According to the aim of this study that tried to get an insight into the impact of RA on the QOL and network of different determinants which can be predictors of better coping with the disease, the instruments of WHOQOL-BREF, SF-36, HAQ-DI
and VAS Pain were used (Table 1).
The secondary outcome measures of mean change in Health Assessment Questionnaire Disability Index (HAQ-DI
), patients global assessment, physician global assessment, and ACR CRISS scores were statistically significant or showed numerical results favoring abatacept over placebo: mean decrease in HAQ-DI
, -0.17 vs.
Outcomes included mean change from baseline in: Health Assessment Questionnaire-Disability Index (HAQ-DI
); Patient Global Assessment of Arthritis (PtGA); Physician Global Assessment of Arthritis (PGA); and Patient Assessment of Arthritis Pain (pain; visual analog scale [VAS]).
The Spearman correlation test was used to evaluate the relationship between the DHI and both BQ and HAQ-DI
for construct validity of the scale.
Functional disability (HAQ-DI
) was not included in the multivariate regression but was significantly associated with employment status and work ability in the univariate analysis.
of patients improved significantly from 1.7 [+ or -] 0.5 of the baseline to 1.2 [+ or -] 0.6, 0.8 [+ or -] 0.4, and 0.7 [+ or -] 0.5 after 12, 24, and 52 weeks of treatment, respectively (p < 0.001).
Additionally, continuous variables ACR-N, HAQ-DI
and DAS-28 were evaluated in a pre-specified manner since the use of endpoints sensitive to change provide better discriminatory power for dose-response assessment, in line with the FDA Guidance For Industry Rheumatoid Arthritis: Developing Drug Products For Treatment, May 2013.
is the most widely used tool for functional assessment in RA.
Variables RA (n = 315) CS (n = 315) Demographic and clinic characteristics Age (years) (a) 48 (18-82) 36 (18-74) Sex% (n) (b) Males 7(23) 40 (127) Females 93 (292) 60 (188) Smokers (b) 29 (71) 9 (29) Disease status Duration of disease (years) (a) 10 (0.1-52) -- DAS28 (c) 4.8 [+ or -] 1.4 -- Spanish HAQ-DI
scorea 0.76 (0-2.28) -- Autoantibodies Rheumatoid factor (IU/mL) (a) 178 (15-717) 15 (0-62) Negative (<20 UI/mL) (b) 16 (50) 95 (300) Low positive (20-59.9 UI/mL) (b) 21 (65) 5(15) High positive (>60 UI/mL) (b) 63 (200) 0(0) Anti-CCP (U/mL) (a) 119 (2-460) 1.5 (0.9-2.5) Negative (<5 U/mL) (b) 17 (52) 100 (315) Low positive (5.1-14.9 U/mL) (b) 9 (27) 0(0) High positive (>15 U/mL) (b) 74 (236) 0(0) (a) Data presented in median (p25-p75).
To examine physical function, the Health Assessment Questionnaire-Disability Index (HAQ-DI
) was used.
It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI
) in analyses that excluded patients with Crohn's disease (because they were not asked about disease severity).
The primary endpoints were ACR20, HAQ-DI
scores and achievement of remission (DAS28 < 2.6) at month 3.