Ghuman, Abeer;
Khanna, Dinesh;
Lin, Celia JF;
Furst, Daniel E;
Raghu, Ganesh;
Martinez, Fernando J;
Zucchetto, Mauro;
... Denton, Christopher P; + view all
(2023)
Prognostic and predictive markers of systemic sclerosis-interstitial lung disease in a clinical trial and long-term observational cohort.
Rheumatology
10.1093/rheumatology/kead234.
(In press).
Preview |
Text
Denton_Prognostic and predictive markers of systemic sclerosis-interstitial lung disease in a clinical trial and long-term observational cohort_AAM2.pdf Download (1MB) | Preview |
Abstract
OBJECTIVES: Explore prognostic and predictive markers of systemic sclerosis-associated interstitial lung disease (SSc-ILD) outcomes in a phase 3 trial (focuSSced) and prognostic markers in a real-world cohort (SMART). METHODS: The focuSSced SSc-ILD subgroup included 68 of 106 placebo-treated and 68 of 104 tocilizumab-treated patients. The SMART cohort included 505 patients with SSc-ILD. Linear mixed-effect models were used to identify factors associated with change in forced vital capacity (FVC). Kaplan-Meier estimation and Cox regression were used for time-to-event analyses. RESULTS: In placebo-treated focuSSced patients, sex was a significant prognostic factor for FVC decline; males had increased risk for absolute decline ≥10% in percent-predicted FVC (ppFVC) and 0.22% faster weekly FVC decline than females (P = 0.0001). FVC was 9.8% lower in patients with C-reactive protein >6 mg/ml versus those with C-reactive protein ≤6 mg/ml (P = 0.0059). Tocilizumab reduced the risk for ≥10% decline in ppFVC in patients who were male, had earlier disease (<2 years duration), had interleukin-6 levels <10 pg/ml, or had anti-topoisomerase antibodies (ATA). In the SMART cohort, prognostic factors for ppFVC <70% were male sex, ATA, and low baseline FVC. Males had 3.3% lower FVC 1 year after disease onset (P < 0.001) and 0.6% faster yearly decline (P = 0.03) than females. CONCLUSION: Prognostic markers in SSc-ILD were similar between focuSSced and SMART. Male sex and inflammatory markers were associated with lower FVC but interleukin-6 ≥ 10 pg/ml was not predictive of response to tocilizumab. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02453256.
| Type: | Article |
|---|---|
| Title: | Prognostic and predictive markers of systemic sclerosis-interstitial lung disease in a clinical trial and long-term observational cohort |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/rheumatology/kead234 |
| Publisher version: | https://doi.org/10.1093/rheumatology/kead234 |
| Language: | English |
| Additional information: | © The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/). |
| Keywords: | Autoantigens and autoantibodies, biological therapies, biomarkers, cytokines and inflammatory mediators, interstitial lung disease, scleroderma and related disorders, systemic sclerosis |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10171050 |
Loading...
Loading...Loading...Loading...Archive Staff Only
 |
View Item |
