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POST HOC ANALYSIS: CTD SUBGROUP

GRIPHON—The Largest PAH-CTD Subpopulation in a Randomized Controlled PAH Trial (n=334)1

In an exploratory post hoc subgroup analysis, UPTRAVI® was associated with a: 41% RELATIVE RISK REDUCTION OF DISEASE PROGRESSION IN PAH-CTD PATIENTS TREATED WITH UPTRAVI® VS PLACEBO1*

Time to first disease progression event in patients with PAH-CTD
Percent of patients without an event in the PAH-CTD subgroup analysis mobile curve
41% risk reduction HR 0.59 (95% CI: 0.41, 0.85)

Baseline patient characteristics

  • 29% (n=334) of all patients in GRIPHON had PAH-CTD
  • PAH-CTD subtypes: PAH-SSc (51%, n=170), PAH-SLE (24.5%, n=82), PAH-MCTD/CTD-Other (24.5%, n=82)
  • 46% of patients in the PAH-CTD subgroup were FC II and 53% were FC III
  • 28% were receiving PDE-5i monotherapy, 23% were not receiving PAH background therapy, 20% were receiving ERA monotherapy, and 29% were receiving an ERA + PDE-5i at baseline
  • Time from diagnosis: UPTRAVI® (1.6 years), placebo (1.7 years)
  • Average age: UPTRAVI® (52 years), placebo (53 years)

Summary of primary endpoint events in patients with PAH-CTD

Events in patients with PAH-SSc mobile table

Adverse reactions in the PAH-CTD subpopulation occurring more frequently with UPTRAVI® compared with placebo by ≥3%

Adverse reactions in the PAH-SSc subgroup notably different from the overall population mobile table

PAH-CTD was a prespecified subgroup for evaluation of the primary endpoint; however, the more detailed analyses described here are post hoc. Sample size should be considered and results should be interpreted with caution.

In an exploratory post hoc subgroup analysis, UPTRAVI® was associated with a: 44% RELATIVE RISK REDUCTION OF DISEASE PROGRESSION IN PAH-SSc PATIENTS TREATED WITH UPTRAVI® VS PLACEBO1*

Time to first disease progression event in patients with PAH-SSc
Percent of patients without an event in the PAH-SSc subgroup analysis mobile curve
44% risk reduction HR 0.56 (95% CI: 0.34, 0.91)

Baseline patient characteristics

Of the 334 patients with PAH-CTD in GRIPHON, 51% (n=170) had PAH-SSc.

  • 34% FC II, 65% FC III, and 2% FC I or FC IV
  • 78% of patients were receiving PAH background therapy (36% receiving an ERA + PDE-5i, 23% receiving a PDE-5i only, and 18% receiving an ERA only)
  • Time from diagnosis: UPTRAVI® (1.5 years), placebo (1.6 years)
  • Average age: UPTRAVI® (59 years), placebo (61 years)

Summary of primary endpoint events in patients with PAH-SSc

Events in patients with PAH-SSc mobile table

Adverse reactions in the PAH-SSc subpopulation occurring more frequently with UPTRAVI® compared with placebo by ≥3%

Adverse reactions in the PAH-SSc subgroup notably different from the overall population mobile table

This subgroup analysis was post hoc and exploratory in nature. Sample size should be considered and results should be interpreted with caution.