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Authors
Melendres-Groves, Lana D. https://orcid.org/0009-0001-7964-8322
Channick, Richard N.
Chin, Kelly M.
McLaughlin, Vallerie V.
MacDonald, Gwen
Martin, Nicolas
Ong, Rose
Sandros, Marinella
Kim, Nick H.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03197688 at ClinicalTrials.govDocuments that mention this clinical trial
Macitentan and Tadalafil Combination Therapy in Patients with Pulmonary Arterial Hypertension and Cardiovascular Comorbidities: Real-World Evidence from OPUS and OrPHeUS
https://doi.org/10.1007/s12325-025-03180-0
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
https://doi.org/10.1007/s12325-025-03403-4
Macitentan in Pulmonary Arterial Hypertension Due to Congenital Heart Disease (CHD-PAH): Real-World Evidence from the OPUS/OrPHeUS Studies
https://doi.org/10.1007/s40119-024-00386-1
Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset
https://doi.org/10.1007/s40119-024-00361-w
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Funding
Funding for this research was provided by:
Johnson & Johnson
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Article History
Received: 14 August 2025
Accepted: 8 October 2025
First Online: 19 November 2025
Declarations
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: Lana D Melendres-Groves has served as a scientific committee member for Johnson & Johnson; received research grants from Aerovate, Altavant, Gossamer Bio, Johnson & Johnson, Merck, and United Therapeutics; received consultant fees from Aerovate, Bayer, Gossamer Bio, Johnson & Johnson, L.L.C, Merck and United Therapeutics. LMG is a speaker bureau for Bayer, Johnson & Johnson, Merck, and United Therapeutics. Richard N Channick served as a scientific committee member for Johnson & Johnson; served on an advisory board for Johnson & Johnson and Bayer; received research grants / support from Johnson & Johnson and United therapeutics; received speaker fees from Johnson & Johnson, and Bayer; received consultancy fees from Johnson & Johnson, Bayer and Third pole. Kelly M Chin has served as a scientific committee member for Johnson & Johnson; has received research grants/support from Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Pfizer, Merck, Gossamer Bio; has received support for travel to meetings from Johnson & Johnson; and has received consultancy fees from Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Gossamer Bio and Merck. Vallerie V McLaughlin served as a scientific committee member for Johnson & Johnson; received research grants from Aerovate, Altavant, Gossamer Bio, Johnson & Johnson, Merck, and SoniVie; and received consultant fees from Aerami, Aerovate, Altavant, Bayer, Caremark, Corvista, Gossamer Bio, Johnson & Johnson, L.L.C, Merck and United Therapeutics. Gwen MacDonald and Nicolas Martin are employees of Johnson & Johnson and hold stock/stock options in Johnson & Johnson. Rose Ong is an employee of Johnson & Johnson, holds stock/stock options in Johnson & Johnson and spouse is an employee of Roche. Marinella Sandros is an employee of Johnson & Johnson. Nick H Kim has served as a scientific committee member for Johnson & Johnson; has received research grants / support from Bellerophon, Eiger, Gossamer Bio, Lung Biotechnology, SoniVie, and Altavant; has received consultant fees from Johnson & Johnson, Bayer, Merck, United Therapeutics, Pulnovo; and speaker fees from Johnson & Johnson, Bayer, and Merck.
: The OPUS and OrPHeUS studies were conducted according to Good Pharmacoepidemiology Practices and the 2008 Declaration of Helsinki ethical principles. At each site, local ethical approval was received from independent ethics committees and institutional review boards (IRB), with protocols reviewed by the US FDA (see Supplementary Appendix for a full site list including local ethical review boards). All studies were overseen by an independent scientific committee made up of experts in PAH (Supplementary Appendix ). In OPUS, written informed consent for the publication of anonymized data was obtained from all patients, including a confidentiality clause that all records and documents pertaining to the participation of patients in the OPUS registry would be held strictly confidential and their names would not be reported in any publications resulting from the OPUS registry. Spanish translation of the informed consent form was available. In OrPHeUS, an IRB waiver was obtained, negating explicit patient consent. Separate master committees for OPUS and OrPHeUS provided overall ethical approval for the studies: IRB approvals were provided by WIRB and Quorum (now Advarra) (OPUS registry; WIRB approval number 2014-0816, Quorum Review File number 29120/Advarra Pro00035124) and WCG-IRB (OrPHeUS study; IRB numbers 2017-8051 and 2017-2348).
