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Table 6 Mean change from baseline in FACIT-Fatigue scores by improvement in PGA and BILAG response rate (pooled sample)

From: Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76)

Week Mean change [95% CI] Δa 95% CI p-value
PGA improvement
Week 24 No
(n = 972)
2.1 [1.4, 2.7] −3.9 [−4.7, −3.0] < 0.0001
Yes
(n = 1496)
5.9 [5.4, 6.4]
Week 52 No
(n = 861)
1.9 [1.1, 2.8] −4.0 [−5.0, −3.0] < 0.0001
Yes
(n = 1481)
5.9 [5.4, 6.4]
BILAG response ≥ 50%b
Week 24 No
(n = 835)
2.7 [2.0, 3.4] −2.7 [−3.6, −1.9] < 0.0001
Yes
(n = 1611)
5.4 [4.9, 5.9]
Week 52 No
(n = 838)
3.3 [2.5, 4.1] −2.2 [−3.1, −1.2] < 0.0001
Yes
(n = 1528)
5.5 [4.9, 6.0]
  1. aΔ (difference) calculated as (improvement in PGA – no improvement in PGA) or (BILAG responder < 50% – BILAG responder ≥50%). Analyses to evaluate ability to detect change used data from baseline through Week 24 and from baseline to Week 52 to calculate BILAG response at Week 24 and Week 52, respectively
  2. bBased on a total of 7 and 14 assessments per patient between baseline and Weeks 24 and 52, respectively
  3. BILAG British Isles Lupus Assessment Group, CI confidence interval, FACIT Functional Assessment of Chronic Illness Therapy, PGA Physician’s Global Assessment, W Week