GRIPHON Subgroup Analyses
For context, GRIPHON overall population information
is shown below. Select an icon or scroll for PAH-CTD
and PAH-SSc subgroup data and post hoc analyses.
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
GRIPHON—The Largest PAH-CTD Subpopulation in a Randomized
Controlled PAH Trial (n=334)2-4
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.
PAH-CTD was a prespecified subgroup of the GRIPHON Phase 3 trial (UPTRAVI: n=167, placebo: n=167), which included:
- PAH associated with systemic sclerosis (PAH-SSc), n=170
- PAH associated with systemic lupus erythematosus (PAH-SLE), n=82
- PAH associated with mixed CTD and CTD-Other (PAH-MCTD/CTD-Other),* n=82
This analysis characterized the PAH-CTD subgroup and its response to treatment with UPTRAVI compared with the overall population.
Notable differences from overall population
- Overall tolerability was generally consistent with overall population; however, 15 (9.1%) patients on placebo and 32 (19.2%) patients on UPTRAVI in the CTD-PAH subgroup discontinued treatment due to adverse reactions vs 41 (7.1%) and 82 (14.3%) in the overall population
- Average age in the PAH-CTD subgroup (52.3 years) was slightly higher than the overall population (48.1 years), as was the proportion of female patients (90% vs 80%)
- Time from diagnosis was shorter in the PAH-CTD subgroup (mean 1.65 years vs 2.4 years in the overall study population)
SUBGROUP ANALYSIS: 41% Risk reduction of disease progression in pah-ctd patients treated with UPTRAVI
Adverse reactions in the PAH-CTD subgroup were generally consistent with the overall population. See the Important Safety Information below for the most frequent adverse reactions in the overall population. Adverse reactions in the PAH-CTD subgroup notably different from the overall population† (UPTRAVI n=167 vs placebo n=165‡): pain in extremity (18.6% vs 4.8%) and vomiting (20.4% vs 6.1%).
GRIPHON—The Largest PAH-SSc Subpopulation in a Randomized
Controlled PAH Trial (n=170)2-4
This subgroup analysis was post hoc and exploratory in nature. Sample size should be considered and results should be interpreted with caution.
PAH-SSc BASELINE PATIENT CHARACTERISTICS IN GRIPHON
PAH-SSc was a subtype of the prespecified PAH-CTD subgroup in GRIPHON. This post hoc analysis characterized the PAH-SSc subtype and its response to treatment with UPTRAVI.
Of the 334 patients with PAH-CTD in GRIPHON, 51% (n=170) had PAH-SSc.
Notable differences in PAH-SSc subtype vs overall population:
- Mean age (UPTRAVI: 59 years vs 48 years; placebo: 61 years vs 48 years)
- Asian population (5.9% vs 19.7%)
- FC III population (64.7% vs 52.5%)
- ERA + PDE-5i background therapy (36.5% vs 32.5%)
POST HOC ANALYSIS: 44% Risk Reduction of Disease Progression in PAH-SSc Patients Treated With UPTRAVI
Adverse reactions in the PAH-SSc subgroup were generally consistent with the overall population. See the Important Safety Information below for the most frequent adverse reactions in the overall population. Adverse reactions in the PAH-SSc subgroup notably different from the overall population§ (UPTRAVI n=77 vs placebo n=91‡): pain in extremity (22.1% vs 4.4%), back pain (14.3% vs 6.6%), asthenia (10.4% vs 4.4%), dizziness (22.1% vs 17.6%), and urinary tract infection (10.4% vs 6.6%).