Oral Treprostinil Improves Quality of Life in Patients with Pulmonary Arterial Hypertension
Presenter: Sandeep Sahay, MD, Pulmonary Hypertension Center, Houston Methodist Lung Center, Houston, TX.
A summary of the oral abstract, Real-world patient reported outcomes using SF-12 and Emphasis-10 in patients receiving oral treprostinil: interim analysis from the adapt registry, October 17, 2021, Chest 2021.
Real-world patient-reported outcomes data reveal that 6 months of oral treprostinil improves quality of life in patients with pulmonary arterial hypertension (PAH), according to this presentation of interim data from the ADAPT registry.
“Oral treprostinil is approved to delay the disease progression and improve exercise capacity in PAH,” said Sandeep Sahay, lead author of the interim analysis report. “The ongoing ADAPT registry collects data on the real-world use of the drug. Patient-reported outcomes measuring patients’ perception of their health status and quality of life are playing an increasingly important role in treatment practices and clinical trial endpoints.”
ADAPT is an active, observational registry that follows patients with PAH for up to 78 weeks after initiating oral treprostinil. “The aim of this analysis is to explore the effect of oral treprostinil on health-related quality of life (HRQOL) at baseline and the change at month 6, and assist the correlation of HRQOL scores with risk status,” Sahay said. “We collected patients' demographics, disease characteristics, and clinical parameters as part of standard-of-care clinical visits. Along with that, HRQOL was measured using the emPHasis-10 (e10) and Short-Form 12 (SF-12) health surveys. Lower e10 and higher SF-12 scores indicate improved quality of life.”
“Risk assessment was performed using COMPERA and REVEAL 2.0 Lite calculators in patients with available data,” Sahay continued. “Patients missing highly important variables, such as 6-minute walk test results, functional class, or BNP/NT-proBNP levels, were excluded from REVEAL Lite 2.0 risk calculations.”
Data on HRQOL were collected from 109 patients at baseline; however, only 73 patients had data available at month 6. The median time since diagnosis was 1.7 years, and 33%, 30%, and 36% were receiving 0, 1, or 2 PAH background therapies, respectively. Median oral treprostinil total daily dose at month 6 was 11.3 mg.
“When we applied the risk stratification scores,” Sahay said, “27% were low risk, 62% were intermediate risk, and 11% were high risk based on the COMPERA method, and 40%, 30%, and 30%, respectively, based on the REVEAL Lite 2.0 calculator. At baseline, the mean SF-12 physical component summary and mental component summary scores were 32.5 and 51.3, respectively. At month 6, we noticed improvement in all 8 domains of the SF-12 with physical component and mental component scores increasing to 35.7 and 52.4, respectively. Data from e10 also suggested improvement, with a decline from 26.4 at baseline to 22.2 at 6 months. Both COMPERA and REVEAL Lite 2.0 showed significant correlations between the high-risk patients and worse physical component summary scores at baseline (P < .001). Higher risk by COMPERA was also significantly correlated with worse e10 scores (P < .001).”
In conclusion, Sahay said, “Patient-reported data from the ADAPT registry indicate risk status is correlated with HRQOL as measured with e10 and SF-12. Treatment with oral treprostinil improved HRQOL after 6 months. HRQOL measurement tools are important in the assessment of treatment efficacy and overall health status. Treatment considerations impacting patient quality of life improve patient satisfaction and clinically meaningful outcomes.”
Disclosures
Sandeep Sahay, MD: Altavant Sciences (Honoraria), Bayer (Consulting fee, Honoraria), BTG Specialty Pharmaceuticals (Honoraria), Gossamer (Honoraria), Janssen (Consulting fee, Honoraria), Liquidia Technologies (Honoraria), United Therapeutics (Consulting fee, Honoraria).
Reference
Sahay S, Khan A, Lachan D, et al. Real-world patient reported outcomes using SF-12 and Emphasis-10 in patients receiving oral treprostinil: interim analysis from the adapt registry. Chest 2021; 160(4) (suppl): A2290–A2291. October 1, 2021. doi: 10.1016/j.chest.2021.07.2000