Show simple item record

Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis

dc.contributor.authorKreuter, Michael
dc.contributor.authorDel Galdo, Francesco
dc.contributor.authorMiede, Corinna
dc.contributor.authorKhanna, Dinesh
dc.contributor.authorWuyts, Wim A.
dc.contributor.authorHummers, Laura K.
dc.contributor.authorAlves, Margarida
dc.contributor.authorSchoof, Nils
dc.contributor.authorStock, Christian
dc.contributor.authorAllanore, Yannick
dc.date.accessioned2022-08-10T18:41:27Z
dc.date.available2022-08-10T18:41:27Z
dc.date.issued2022-01-10
dc.identifier.citationArthritis Research & Therapy. 2022 Jan 10;24(1):19
dc.identifier.urihttps://doi.org/10.1186/s13075-021-02710-9
dc.identifier.urihttps://hdl.handle.net/2027.42/173913en
dc.description.abstractAbstract 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 ClinicalTrials.gov NCT02597933 . Registered on 8 October 2015.
dc.titleImpact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis
dc.typeJournal Article
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/173913/1/13075_2021_Article_2710.pdf
dc.identifier.doihttps://dx.doi.org/10.7302/5644
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.date.updated2022-08-10T18:41:26Z
dc.owningcollnameInterdisciplinary and Peer-Reviewed


Files in this item

Show simple item record

Remediation of Harmful Language

The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.

Accessibility

If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.