Observational studyAdvances in therapy2026
Characteristics, Treatment Patterns and Outcomes of Patients with Pulmonary Arterial Hypertension by Race and Ethnicity Using Real-World Data from the Combined OPUS/OrPHeUS Studies.
Observational study in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRacial and ethnic minorities are underrepresented in most pulmonary arterial hypertension (PAH) studies. The OPsumit® Users (OPUS) and Opsumit® Historical Users cohort (OrPHeUS) studies captured real-world data for US patients newly initiating macitentan. Patient characteristics, treatment patterns, and outcomes in the combined OPUS/OrPHeUS dataset are described by race (Black/African American or White) and by ethnicity (Hispanic/Latino or not Hispanic/Latino).
methodsOPUS was a prospective, observational drug registry (Apr 2014-Jun 2020; NCT02126943). OrPHeUS was a medical chart review (Oct 2013-Mar 2017; NCT03197688). All analyses are descriptive.
resultsThe OPUS/OrPHeUS PAH follow-up set comprised 4626 patients: 752/4589 (16.4%) Black/African American, 3484/4589 (75.9%) White; 517/4609 (11.2%) Hispanic/Latino, 3907/4609 (84.8%) not Hispanic/Latino. Black/African American versus White patients were slightly younger at diagnosis (median [Q1,Q3] 57 [47,66]/61 [48,71] years), with more connective tissue disease-associated PAH (33.0%/25.1%). Treatment patterns between races were similar. For Black/African American versus White patients, 1-year Kaplan-Meier estimates (95% confidence limit [CL]) for survival were 89.6% (86.8,91.8)/90.3% (89.1,91.4); freedom from all-cause hospitalization was 52.5% (48.4,56.4)/61.2% (59.4,63.0). Hispanic/Latino versus not Hispanic/Latino patients were younger at diagnosis (median [Q1,Q3] 53 [39,63]/60 [48,70] years) with more congenital heart disease-associated PAH (12.8%/5.3%) and longer median (95% CL) time from diagnosis to first, double, and triple combination PAH therapy (2.8 [2.3,3.7]/1.9 [1.7,2.2], 35.6 [29.9,46.9]/17.9 [16.3,19.9], and 213.6 [127.5,372.7]/140.4 [127.5,152.3] months, respectively). For Hispanic/Latino versus not Hispanic/Latino patients, survival estimates were 93.8% (91.0,95.8)/89.9% (88.8,90.9); freedom from all-cause hospitalization was 62.5% (57.6,67.0)/59.2% (57.4,60.9). Overall, safety profiles were similar between the groups and consistent with the known profile of macitentan.
conclusionsOPUS/OrPHeUS provides real-world insights into racial/ethnic minority groups receiving macitentan and other PAH-specific treatments in the USA. These data on treatment patterns and outcomes could help inform treatment decisions in the reported minority groups.
trial registrationOPsumit® Users Registry (OPUS), NCT02126943; Opsumit® Historical Users cohort (OrPHeUS), NCT03197688; www. CLINICALTRIALS: gov .
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