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Introduction <p>Racial 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).</p> Methods <p>OPUS 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.</p> Results <p>The 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.</p> Conclusions <p>OPUS/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.</p> Trial Registration <p>OPsumit® Users Registry (OPUS), NCT02126943; Opsumit® Historical Users cohort (OrPHeUS), NCT03197688; <a href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</a>.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月19日

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  • Lana D. Melendres-Groves,
  • Richard N. Channick,
  • Kelly M. Chin,
  • Vallerie V. McLaughlin,
  • Gwen MacDonald,
  • Nicolas Martin,
  • Rose Ong,
  • Marinella Sandros,
  • Nick H. Kim

摘要

Introduction

Racial 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).

Methods

OPUS 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.

Results

The 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.

Conclusions

OPUS/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 Registration

OPsumit® Users Registry (OPUS), NCT02126943; Opsumit® Historical Users cohort (OrPHeUS), NCT03197688; www.clinicaltrials.gov.