Survival analysis from the INCREASE study in PH-ILD: evaluating the impact of treatment crossover on overall mortality

• DOI: 10.1136/thorax-2023-220821
• Publication Date: 2023-11-18T18:20:58Z
• Authors: Steven D Nathan; Shilpa Johri; Joanna M Joly; Christopher S King; Amresh Raina; Colleen A McEvoy; Dasom Lee; Eric Shen; Peter Smith; Chunqin Deng; Aaron B Waxman
• Keywords: Treprostinil; Post-hoc analysis; Censoring (clinical trials)

Objective A post-hoc analysis of the INCREASE trial and its open-label extension (OLE) was performed to evaluate whether inhaled treprostinil has a long-term survival benefit in patients with pulmonary hypertension associated interstitial lung disease (PH-ILD). Methods Two different models were employed; inverse probability censoring weighting (IPCW) rank-preserving structural failure time (RPSFT) both allow construction pseudo-placebo group, thereby allowing for evaluation PH-ILD receiving treprostinil. Time-varying stabilised weights calculated by fitting Cox proportional hazards based on baseline time-varying prognostic factors generate weighted regression adjusted HRs. Results In trial, there 10 12 deaths placebo arms, respectively, during 16-week randomised trial. During OLE, all received 29 33 prior arm arm, respectively. With conventional analysis, HR death 0.71 (95% CI 0.46 1.10; p=0.1227). Both demonstrated significant reductions treatment HRs 0.62 0.39 0.99; p=0.0483) 0.26 0.07 0.98; p=0.0473) IPCW RPSFT methods, Conclusion independent modelling techniques that have been employed oncology literature suggest PH-ILD.