GRIPHON Subgroup Analyses: Time From Diagnosis
For context, GRIPHON overall population information is shown below. Select an icon or scroll for time-from-diagnosis subgroup data.
GRIPHON Phase 3 Study1:
- Long-term, multicenter, double-blind, placebo-controlled, parallel-group, event-driven study
- Enrolled 1156 patients with PAH
- UPTRAVI: n=574, placebo: n=582
- >98% WHO FC II-III at baseline
- Median duration of exposure to UPTRAVI: 1.4 years
- Maximum: 4.2 years
UPTRAVI Use Within and After 6 Months of PAH Diagnosis2
The analyses described here are post hoc and exploratory. These subgroups were not prespecified for the evaluation of the primary endpoint. Please note these analyses did not compare patients treated within 6 months of PAH diagnosis with patients treated after 6 months of diagnosis. Sample size should be considered and results should be interpreted with caution.
Baseline patient characteristics*
- GRIPHON patients were categorized based on their time from diagnosis at baseline using a 6-month threshold:
- Patients treated earlier (time from diagnosis ≤6 months, n=404)
- Patients treated later (time from diagnosis >6 months, n=752)
- This threshold has previously been used to define newly diagnosed patients with PAH3
*Patients in the ≤6 months from diagnosis subgroup were younger, more likely to be in FC II, more likely to be treatment naïve, and more likely to be from Asia/Eastern Europe compared with the overall population. Patients in the >6 months from diagnosis subgroup were more likely to be from Western Europe/Australia and North America, and had a longer mean time from diagnosis compared with the overall population.
POST HOC ANALYSIS:
TIME TO FIRST DISEASE PROGRESSION EVENT (UPTRAVI VS PLACEBO)
†Adjusted for the following covariates: baseline PAH therapy, WHO FC, sex, race, age, etiology, geographical region, baseline 6MWD, and baseline NT-proBNP.
NOTABLY DIFFERENT ADVERSE REACTIONS FROM OVERALL POPULATION
- Irrespective of time from diagnosis, the most frequently reported adverse reactions for patients treated with UPTRAVI were headache, diarrhea, and nausea
- No differences in safety profile were observed between the 2 subgroups