ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 0497

Efficacy in Patient Subgroups in the INCREASE Trial, a Phase III Trial to Evaluate Inhaled Treprostinil in Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease

Victor Tapson1, Steven Nathan2, Reda Girgis3, James Runo4, Remzi Bag5, Arunabh Talwar6, Peter Smith7, Lisa Edwards7, Christine Park7 and Aaron Waxman8, 1Cedars-Sinai, Los Angeles, CA, 2Inova Fairfax, Falls Church, VA, 3Michigan State University, Lansing, MI, 4University of Wisconsin, Madison, WI, 5University of Chicago, Chicago, IL, 6Hofstra Northwell School of Medicine, Hempstead, NY, 7United Therapeutics Corporation, Durham, NC, 8Brigham and Women's Hospital, Boston, MA

Meeting: ACR Convergence 2021

Keywords: clinical trial, interstitial lung disease, pulmonary, Randomized Trial, Scleroderma

  • Tweet
  • Email
  • Print
Session Information

Date: Saturday, November 6, 2021

Session Title: Abstracts: Systemic Sclerosis & Related Disorders – Clinical (0496–0501)

Session Type: Abstract Session

Session Time: 3:45PM-4:00PM

Background/Purpose: INCREASE was a 16-week trial evaluating the safety and efficacy of inhaled treprostinil (iTRE) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study met its primary efficacy endpoint of change in 6-minute walking distance (6MWD), demonstrated by a 31m improvement from baseline (260m). Secondary endpoints, including change in N-terminal pro b-type natriuretic peptide (NT-proBNP) and time to clinical worsening, were also met. Post-hoc analyses were conducted to investigate clinical endpoints within patient subgroups.

Methods: All 326 patients randomized in INCREASE were included in the present analyses, of which 72 patients (iTre 40, placebo 32) had connective tissue disease as the cause of their underlying lung disease. Patient subgroups were delineated by median values of the following baseline characteristics: PVR (< 5 WU, ≥5WU), PCWP (< 10 mmHg, ≥10 mmHg), mPAP (< 35 mmHg, ≥35 mmHg), DLCO (< 27% predicted, ≥27% predicted), FVC (< 60% predicted, ≥60% predicted) and NT-proBNP (< 504 pg/mL, ≥504 pg/mL). Clinical worsening was defined as any of the following: cardiopulmonary hospitalization, decrease in 6MWD >15% from baseline, all-cause death, or lung transplantation.

Results: 6MWD improvements were demonstrated in all subgroups. Statistically significant improvements occurred in patients with above median PVR, PCWP, mPAP; lower than median DLCO; and in both above median and below median FVC and NT-proBNP cohorts (p≤0.013 for all). Statistically significant reductions in NT-proBNP were demonstrated in all subgroups (p≤0.028 for all). Statistically significant benefit in time to clinical worsening with iTRE was observed in above median PVR, mPAP, and NT-proBNP; and lower PCWP (p≤0.0493 for all). Overall, response separation in clinical endpoints indicated greater improvement for patients with above median NT-proBNP and PVR. A similar trend of benefit was observed in lower DLCO and higher mPAP subgroups.

Conclusion: These analyses demonstrate improvements in clinical endpoints with inhaled treprostinil across patient subgroups. Patients with more advanced pulmonary vascular disease stand to gain the most benefit with inhaled treprostinil therapy.


Disclosures: V. Tapson, Bayer, 1, Janssen / johnson & Johnson, 1, 5, 6, United Therapeutics, 1, 5, 6; S. Nathan, United Therapeutics, 1, 2, 6; R. Girgis, United Therapeutics, 5; J. Runo, None; R. Bag, None; A. Talwar, None; P. Smith, United Therapeutics, 3; L. Edwards, United Therapeutics Corporation, 3, 11; C. Park, United Therapeutics, 3; A. Waxman, United Therapeutics, 1, Acceleron, 1, ARIA CV, 1, Gossamer, 5, INSMED, 1.

To cite this abstract in AMA style:

Tapson V, Nathan S, Girgis R, Runo J, Bag R, Talwar A, Smith P, Edwards L, Park C, Waxman A. Efficacy in Patient Subgroups in the INCREASE Trial, a Phase III Trial to Evaluate Inhaled Treprostinil in Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/efficacy-in-patient-subgroups-in-the-increase-trial-a-phase-iii-trial-to-evaluate-inhaled-treprostinil-in-patients-with-pulmonary-hypertension-due-to-parenchymal-lung-disease/. Accessed January 27, 2023.
  • Tweet
  • Email
  • Print

« Back to ACR Convergence 2021

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-in-patient-subgroups-in-the-increase-trial-a-phase-iii-trial-to-evaluate-inhaled-treprostinil-in-patients-with-pulmonary-hypertension-due-to-parenchymal-lung-disease/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2023 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences