LSM changes from baseline in PROs at 24 weeks in AMBITION and ADACTA
| AMBITION* | ADACTA* | ||||||
| LSM change from baseline† | LSM change from baseline† | ||||||
| TCZ | MTX | Difference (95% CI) | TCZ | ADA | Difference (95% CI) | p value | |
| PtGA, VAS 0–100 mm | −33.5 | −29.5 | −4.1 (−9.3 to 1.2) | −42.3 | −31.8 | −10.5 (−17.7 to −3.3) | 0.004 |
| Patient pain, VAS 0–100 mm | −31.5 | −29.5 | −2.0 (−7.1 to 3.1) | −40.1 | −28.7 | −11.3 (−18.3 to −4.3) | 0.002 |
| HAQ-DI, 0–3 | −0.7‡ | −0.5 | −0.2 (−0.3 to −0.1) | −0.7 | −0.5 | −0.2 (−0.3 to 0.0) | 0.065 |
| FACIT-Fatigue, 0–52 | 8.7‡ | 5.7 | 2.9 (1.0 to 4.8) | 11.4 | 8.9 | 2.5 (−0.3 to 5.3) | 0.077 |
| SF-36 PCS (mean: 50, SD: 10) | 9.8‡ | 7.8 | 2.0 (0.4 to 3.7) | 9.2 | 7.6 | 1.6 (−0.6 to 3.8) | 0.164 |
| SF-36 MCS (mean: 50, SD: 10) | 6.8 | 4.8 | 2.0 (−0.3 to 4.2) | 7.9 | 5.0 | 2.9 (0.0 to 5.9) | 0.050 |
| SF-36 domains, 0–100 | |||||||
| Physical functioning | 23.0‡ | 16.5 | 6.5 (2.2 to 10.8) | 20.0 | 16.0 | 4.0 (−1.5 to 9.5) | 0.156 |
| Role-physical | 37.3 | 29.8 | 7.5 (−0.1 to 15.2) | 23.8 | 16.4 | 7.4 (1.3 to 13.5) | 0.017 |
| Bodily pain | 30.4‡ | 24.8 | 5.7 (1.9 to 9.5) | 29.3 | 23.8 | 5.5 (−0.2 to 11.2) | 0.058 |
| General health | 12.7 | 9.6 | 3.1 (−0.1 to 6.3) | 10.7 | 7.6 | 3.0 (−1.2 to 7.3) | 0.156 |
| Vitality | 19.5‡ | 12.9 | 6.6 (2.9 to 10.4) | 19.1 | 14.0 | 5.1 (0.2 to 9.9) | 0.040 |
| Social functioning | 21.5‡ | 16.4 | 5.1 (1.0 to 9.3) | 23.4 | 17.1 | 6.3 (0.6 to 12.0) | 0.032 |
| Role-emotional | 28.5 | 22.2 | 6.3 (−1.5 to 14.1) | 15.4 | 9.7 | 5.7 (−0.6 to 12.0) | 0.077 |
| Mental health | 14.3‡ | 10.2 | 4.1 (0.8 to 7.5) | 13.5 | 9.3 | 4.2 (−0.1 to 8.5) | 0.057 |
| CDAI | −25.6§ | −19.8 | −5.8 (−8.6 to −3.0) | −23.8 | −18.9 | −4.9 (−8.3 to −1.5) | 0.005 |
*Analyses were performed using the per-protocol population in AMBITION (TCZ, n=265; MTX, n=259) and the intention-to-treat population in ADACTA (TCZ, n=163; ADA, n=162).
†Adjusted for site (AMBITION)/region (ADACTA), baseline score (ADACTA) and duration of RA.
‡Statistical significance is demonstrated by the lower limit of the 95% CI of TCZ – MTX >0.
§Statistical significance is demonstrated by the upper limit of the 95% CI of TCZ – MTX <0.
ADA, adalimumab; CDAI, Clinical Disease Activity Index; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCS, mental component summary; MTX, methotrexate; PCS, physical component summary; PRO, patient-reported outcome; PtGA, patient global assessment; RA, rheumatoid arthritis; SF-36, Short Form-36; TCZ, tocilizumab; VAS, visual analogue scale.