Table 2

Final models for adjusted mean SELENA-SLEDAI in the observation period as predictors of death/organ system damage in the follow-up period

Death
(n=1168)
Overall damage*
(n=888)
Renal damage*
(n=1147)
Cardiovascular damage*(n=1135)
Patients with outcome, %7.938.52.76.5
Adjusted mean SELENA-SLEDAI in observation period, adjusted HR
(95% CI)
1.22 (1.13 to 1.32)‡1.09 (1.04 to 1.15)1.24 (1.08 to 1.42)§1.17 (1.07 to 1.29)¶
P value<0.001<0.0010.003<0.001
Variables**, adjusted HR (95% CI)
Age at cohort entry (years)1.05 (1.04 to 1.07)††1.04 (1.03 to 1.05)††1.02 (0.98 to 1.05)1.04 (1.02 to 1.06)††
Men1.53 (0.81 to 2.89)0.94 (0.62 to 1.41)1.97 (0.52 to 7.46)1.86 (0.90 to 3.85)
Non-white1.24 (0.79 to 1.97)1.05 (0.84 to 1.31)2.28 (1.00 to 5.18)1.01 (0.62 to 1.63)
Duration of SLE at cohort entry (years)1.02 (0.99 to 1.05)1.01 (1.00 to 1.03)0.98 (0.92 to 1.04)1.00 (0.96 to 1.04)
SDI score at start of follow-up period1.41 (1.02 to 1.94)††N/A6.77 (4.32 to 10.61)††2.40 (1.78 to 3.23)††
Oral prednisone use in observation period
 NoneRefRefRefRef
 ≤7.5 mg/day1.47 (0.77 to 2.80)1.29 (0.97 to 1.71)0.98 (0.28 to 3.45)0.98 (0.50 to 1.94)
 >7.5 mg/day1.54 (0.88 to 2.71)1.85 (1.40 to 2.44)††0.82 (0.32 to 2.10)1.05 (0.56 to 1.95)
HCQ ever use in observation period0.46 (0.29 to 0.72)††NS0.30 (0.13 to 0.68)††NS
Current smoker at cohort entry1.74 (1.09 to 2.76)††NSNSNS
NSAIDs use in observation periodNSNSNS1.66 (1.04 to 2.63)††
  • *In patients without a prior history of damage in the organ system of interest at the start of the follow-up period.

  • †HR for a one-unit increase in adjusted mean SELENA-SLEDAI during the observation periods. Models are adjusted for age at cohort entry (years), gender, non-white, duration of SLE at cohort entry (years), damage accrued (SDI score) in any other organ system but the outcome of interest through the end of the observation period (excluding the outcome of overall damage in any organ system), oral prednisone use in observation period (>7.5 mg/day).

  • ‡Additional model adjustments include ever use of hydroxychloroquine during the observation period and current smoker at cohort entry.

  • §Additional model adjustments include ever use of hydroxychloroquine during the observation period.

  • ¶Additional model adjustments include NSAID use during the observation period.

  • **SLE therapies defined as ever use during observation period.

  • ††P<0.05.

  • CI, confidence interval; HCQ, hydroxychloroquine; HR, Cox proportional hazards ratio; NS, not a statistically significant predictor in the final Cox model; NSAID, non-steroidal anti-inflammatory drug; Ref, reference group; SDI, SLICC/ACR damage index; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index; SLE, systemic lupus erythematosus.