Table 2

Summary of outcome data for the pooled population

Belimumab plus standard therapyStandard therapyP-value
5-year SDI score change (95% CI) (n=181)*0.265 (0.180 to 0.350)0.718 (0.548 to 0.889)
 Difference (95% CI)–0.453 (–0.646 to 0.260)<0.001
Rate of organ damage progression (n=323)*
 HR vs standard therapy (95% CI)0.397 (0.275 to 0.572)<0.001
 Intercept hazard rate (95% CI)0.078 (0.064 to 0.096)<0.001
 Annual probability of progression3.1%7.5%
Magnitude of year-on-year organ damage progression (n=323)*
 ≥1-point SDI increase events, n (%)41 (12.7)87 (26.9)
 ≥2-point SDI increase events, n (%)2 (0.6)26 (8.0)
 Proportion of ≥2-point SDI increase events/≥1-point SDI increase events, n/n (%)2/41 (4.9)26/87 (29.9)
  • *n values presented are equal for each cohort.

  • †The annual probability of SDI progression was derived using the hazard rate estimates from the proportional-hazards exponential regression model.

  • CI, confidence interval; HR, hazard ratio; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index.