Conference: 2014 International PHA Conference and Scientific Sessions
Release Date: 06.22.2014
Presentation Type: Abstracts
File Download: 2014 Conference Abstract - Vijay Josh II
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20-40% of CTEPH patients are considered unsuitable for surgery, mainly due to co-morbidities or the presence of distal disease. Riociguat, a novel sGC stimulator, was recently approved by the FDA for the treatment of inoperable CTEPH or persistent/recurrent CTEPH after surgery based on the efficacy results in a Phase III study (CHEST-1). In the open-label extension phase (CHEST-2), long-term treatment with riociguat in CTEPH patients was investigated.
Background: 20-40% of CTEPH patients are considered unsuitable for surgery, mainly due to co-morbidities or the presence of distal disease. Riociguat, a novel sGC stimulator, was recently approved by the FDA for the treatment of inoperable CTEPH or persistent/recurrent CTEPH after surgery based on the efficacy results in a Phase III study (CHEST-1). In the open-label extension phase (CHEST-2), long-term treatment with riociguat in CTEPH patients was investigated. Here we report the health outcome data collected using EQ-5D, a widely used standardized measure of health-related quality of life (HRQoL) over the first year from CHEST-2.
Methods: In CHEST-1, CTEPH patients that were inoperable or had persistent/recurrent pulmonary hypertension post-surgery were randomized to placebo or riociguat 2.5 mg dose adjustment group. Eligible patients who completed CHEST-1 were enrolled in CHEST-2, a 24 month open-label, long-term safety extension phase wherein placebo patients were switched to riociguat 2.5 mg dose adjustment group over an 8-week blinded period. HRQoL was recorded using the EQ5D instrument in both CHEST-1 (baseline and week 12), and CHEST-2 (week 12, month 6, month 9, month 12 and month 24). Descriptive statistics and 95% confidence intervals for the entire study sample were used to summarize the HRQoL for each arm across both CHEST-1 and CHEST-2. This presentation will report EQ5D data in the first year of CHEST-2 (cut off March 2013).
Results: Of the 261 patients in CHEST-1, 243 completed CHEST-1 and 237 entered CHEST-2. At baseline, patients entering CHEST-2 were on average 59 years of age, 65% female, all patients were receiving riociguat monotherapy at the start, with an average six-minute walking distance of 351 meters, and 73% inoperable and 27% with post-operative PH. At 1 year of CHEST-2, 12 (8%) patients were receiving additional PAH-specific medication. At the time of these data analyses, EQ-5D data were available for 235 (99%) and 173 (73%) patients at baseline and month 12. EQ5D score for the entire study sample was 0.646 (n=235; 95% CI: 0.614–0.678) at baseline and 0.719 (n=173; 95% CI: 0.683–0.755) at month 12. In the inoperable subgroup, the overall baseline and month 12 health utilities were 0.634 (n=170; 95% CI: 0.598–0.671) and 0.723 (n=131; 95% CI: 0.681–0.764). In the post-PEA recurrent PH subgroup, health utility increased from 0.677 (n=65; 95% CI: 0.609–0.745) at baseline to 0.707 (n=42; 95% CI: 0.634–0.781) at month 12.
Conclusions: The 1-year data of CHEST-2 demonstrate that the improvements in HRQoL seen in CHEST-1 were sustained for up to 1 year in inoperable CTEPH or persistent/recurrent CTEPH after PEA.
Type: Clinical Science