Change in patient-reported outcomes from baseline to week 26 and week 52 by week 26 CDC/ACR-EULAR remission achievement (DE019, PREMIER and OPTIMA)
| CDC achievers (A) | ACR-EULAR remission but not CDC (B) | Neither ACR-EULAR remission nor CDC (C) | Difference (D)=(A)−(B) | ||
|---|---|---|---|---|---|
| N=200 | N=29 | N=1226 | |||
| Continuous outcomes*† | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p Value |
| Week 26 | |||||
| VAS-Pain change, N=1451 | −47.07 (−49.96 to −44.19) | −51.59 (−59.12 to −44.05) | −26.45 (−27.61 to −25.29) | 4.51 (−3.55 to 12.57) | 0.2722 |
| 200 | 29 | 1222 | |||
| FACIT-Fatigue change, N=1440 | 13.31 (12.06 to 14.56) | 12.82 (9.62 to 16.01) | 7.42 (6.92 to 7.91) | 0.50 (−2.93 to 3.92) | 0.7764 |
| 196 | 29 | 1215 | |||
| SF-36 mental change, N=1085 | 8.06 (6.46 to 9.67) | 6.05 (2.52 to 9.57) | 4.95 (4.35 to 5.55) | 2.02 (−1.85 to 5.89) | 0.3065 |
| 131 | 27 | 927 | |||
| SF-36 physical change, N=1085 | 19.69 (18.19 to 21.20) | 19.17 (15.91 to 22.44) | 8.59 (8.03 to 9.15) | 0.52 (−3.07 to 4.11) | 0.7754 |
| 131 | 27 | 927 | |||
| Week 52 | |||||
| VAS-Pain change, N=1294 | −45.84 (−48.87 to −42.80) | −51.22 (−59.36 to −43.09) | −28.52 (−29.79 to −27.26) | 5.39 (−3.29 to 14.07) | 0.2234 |
| 189 | 26 | 1079 | |||
| FACIT-Fatigue change, N=1314 | 13.00 (11.69 to 14.31) | 14.16 (10.64 to 17.68) | 7.97 (7.44 to 8.50) | −1.16 (−4.90 to 2.59) | 0.5441 |
| 186 | 25 | 1103 | |||
| SF-36 mental change, N=1000 | 7.27 (5.62 to 8.93) | 8.19 (4.48 to 11.89) | 5.03 (4.39 to 5.66) | −0.91 (−4.97 to 3.14) | 0.6580 |
| 126 | 25 | 849 | |||
| SF-36 physical change, N=1000 | 19.38 (17.77 to 21.00) | 20.54 (16.97 to 24.11) | 9.72 (9.11 to 10.34) | −1.16 (−5.08 to 2.76) | 0.5626 |
| 126 | 25 | 849 | |||
*The adjusted analysis compared the mean change from baseline for each outcome by CDC/ACR-EULAR achievement using an analysis of covariance model in which the impact of achievement on change in the outcome was estimated adjusting for the baseline value of the outcome.
†For VAS-Pain, negative change from baseline indicates an improvement in the outcome. For FACIT-Fatigue, SF-36 Mental Health and SF-36 Physical Health, positive change from baseline indicates an improvement in the outcome.
ACR-EULAR, American College of Rheumatology-European League Against Rheumatism; CDC, comprehensive disease control; FACIT, Functional Assessment of Chronic Illness Therapy; SF-36, Short Form 36; VAS, Visual Analogue Scale.