Systemic sclerosis & Raynaud's
Prognostic and predictive markers of systemic sclerosis-associated interstitial lung disease in a clinical trial and long-term observational cohort
Authors' conclusion
Prognostic markers in SSc-ILD were similar between focuSSced and SMART. Male sex and inflammatory markers were associated with lower FVC but IL-6 ≥10 pg/ml was not predictive of response to tocilizumab.
Study context
- Population
- Patients with SSc-ILD in a phase 3 trial (focuSSced) and a real-world cohort (SMART)
- Participants
- 68 / 68 / 505
- Comparison
- Prognostic and predictive markers of forced vital capacity (FVC) outcomes in SSc-ILD; tocilizumab vs placebo
- Placebon = 68reference
- Tocilizumabn = 68
- SMARTn = 505
- Primary endpoint
- Change in FVC; absolute decline ≥10% in ppFVC
Methodological detailsSMART, linear mixed-effect models, Kaplan-Meier estimation, Cox regression
- SMART
- Linear mixed-effect models
- Kaplan-Meier estimation
- Cox regression
Primary result
As reported in the abstract
Prognostic factors for FVC decline (placebo, focuSSced)
Males vs females: faster weekly FVC decline (males also increased risk of ≥10% absolute percent-predicted FVC (ppFVC) decline)
0.22%
P = 0.0001
FVC lower with CRP >6 mg/ml vs CRP ≤6 mg/ml
9.8%
P = 0.0059
Further findings
SMART cohort prognostic factors
- Males vs females: lower FVC 1 year after disease onset
- 3.3% (P < 0.001)
- Males vs females: faster yearly FVC decline
- 0.6% (P = 0.03)
- Prognostic factors for ppFVC <70%: male sex, anti-topoisomerase antibodies (ATA), low baseline FVC
Original publication
Prognostic and predictive markers of systemic sclerosis-associated interstitial lung disease in a clinical trial and long-term observational cohort. Rheumatology (Oxford). Published 25 May 2023. doi:10.
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