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The real-world use of OPSUMIT® (macitentan) has been rigorously examined in both the OPUS registry and the OrPHeUS cohort study. These data demonstrate the effective use of OPSUMIT® in a broad range of patients with pulmonary arterial hypertension (PAH), including those with PAH associated with connective tissue disease (CTD), as well as in elderly patients with PAH and those with comorbidities.[1][2][3][4][5]

OPUS registry

A prospective, multicentre (US), long-term, observational drug registry developed to characterise the safety profile of OPSUMIT® and describe the clinical characteristics and outcomes of patients newly treated with OPSUMIT® in the post-marketing setting (NCT02126943).[6][7]

Conducted during April 2014–2020, it included patients newly treated with OPSUMIT® regardless of diagnosis and prior/ongoing PAH therapy.[6][7]

OrPHeUS cohort study

A retrospective, multicentre, medical chart review in the US conducted during October 2013–March 2017 was designed to supplement the OPUS registry with retrospectively identified first-time OPSUMIT® users in order to achieve the desired sample size (NCT03197688).[6][7]

The study included patients newly treated with OPSUMIT® not enrolled in the OPUS registry.[6][7]

Patient population

As of October 2018, the OPUS registry included 1,710 patients with follow-up data.[1]

Patient population

Adapted from Channick et al. 2019[1]

OrPHeUS included an additional 2,332 patients with PAH, with the majority being in World Health Organization (WHO) functional class (FC) II (28.7%) and III (59.5%).[8]

Real-world use of OPSUMIT® in patients with CTD-PAH

Real-world data from OPUS and OrPHeUS support the use of OPSUMIT® in patients with connective tissue disease (CTD)-associated pulmonary arterial hypertension (PAH) and its subtypes, including PAH associated with scleroderma/systemic sclerosis (SSc), systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD). Similar clinical outcomes were observed in patients with CTD-PAH and those with idiopathic PAH (IPAH)/heritable PAH (HPAH) at 2 years.[2]

patient survival at 24 months following opsumit initiation

Adapted from McLaughlin et al. 2019[2]

Real-world use of OPSUMIT® in PAH patients with comorbidities

Real-world data from the OPUS registry show that OPSUMIT® can be used effectively in patients with pulmonary arterial hypertension (PAH) and various comorbidities that may complicate treatment choice, including:[3][4]

  • Obesity
  • Diabetes mellitus
  • Hypertension
  • Anaemia*
  • Renal insufficiency

Component not published? componentType is undefined.

Real-world use of OPSUMIT® in elderly patients with PAH

Evidence from the combined OPUS registry and OrPHeUS cohort show that OPSUMIT® can be used effectively in both younger (<65 years) and older (≥65 years) patients with pulmonary arterial hypertension (PAH).*[5]

Component not published? componentType is undefined.

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Safety and tolerability

OPSUMIT® has a well-characterised and generally manageable safety profile.[9][10]

SERAPHIN: Long-term efficacy in PAH

The SERAPHIN trial assessed the long-term efficacy of OPSUMIT® in a broad range of patients with PAH.[10][11]

OPTIMA: Benefits of initial combination therapy

The OPTIMA trial explored the benefits of initial combination therapy with OPSUMIT® and tadalafil in patients with PAH.[12]

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CHD, congenital heart disease; CI, confidence interval; CTD, connective tissue disease; FC, functional class; HPAH, heritable pulmonary arterial hypertension; IPAH, idiopathic pulmonary arterial hypertension; MCTD, mixed connective tissue disease; PAH, pulmonary arterial hypertension; SLE, systemic lupus erythematosus; SSc, systemic sclerosis; WHO, World Health Organization

OPSUMIT® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING

Referenzen

Channick R et al. Presented at International Society for Heart and Lung Transplantation 39th Annual Meeting and Scientific Sessions; 3–6 April 2019; Orlando, FL, USA (Poster no. 1235).
McLaughlin VV et al. Oral presentation at CHEST Annual Meeting; 19–23 October 2019; New Orleans, LA, USA.
McLaughlin VV et al. Presented at International Society for Pharmacoeconomics and Outcomes Research Conference; 19–23 May 2018; Baltimore, MD, USA.
Rajagopal S et al. Presented online at American College of Cardiology Virtual Meeting; 28–30 March 2020 (Poster no. 1255-053).
Chin K et al. Presented at CHEST Annual Meeting; 19–23 October 2019; New Orleans, LA, USA.
McLaughlin VV et al. Chest 2019; 156(4):A874–A876.
Janssen Data on File PAH/DOF/JUL2020/EMEA001, July 2020.
McLaughlin V et al. Presented at European Society of Cardiology Congress; 30 August – 4 September 2019; Paris, France (Poster P3674).
OPSUMIT® SmPC, June 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/opsumit-epar-product-information_en.pdf (last accessed June 2021).
Pulido T et al. N Engl J Med 2013; 369(9):809–818.
Pulido T et al. N Engl J Med 2013; 369(9):809–818 (supplementary appendix).
Sitbon O et al. Eur Respir J 2020; doi: 10.1183/13993003.00673-2020.