Post Hoc Analysis: Time-From-Diagnosis Subgroups

Time-from-diagnosis Subgroups

UPTRAVI® Reduced Risk of Disease Progression When Used Within 6 Months of Diagnosis vs Placebo1

UPTRAVI® campaign 4

The information below is from a post hoc subgroup analysis of the GRIPHON trial.
View the GRIPHON pivotal data for context of the overall population.

The analysis described here is post hoc and exploratory. The subgroup was not prespecified for evaluation of the primary endpoint. Please note this analysis did not compare patients treated within 6 months of PAH diagnosis with patients treated after 6 months of PAH diagnosis. Sample size should be considered and results should be interpreted with caution.

POST HOC ANALYSIS: TIME-FROM-DIAGNOSIS SUBGROUPS 55% RISK REDUCTION OF DISEASE PROGRESSION WHEN UPTRAVI® USED WITHIN 6 MONTHS OF DIAGNOSIS VS PLACEBO1-3

Baseline patient characteristics

  • GRIPHON patients were categorized based on their time from diagnosis at baseline using a 6-month threshold:
    • 35% (n=404) of all patients in GRIPHON were treated ≤6 months from diagnosis (52% FC II and 46% FC III)*
  • 41% were receiving PDE-5i monotherapy, 39% were receiving no background PAH therapy, 10% were receiving ERA monotherapy, and 10% were receiving an ERA + PDE-5i at baseline

Notable differences in baseline characteristics from overall population

Patients in the ≤6 months from diagnosis subgroup were:

  • Younger (mean 44.2 years vs 48.1 years)
  • More likely to be in FC II (52% vs 46%)
  • More likely to be treatment naïve or receiving PDE-5i monotherapy (80% vs 53%)
  • More likely to be from Asia/Eastern Europe (70% vs 46%)
Time to first disease progression event in patients treated within 6 months of PAH diagnosis
Percent of patients treated within 6 months of PAH diagnosis without an event mobile curve
55% risk reduction HR 0.45 (95% CI: 0.33, 0.63)
Events in patients treated within 6 months of PAH diagnosis
Events in patients treated within 6 months of PAH diagnosis mobile table

Adverse reactions in ≤6 months from diagnosis subgroup notably different from overall population§

Adverse reactions in ≤6 months from diagnosis subgroup notably different from overall population mobile table
  • Irrespective of time from diagnosis, the most frequently reported adverse reactions for patients treated with UPTRAVI® were headache, diarrhea, and nausea

POST HOC ANALYSIS: TIME-FROM-DIAGNOSIS SUBGROUPS 26% RISK REDUCTION OF DISEASE PROGRESSION WHEN UPTRAVI® USED AFTER 6 MONTHS OF DIAGNOSIS VS PLACEBO1-3

Baseline patient characteristics

  • GRIPHON patients were categorized based on their time from diagnosis at baseline using a 6-month threshold:
    • 65% (n=752) of all patients in GRIPHON were treated >6 months from diagnosis (56% FC III, 42% FC II)*
  • 28% were receiving PDE-5i monotherapy, 11% were not receiving PAH background therapy, 17% were receiving ERA monotherapy, and 45% were receiving an ERA + PDE-5i at baseline

Notable differences in baseline characteristics from overall population

Patients in the >6 months from diagnosis subgroup:

  • Were more likely to be from Western Europe/Australia and North America (58% vs 45%)
  • Had a longer mean time from diagnosis (mean 3.6 years vs 2.4 years)
  • Were more likely to be receiving ERA + PDE-5i (45% vs 33%)
Time to first disease progression event in patients treated after 6 months of PAH diagnosis
Percent of patients treated after 6 months of PAH diagnosis without an event mobile curve
26% risk reduction HR 0.74 (95% CI: 0.57, 0.96)
Events in patients treated within 6 months of PAH diagnosis
Events in patients treated within and after 6 months of PAH diagnosis mobile table

Adverse reactions in >6 months from diagnosis subgroup notably different from overall population§

Adverse reactions in >6 months from diagnosis subgroup notably different from overall population mobile table
  • Irrespective of time from diagnosis, the most frequently reported adverse reactions for patients treated with UPTRAVI® were headache, diarrhea, and nausea