Results for secondary efficacy outcome: estimate of least-squares mean change in outcomes from baseline to 6 or 26 weeks
| Outcome | Adalimumab | Placebo | Difference* (95% CI) | p Value |
|---|---|---|---|---|
| Pain score (VAS; 0–100 mm) | ||||
| N | 39 | 37 | ||
| Mean (SD) at baseline | 66.7 (13.1) | 63.6 (12.7) | – | – |
| Mean (SE) change from baseline to W6 (week 6) | −19.3 (4.2) | −16.8 (4.3) | −2.5 (−14.0 to 9.0) | 0.67 |
| Mean (SE) change from baseline to W26 (week 26) | −12.4 (4.2) | −11.0 (4.3) | −1.4 (−13.0 to 10.1) | 0.80 |
| Morning stiffness (minutes) | ||||
| N | 38 | 37 | ||
| Mean at baseline (SD) | 44.0 (60.6) | 34.9 (40.1) | – | – |
| Mean (SE) change from baseline to W6 | −13.1 (6.4) | −16.1 (6.5) | 3.0 (−14.4 to 20.5) | 0.73 |
| Mean (SE) change from baseline to W26 | −13.5 (7.1) | −7.8 (7.4) | −5.8 (−25.6 to 14.1) | 0.56 |
| No of swollen joints (0–30) | ||||
| N | 40 | 37 | ||
| Mean (SD) at baseline | 6.3 (4.6) | 5.7 (4.2) | – | – |
| Mean (SE) change from baseline to W6 | −2.3 (0.4) | −1.6 0.5) | 0.7 (−1.9 to 0.5) | 0.27 |
| Mean (SE) change from baseline to W26 | −3.0 (0.5) | −1.1 (0.5) | −1.9 (−3.2 to −0.6) | 0.0062 |
| No of painful joints (0–30) | ||||
| N | 40 | 37 | ||
| Mean (SD) at baseline | 10.7 (6.3) | 9.5 (6.3) | – | – |
| Mean (SE) change from baseline to W6 | −4.1 (1.0) | −3.7 (1.0) | −0.5 (−3.3 to 2.4) | 0.75 |
| Mean (SE) change from baseline to W26 | −4.2 (1.1) | −2.7 (1.1) | −1.4 (−4.5 to 1.6) | 0.35 |
| No of painful IP joints under digital pressure (0–30) | ||||
| N | 40 | 37 | ||
| Mean (SD) at baseline | 13.1 (5.7) | 13.4 (6.4) | – | – |
| Mean (SE) change from baseline to W6 | −4.1 (1.0) | −3.7 (1.0) | −0.4 (−3.1 to 2.4) | 0.80 |
| Mean (SE) change from baseline to W26 | −3.6 (1.0) | −2.7 (1.1) | −0.9 (3.7 to 2.0) | 0.55 |
| Dreiser Index (0–30) | ||||
| N | 40 | 37 | ||
| Mean (SD) at baseline (SD) | 15.7 (6.7) | 15.5 (6.0) | – | – |
| Mean (SE) change from baseline to W6 | −2.2 (0.9) | −1.9 (0.9) | −0.3 (−2.7 to 2.2) | 0.82 |
| Mean (SE) change from baseline to W26 | −1.3 (1.0) | −1.3 (1.0) | 0.0 (−2.6 to 2.6) | 1.00 |
| CHFS score (0–90) | ||||
| N | 40 | 37 | ||
| Mean (SD) at baseline | 36.5 (21.6) | 35.6 (18.5) | – | – |
| Mean (SE) change from baseline to W6 | −4.0 (2.3) | −3.2 (2.4) | −0.8 (−7.3 to 5.7) | 0.82 |
| Mean (SE) change from baseline to W26 | −0.7 (2.6) | −1.1 (2.7) | 0.5 (−6.9 to 7.8) | 0.90 |
| Physician global assessment (VAS; 0–100 mm) | ||||
| N | 37 | 36 | ||
| Mean (SD) at baseline (SD) | 63.2 (13.1) | 58.9 (12.0) | – | – |
| Mean (SE) change from baseline to W6 | −13.1 (3.8) | −14.9 (3.9) | 5.2 (−8.7 to 12.3) | 0.73 |
| Mean (SE) change from baseline to W26 | −10.4 (4.4) | −9.3 (4.6) | −1.1 (−13.5 to 11.3) | 0.86 |
| Patient global assessment (VAS; 0–100 mm) | ||||
| N | 39 | 37 | ||
| Mean (SD) at baseline (SD) | 66.4 (17.9) | 59.9 (16.4) | – | – |
| Mean (SE) change from baseline to W6 | −22.6 (4.0) | −16.7 (4.1) | −5.9 (−16.9 to 5.1) | 0.29 |
| Mean (SE) change from baseline to W26 | −12.7 (4.2) | −8.8 (4.3) | −3.9 (−15.2 to 7.4) | 0.49 |
Results are from mixed effects model for repeated measurements: model including terms for treatment group, centre, baseline value of the variable, time, and treatment-by-time interaction.
*Adalimumab minus control.
CHFS, Cochin Hand Function Scale; VAS, Visual Analogue Scale; IP, interphalangeal joint.