RT Journal Article
SR Electronic
T1 Macitentan in pulmonary hypertension (PH): Data from OPUS and OrPHeUS real-world data sets
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA5458
DO 10.1183/13993003.congress-2019.PA5458
VO 54
IS suppl 63
A1 Nick Kim
A1 Richard Channick
A1 Kelly Chin
A1 Lana Melendres-Groves
A1 Ashwin Ravichandran
A1 Monika Brand
A1 Megan Flynn
A1 Sandrine Leroy
A1 Adele Morganti
A1 Vallerie Mclaughlin
YR 2019
UL http://erj.ersjournals.com/content/54/suppl_63/PA5458.abstract
AB Introduction: The OPsumit® USers (OPUS) Registry captures real-world data on the use and safety profile of macitentan. The OPsumit® Historical USers cohort (OrPHeUS) study was conducted to supplement the OPUS data with additional new macitentan users.Aims and Objectives: To describe patient characteristics, treatment patterns, hepatic safety and survival in PH patients newly treated with macitentan in OPUS/OrPHeUS.Methods: OPUS is an ongoing, prospective, multicentre, long-term, observational drug registry (NCT02126943). OrPHeUS was a retrospective, multicentre medical chart review (NCT03197688). Here we describe patients with follow-up data in OPUS/OrPHeUS.Results: By Oct 2018, the combined OPUS/OrPHeUS population consisted of 5070 patients, of which 4979 had follow-up data. At macitentan initiation, median (Q1, Q3) age was 62 (51, 71) years and 2926 (58.8%) were on background pulmonary arterial hypertension therapy. WHO functional class (FC) was assessed in 2085 (41.9%) patients; 37.4% of those were in FC I/II and 62.6% in FC III/IV. Median (Q1, Q3) exposure to macitentan was 13.2 (4.6, 26.1) months. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN) were experienced by 162 (3.3%) patients (incidence rate (IR): 0.025 [95% CI, 0.021, 0.029] per 1 person-year); ALT/AST ≥x3 ULN and bilirubin ≥2x ULN was experienced by 39 (0.8%) patients (IR: 0.006 [95% CI, 0.004, 0.008] per 1 person-year). The 12-month Kaplan-Meier survival estimate was 92% (95% CI, 91, 93).Conclusions: This is the largest data set of PH patients newly treated with macitentan and confirms the hepatic safety profile of macitentan with no unexpected safety findings.FootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA5458.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).