 15
Exploratory objectives of the study evaluated changes in peak 6MWD at Week 4 and Week 8, changes in quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ), and change in distance saturation product (DSP). Further exploratory analysis will also be performed on biomarkers and pharmacogenomics from this study.
Additional study results will be made available through scientific disclosure in upcoming peer-reviewed publications.