Effect of mycophenolate mofetil (MMF) on systemic sclerosis-related interstitial lung disease with mildly impaired lung function: a double-blind, placebo-controlled, randomized trial

2019 ◽  
Vol 40 (2) ◽  
pp. 207-216 ◽  
Author(s):  
G. S. R. S. N. K. Naidu ◽  
Shefali Khanna Sharma ◽  
M. B. Adarsh ◽  
Varun Dhir ◽  
Anindita Sinha ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Function ◽  
Lung Disease ◽  
Randomized Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Impaired Lung Function

scholarly journals Impact of Lung Function Decline on Time to Hospitalisation Events in Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD): a Joint Model Analysis

2021 ◽  
Author(s):  
Michael Kreuter ◽  
Francesco Del Galdo ◽  
Corinna Miede ◽  
Dinesh Khanna ◽  
Wim A. Wuyts ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Function ◽  
Lung Disease ◽  
Fold Increase ◽  
Phase Iii ◽  
Lung Function Decline ◽  
Related Hospitalisation ◽  
The Relationship ◽  
Increase In Risk

Abstract Background: Interstitial lung disease (ILD) is a common organ manifestation in systemic sclerosis (SSc) and is the leading cause of death in patients with SSc. A decline in forced vital capacity (FVC) is an indicator of ILD progression and is associated with mortality in patients with SSc-associated ILD (SSc-ILD). However, the relationship between FVC decline and hospitalisation events in patients with SSc-ILD is largely unknown. The objective of this post-hoc analysis was to investigate the relationship between FVC decline and clinically important hospitalisation endpoints.Methods: We used data from SENSCIS®, a Phase III trial investigating the efficacy and safety of nintedanib in patients with SSc-ILD. Joint models for longitudinal and time-to-event data were used to assess the association between rate of decline in FVC% predicted and hospitalisation-related endpoints (including time to first all-cause hospitalisation or death; time to first SSc-related hospitalisation or death; and time to first admission to an emergency room [ER] or admission to hospital followed by admission to intensive care unit [ICU] or death) during the treatment period, over 52 weeks in patients with SSc-ILD.Results: There was a statistically significant association between FVC decline and the risk of all-cause (n=78) and SSc-related (n=42) hospitalisations or death (both P<0.0001). A decrease of 3% in FVC corresponded to a 1.43-fold increase in risk of all-cause hospitalisation or death (95% confidence interval [CI] 1.24, 1.65) and a 1.48-fold increase in risk of SSc-related hospitalisation or death (95% CI 1.23, 1.77). No statistically significant association was observed between FVC decline and admission to ER or to hospital followed by admission to ICU or death (n=75; P=0.15). The estimated slope difference for nintedanib versus placebo in the longitudinal sub-model was consistent with the primary analysis in SENSCIS®.Conclusions: The association of lung function decline with an increased risk of hospitalisation suggests that slowing FVC decline in patients with SSc-ILD may prevent hospitalisations. Our findings also provide evidence that FVC decline may serve as a surrogate endpoint for clinically relevant hospitalisation-associated endpoints.Trial registration: Clinialtrials.gov, NCT02597933. Registered 8 October 2015, https://clinicaltrials.gov/ct2/show/study/NCT02597933.

scholarly journals Mycophenolate Mofetil Versus Placebo for Systemic Sclerosis-Related Interstitial Lung Disease: An Analysis of Scleroderma Lung Studies I and II

2017 ◽  
Vol 69 (7) ◽  
pp. 1451-1460 ◽  
Author(s):  
Elizabeth R. Volkmann ◽  
Donald P. Tashkin ◽  
Ning Li ◽  
Michael D. Roth ◽  
Dinesh Khanna ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Disease

scholarly journals Lung Function and Survival in Systemic Sclerosis Interstitial Lung Disease

2014 ◽  
Vol 41 (11) ◽  
pp. 2326-2328 ◽  
Author(s):  
SAMAR SHADLY AHMED ◽  
SINDHU R. JOHNSON ◽  
CHRISTOPHER MEANEY ◽  
CATHY CHAU ◽  
THEODORE K. MARRAS
Keyword(s):  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Function ◽  
Lung Disease

Mycophenolate mofetil in systemic sclerosis-associated interstitial lung disease

2010 ◽  
Vol 29 (10) ◽  
pp. 1167-1168 ◽  
Author(s):  
Athanasios Koutroumpas ◽  
Athanasios Ziogas ◽  
Ioannis Alexiou ◽  
Georgia Barouta ◽  
Lazaros I. Sakkas
Keyword(s):  
Mycophenolate Mofetil ◽  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Disease
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