Systemic sclerosis & Raynaud's

Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease

Rheumatology (Oxford)Published Post-hoc analysis of the SENSCIS randomised trial

Authors' conclusion

Severe SSc-ILD and major deteriorations in lung function have important impacts on HRQoL.

Study context

Population
Patients with SSc-ILD in the SENSCIS trial (nintedanib or placebo, arms aggregated)
Comparison
Forced vital capacity (FVC) <70% predicted vs FVC ≥70% predicted
Primary endpoint
Associations of PRO measures (SGRQ, FACIT-Dyspnoea, HAQ-Disability Index (HAQ-DI) incl. SHAQ VAS) with SSc-ILD severity
Follow-up
Baseline and week 52
Methodological detailstreatment arms aggregated
  • Treatment arms aggregated

Primary result

As reported in the abstract

SGRQ score · week 52

FVC <70% predicted

45.1

FVC ≥70% predicted

34.0

P < 0.0001

Further findings

OutcomeFVC <70% predictedFVC ≥70% predictedP value
FACIT-Dyspnoea score · week 5248.944.5P < 0.0001
HAQ-DI score · week 520.70.6P < 0.0228
SHAQ VAS breathing problems · week 523.62.6P < 0.0001

dcSSc and other SSc-ILD severity characteristics

Worse patient-reported outcome (PRO) scores with dcSSc and other characteristics of SSc-ILD severity

Oxygen requirement or >30% fibrosis on HRCT at baseline · week 52

Worse PRO scores at week 52

Major (>10%) improvement/worsening in FVC and PRO change · 1 year

Corresponding improvement/worsening in SGRQ and other PROs; significant for SGRQ symptom domain
P < 0.001

Original publication

Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). Published 31 May 2022. doi:10.1093/rheumatology/keac325

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