MEDICAL THERAPY FOR CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION- AN INDIRECT TREATMENT COMPARISON OF MACITENTAN AND RIOCIGUAT
Author(s)
Di Scala L1, Howard LS2, Jing ZC3, Lin X4, Mayer E5, Jenkins DP6, Kim NH7
1Actelion Pharmaceuticals Ltd, Allschwil, Switzerland, 2National Pulmonary Hypertension Service, Hammersmith Hospital, London, UK, 3Chinese Academy of Medical Sciences FuWai Hospital and Key Lab of Pulmonary Vascular Medicine, Beijing, China, 4Janssen Research & Development LLC, Spring House, PA, USA, 5Kerckhoff-Klinik, Bad Nauheim, Germany, 6Department of Cardiothoracic Surgery, Royal Papworth Hospital, Cambridge, UK, 7University of California, San Diego, La Jolla, CA, USA
Presentation Documents
OBJECTIVES: Based on CHEST-1, riociguat was the first medical therapy approved for inoperable and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH)1. In MERIT‑1, macitentan improved 6-minute walk distance (6MWD) and reduced pulmonary vascular resistance (PVR) in inoperable CTEPH patients, including patients receiving phosphodiesterase type-5 inhibitors2. This analysis compares the efficacy and safety of macitentan vs riociguat in CTEPH patients. METHODS: An intention-to-treat analysis was performed using matching-adjusted indirect comparison (MAIC)3. MERIT-1 individual patient data (IPD) were re-weighted to match published baseline characteristics (sex, WHO Functional Class, age, BMI, 6MWD, and PVR) of inoperable CHEST-1 patients. Least-squares mean difference and 95% confidence intervals (CI) were calculated to compare the treatment effects of macitentan vs placebo on 6MWD and PVR (recalculated using re-weighted MERIT-1 IPD) with the treatment effects of riociguat vs placebo published for the inoperable patient population of CHEST-1. Safety analysis matched the MERIT-1 population to the overall CHEST-1 population. RESULTS: After matching the MERIT-1 population to the inoperable CHEST-1 population, the difference in treatment effect for macitentan vs riociguat was -13.7m (95% CI -58.2, 30.8) for change in 6MWD and 114.9 dyn.s/cm5 (95% CI ‑25.4, 255.2) for change in PVR. Analyses on MERIT-1 patients without background therapy resulted in differences of ‑0.1m (95% CI -82.5, 82.3) and 120.3 dyn.s/cm5 (95% CI -82.7, 323.3) for change in 6MWD and PVR, respectively. Estimated odds ratios for macitentan vs riociguat were 0.78 (95% CI 0.19, 3.16) for the risk of any adverse event (AE), 0.53 (95% CI 0.10, 2.90) for serious AEs, and 0.68 (95% CI 0.40, 1.16) for exposure-adjusted AEs. CONCLUSIONS: MAIC of MERIT-1 and CHEST-1 showed comparable efficacy and safety for macitentan and riociguat in inoperable CTEPH.
- Ghofrani et al. N Engl J Med 2013;369:319-29.
- Ghofrani et al. Lancet Respir Med 2017;5:785-94.
- Signorovitch et al. Pharmacoeconomics 2010:28:935-45.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PRO2
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Cardiovascular Disorders, Drugs, Rare and Orphan Diseases, Respiratory-Related Disorders