Table 3.
LSM changes from baseline in PRO scores at 16 weeks in OPTION, 12 weeks in BREVACTA and 24 weeks in SUMMACTA
| OPTION (week 16)* | BREVACTA (week 12)* | SUMMACTA (week 24)* | |||||||
| LSM change from baseline† | LSM change from baseline† | LSM change from baseline† | |||||||
| TCZ-intravenous every 4 weeks | Placebo every 4 weeks | Difference‡ (95% CI) |
TCZ-subcutaneous every 2 weeks | Placebo every 2 weeks | Difference‡ (95% CI) |
TCZ-subcutaneous weekly | TCZ-intravenous every 4 weeks | Difference (95% CI) |
|
| PtGA, VAS 0–100 mm | −28.4 | −12.0 | −16.4 (−21.6 to −11.3) | −23.4 | −11.7 | −11.6 (−15.4 to − 7.9) | −35.0 | −36.0 | 0.9 (−1.9 to 3.8) |
| Pain, VAS 0–100 mm | −27.1 | −10.0 | −17.1 (−22.4 to −11.8) | −18.5 | −8.1 | −10.5 (−14.2 to −6.7) | −29.2 | −31.1 | 1.9 (−0.9 to 4.7) |
| HAQ-DI, 0–3 | −0.5 | −0.2 | −0.4 (−0.5 to −0.2) | −0.4 | −0.2 | −0.2 (−0.3 to −0.1) | −0.6 | −0.6 | 0 (−0.1 to 0) |
| FACIT-Fatigue, 0–52 | 7.2 | 2.3 | 4.9 (2.8 to 7.0) | 6.0 | 3.2 | 2.8 (1.4 to 4.2) | – | – | – |
| SF-36 PCS (mean, 50; SD, 10) | 8.4 | 2.9 | 5.5 (3.7 to 7.3) | 4.9 | 2.3 | 2.6 (1.4 to 3.7) | 8.7 | 8.9 | −0.2 (−1.1 to 0.8) |
| SF-36 MCS (mean, 50; SD, 10) | 5.7 | 1.9 | 3.8 (1.5 to 6.1) | 5.5 | 2.3 | 3.2 (1.7 to 4.7) | 6.4 | 6.5 | −0.1 (−1.3 to 1.0) |
| SF-36 domains, 0–100 | |||||||||
| Physical functioning | 17.0 | 5.1 | 12.0 (7.3 to 16.7) | 8.9 | 2.8 | 6.0 (2.8 to 9.3) | 18.9 | 19.0 | −0.2 (−2.8 to 2.5) |
| Role-physical | 32.3 | 14.5 | 17.8 (9.9 to 25.8) | 14.9 | 7.7 | 7.2 (3.7 to 10.6) | 20.9 | 21.3 | −0.5 (−3.2 to 2.3) |
| Bodily pain | 26.8 | 10.3 | 16.5 (12.5 to 20.6) | 17.8 | 8.6 | 9.2 (6.0 to 12.4) | 25.5 | 27.5 | −1.9 (−4.4 to 0.5) |
| General health | 12.1 | 4.3 | 7.8 (4.5 to 11.1) | 8.5 | 4.2 | 4.3 (1.8 to 6.9) | 13.0 | 13.3 | −0.3 (−2.3 to 1.7) |
| Vitality | 16.0 | 6.1 | 9.9 (6.3 to 13.5) | 12.0 | 5.3 | 6.8 (4.0 to 9.5) | 16.1 | 14.8 | 1.4 (−0.7 to 3.5) |
| Social functioning | 16.8 | 3.1 | 13.7 (9.3 to 18.2) | 11.0 | 4.8 | 6.2 (2.7 to 9.6) | 20.0 | 20.4 | −0.4 (−2.8 to 2.1) |
| Role-emotional | 29.6 | 11.4 | 18.2 (9.6 to 26.8) | 12.2 | 4.6 | 7.6 (3.9 to 11.3) | 15.7 | 16.9 | −1.1 (−4.1 to 1.9) |
| Mental health | 11.3 | 3.8 | 7.5 (4.1 to 10.9) | 9.9 | 4.6 | 5.4 (2.7 to 8.0) | 10.7 | 10.9 | −0.3 (−2.2 to 1.7) |
| CDAI | −21.6 | −9.7 | −11.9 (−15.0 to –8.8) | −18.8 | −13.0 | −5.8 (−8.1 to –3.5) | −24.8 | −25.4 | 0.5 (−0.8 to 1.9) |
*Analyses were performed using the intention-to-treat population in OPTION (TCZ-intravenous, n=205; placebo, n=204), intention-to-treat population in BREVACTA (TCZ-subcutaneous, n=437; placebo, n=219) and per-protocol population in SUMMACTA (TCZ-subcutaneous, n=558; TCZ-intravenous, n=537). The amount of missing data varied by endpoint and ranged from 5% to 25% in OPTION, 3% to 5% in BREVACTA and 7% to 8% in SUMMACTA. No imputation for missing data was applied.
†Adjusted for site in OPTION and region, body weight category and baseline score in BREVACTA and SUMMACTA.
‡P≤0.001 for the difference in LSM change from baseline between the TCZ-intravenous (OPTION) or TCZ-subcutaneous (BREVACTA) group compared with placebo for all PROs.
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; PCS, physical component summary; PRO, patient-reported outcome; PtGA, patient global assessment; SF-36, Short Form-36; TCZ, tocilizumab; VAS, visual analogue scale.