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Table 2 Mean changes in PRO measures from baseline to week 24 of the ATLAS study

From: Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis

PRO measure Placebo (n = 107) Adalimumab (n = 208) Overall F valuea P valuec
BASDAI, 0–10 cm -1.0 ± 0.23 -2.8 ± 0.17 30.30b < 0.001
BASFI, 0–10 cm -0.5 ± 0.19 -2.0 ± 0.14 23.14b < 0.001
SF-36 PCS, 0–50 2.1 ± 0.84 7.3 ± 0.59 24.56b < 0.001
SF-36 MCS, 0–50 2.1 ± 0.95 3.7 ± 0.67 42.05b 0.181
   Physical Function 4.1 ± 2.00 13.3 ± 1.42 19.32b < 0.001
   Role–Physical 10.0 ± 3.51 27.5 ± 2.51 23.00b < 0.001
   Bodily Pain 7.0 ± 2.03 20.7 ± 1.45 24.39b < 0.001
   General Health 1.5 ± 1.55 8.7 ± 1.11 21.89b < 0.001
   Vitality 5.8 ± 1.86 14.6 ± 1.33 21.33b < 0.001
   Social Function 5.0 ± 2.11 12.6 ± 1.51 34.86b 0.003
   Role–Emotional 5.0 ± 3.55 15.6 ± 2.51 77.42b 0.015
   Mental Health 4.8 ± 1.54 5.9 ± 1.11 30.43b 0.551
ASQOL, 0–18 -1.1 ± 0.40 -3.5 ± 0.28 17.28b < 0.001
  1. Data are least-square mean ± standard error.
  2. aANCOVA model controlling for baseline score of patient was performed.
  3. bP < 0.001 based on ANCOVA.
  4. cP-values based on paired Student t-tests for comparison of means between placebo-treated and adalimumab-treated patients.
  5. ANCOVA = analysis of covariance; ASQOL = AS Quality of Life Questionnaire; ATLAS = Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS; BASDAI = Bath AS Disease Activity Index; BASFI = Bath AS Functional Index; MCS = Mental Component Summary; PCS = Physical Component Summary; PRO = patient-reported outcome; SF-36 = Short Form-36 Health Survey.