Change in patient-reported outcomes from baseline to week 26 and week 52 by week 26 CDC components achieved (DE019, PREMIER and OPTIMA)
| Continuous outcomes*† | CDC achievers (A) | Achieved DAS remission (B) | Achieved normal physician function (C) | Achieved non-radiographic progression (D) | Difference (E)=(A)−(B) | Difference (F)=(A)−(C) | Difference (G)=(A)−(D) |
|---|---|---|---|---|---|---|---|
| N=200 | N=380 | N=569 | N=1000 | ||||
| Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | |
| Week 26 | |||||||
| VAS-Pain change, N=1463 | −47.49 (−50.07 to −44.91) | −42.21 (−48.53 to −35.90) | −39.89 (−43.62 to −36.16) | −18.32 (−19.95 to −16.68) | −5.27 (−12.09 to 1.55) | −7.60 (−12.11 to −3.08) | −29.17 (−32.24 to −26.11) |
| 200 | 378 | 568 | 997 | ||||
| FACIT-Fatigue change, N=1452 | 13.65 (12.49 to 14.81) | 10.81 (8.02 to 13.60) | 13.92 (12.27 to 15.56) | 4.42 (3.70 to 5.15) | 2.84 (−0.18 to 5.86) | −0.27 (−2.27 to 1.74) | 9.23 (7.84 to 10.61) |
| 196 | 373 | 563 | 988 | ||||
| SF-36 mental change, N=1086 | 8.08 (6.50 to 9.67) | 8.96 (5.55 to 12.38) | 7.97 (5.94 to 9.99) | 3.54 (2.56 to 4.52) | −0.88 (−4.64 to 2.89) | 0.12 (−2.45 to 2.68) | 4.54 (2.68 to 6.41) |
| 131 | 246 | 420 | 680 | ||||
| SF-36 physical change, N=1086 | 20.36 (19.09 to 21.62) | 13.39 (10.70 to 16.08) | 16.33 (14.73 to 17.93) | 4.81 (4.04 to 5.59) | 6.97 (3.99 to 9.95) | 4.03 (2.01 to 6.05) | 15.55 (14.05 to 17.04) |
| 131 | 246 | 420 | 680 | ||||
| Week 52 | |||||||
| VAS-Pain change, N=1306 | −46.11 (−48.95 to −43.27) | −37.16 (−43.92 to −30.40) | −40.61 (−44.80 to −36.42) | −21.02 (−22.87 to −19.17) | −8.95 (−16.28 to −1.62) | −5.50 (−10.55 to −0.45) | −25.09 (−28.49 to −21.68) |
| 189 | 350 | 516 | 900 | ||||
| FACIT-Fatigue change, N=1326 | 13.27 (12.01 to 14.52) | 10.35 (7.43 to 13.27) | 13.61 (11.82 to 15.40) | 5.42 (4.63 to 6.22) | 2.92 (−0.26 to 6.09) | −0.35 (−2.52 to 1.83) | 7.84 (6.34 to 9.34) |
| 186 | 348 | 521 | 912 | ||||
| SF-36 mental change, N=1001 | 7.28 (5.64 to 8.92) | 8.52 (4.91 to 12.13) | 6.93 (4.80 to 9.06) | 3.95 (2.92 to 4.99) | −1.24 (−5.21 to 2.73) | 0.35 (−2.34 to 3.04) | 3.33 (1.38 to 5.27) |
| 126 | 236 | 393 | 630 | ||||
| SF-36 physical change, N=1001 | 20.01 (18.57 to 21.45) | 13.07 (9.96 to 16.18) | 17.12 (15.29 to 18.96) | 6.42 (5.52 to 7.31) | 6.94 (3.51 to 10.37) | 2.89 (0.57 to 5.20) | 13.59 (11.88 to 15.30) |
| 126 | 236 | 393 | 630 | ||||
Boldface indicates statistical significance at the 0.05 level.
*The adjusted analysis compared the mean change from baseline for each outcome by CDC component achievement using an analysis of covariance model in which the impact of component 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.
CDC, comprehensive disease control; DAS, Disease Activity Score; FACIT, Functional Assessment of Chronic Illness Therapy; SF-36, Short Form 36; VAS, Visual Analogue Scale.