Kim, Nick H.
Chin, Kelly M.
McLaughlin, Vallerie V.
DuBrock, Hilary
Restrepo-Jaramillo, Ricardo
Safdar, Zeenat
MacDonald, Gwen
Martin, Nicolas
Rosenberg, Daniel
Solonets, Maria
Channick, Richard
Funding for this research was provided by:
Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson and Johnson
Article History
Received: 16 October 2023
Accepted: 14 December 2023
First Online: 7 January 2024
Change Date: 7 February 2024
Change Type: Update
Change Details: In this article the correction procedure has not been followed. Further corrections have been included
Declarations
:
: Nick H Kim served as a Scientific Committee member for Janssen Pharmaceutical Companies of Johnson & Johnson; received research grants/support from Janssen Pharmaceutical Companies of Johnson & Johnson, Bellerophon, Eiger, Gossamer Bio, Lung Biotechnology, SoniVie, and Altavant; received consultant fees from Bayer, Merck, United Therapeutics, Pulnovo, and Polarean; and received speaker fees from Janssen Pharmaceutical Companies of Johnson & Johnson and Bayer. Kelly M Chin served as a Scientific Committee member for Janssen Pharmaceutical Companies of Johnson & Johnson; received research grants/support from Janssen Pharmaceutical Companies of Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Pfizer, Merck, Gossamer Bio; received support for travel to meetings from Janssen Pharmaceutical Companies of Johnson & Johnson; and received consultancy fees from Janssen Pharmaceutical Companies of Johnson & Johnson, Altavant, Acceleron, United Therapeutics and Gossamer Bio. Vallerie V McLaughlin served as a Scientific Committee member from Janssen Pharmaceutical Companies of Johnson & Johnson; received research grants from Aerovate, Altavant, Gossamer Bio, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and SoniVie; and received consultant fees from Aerami, Aerovate, Altavant, Bayer, Caremark, Corvista, Gossamer Bio, Janssen Pharmaceutical Companies of Johnson & Johnson, L.L.C, Merck and United Therapeutics. Hilary DuBrock received consultancy fees from Janssen Pharmaceutical Companies of Johnson & Johnson, served on advisory boards for Janssen Pharmaceutical Companies of Johnson & Johnson and United Therapeutics and received grant funding from Bayer Pharmaceuticals. Ricardo Restrepo-Jaramillo received research grants/support from Janssen Pharmaceutical Companies of Johnson & Johnson, Bayer and United Therapeutics; received consultancy fees from Bayer, Merck, United Therapeutics; and received speaker fees from Janssen Pharmaceutical Companies of Johnson & Johnson, United Therapeutics and Bayer. Zeenat Safdar received speaker fees, served on an advisory board and received consultancy fees from Acceleron, Boehringer Ingelheim, Genentech, Janssen Pharmaceutical Companies of Johnson & Johnson and United Therapeutics. Gwen MacDonald, Nicolas Martin, Daniel Rosenberg and Maria Solonets are employees of Janssen Pharmaceutical Companies of Johnson & Johnson. Richard Channick served as a Scientific Committee member for Janssen Pharmaceutical Companies of Johnson & Johnson; served on an advisory board for Janssen Pharmaceutical Companies of Johnson & Johnson and Bayer; received research grants/support from Janssen Pharmaceutical Companies of Johnson & Johnson and United Therapeutics; received speaker fees from Janssen Pharmaceutical Companies of Johnson & Johnson, Bayer; and received consultancy fees from Janssen Pharmaceutical Companies of Johnson & Johnson, Bayer and Third Pole.
: OPUS and OrPHeUS were executed in accordance with Good Pharmacoepidemiology Practices and the 2008 Declaration of Helsinki ethical principles. Ethical approval was received from independent ethics committees/institutional review boards of participating centers. The protocols were reviewed by the US FDA with written informed consent obtained from all patients in OPUS including for publication of anonymized patient data (informed consent was not required in OrPHeUS as an IRB waiver was obtained). IRB approvals were provided by the Western IRB and Quorum (now Advarra) (OPUS registry; Western IRB approval number 2014-0816, Quorum Review File number 29120/Advarra Pro00035124) and WCG-IRB (OrPHeUS study; IRB numbers 2017-8051 and 2017-2348).
: Medical writing assistance was provided by Anna Chapman-Barnes PhD and Ioanna Ntai PhD of eluSCIdate Ltd (Meggen, Switzerland). Graphical abstract support was provided by Lauren Main of Ashfield MedComms, an Inizio company. Medical writing support and the development of the graphical abstract were funded by Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson. Clinical evaluation of hepatic safety was performed by the ILSDRB: Willis Maddrey MD (chairperson), Paul Watkins MD, and James Freston, MD.