Rheumatoid arthritis

Effect of using the Simple Erosion Narrowing Score or Sharp/van der Heijde score on the power of rheumatoid arthritis clinical trials to detect differences in radiographic progression

Rheumatology (Oxford)Published Secondary analysis of the DRESS and BeSt clinical trials

Authors' conclusion

SENS appears to be a reasonable alternative to SHS, with only a limited loss of power to show between-group differences in radiographic progression.

Study context

Population
Data from two clinical trials in RA (DRESS and BeSt)2 trials
Comparison
Simple Erosion Narrowing Score (SENS) vs SHS for power to show between-group differences in radiographic progression
Primary endpoint
Power to show a between-group difference in radiographic progression (number of bootstrap replications with a significant difference)
Methodological detailsmethodological study, bootstrapping (10 000 replications of each study), analysis of covariance adjusted for baseline scores
  • Methodological study
  • Bootstrapping (10 000 replications of each study)
  • Analysis of covariance adjusted for baseline scores

Primary result

As reported in the abstract

Loss in power of SENS vs SHS
  • Loss in power of SENS over SHS limited to at most 19% (BeSt year 5)
  • Difference in power between SENS and SHS smaller at higher levels of power

Further findings

Criterion validity: Spearman correlation SENS vs SHS

All correlations
>0.9
DRESS change score at 18 months
0.787

Original publication

Effect of using the Simple Erosion Narrowing Score or Sharp/van der Heijde score on the power of rheumatoid arthritis clinical trials to detect differences in radiographic progression. Rheumatology (Oxford). Published 12 June 2024. doi:10.1093/rheumatology/keae328

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