Change from baseline in patient-reported outcomes at weeks 12 and 24
| Least square mean change ± SE (n) | ||||||
|---|---|---|---|---|---|---|
| Week 12 | Week 24 | |||||
| Patient-reported outcome | Placebo+csDMARDs (n=181) | Sarilumab 150 mg q2w+csDMARDs (n=181) | Sarilumab 200 mg q2w+csDMARDs (n=184) | Placebo+csDMARDs (n=181) | Sarilumab 150 mg q2w+csDMARDs (n=181) | Sarilumab 200 mg q2w+csDMARDs (n=184) |
| PtGA | −13.8±1.8 (172) | −25.3±1.8 (165)* | −27.4±1.8 (171)* | −19.8±2.2 (100) | −29.6±2.1 (127)† | −31.3±2.0 (136)* |
| Pain VAS | −15.1±1.9 (171) | −26.9±1.9 (166)* | −30.6±1.9 (171)* | −21.3±2.3 (98) | −31.9±2.1 (127)† | −33.7±2.0 (135)* |
| HAQ-DI | −0.26±0.04 (170) | −0.46±0.04 (165)†§ | −0.47±0.04 (171)†§ | −0.34±0.05 (101) | −0.52±0.05 (127)‡§ | −0.58±0.05 (136)‡§ |
| FACIT-F | 5.6±0.7 (169) | 8.0±0.7 (165)‡ | 9.5±0.7 (172)* | 6.8±0.9 (98) | 9.9±0.8 (126)‡ | 10.1±0.8 (136)‡ |
| Morning stiffness | −13.4±2.1 (171) | −27.3±2.1 (165)* | −29.4±2.1 (172)* | −21.7±2.4 (101) | −32.3±2.2 (127)† | −33.8±2.1 (136)* |
| RAID | −1.3±0.2 (167) | −2.3±0.2 (162)* | −2.5±0.2 (171)* | −1.8±0.2 (99) | −2.6±0.2 (126)‡ | −2.8±0.2 (136)† |
| SF-36 summary scores | ||||||
| PCS | 3.7±0.6 (169) | 6.9±0.6 (160)* | 6.8±0.6 (165)* | 4.4±0.7 (99) | 7.7±0.7 (123)†§ | 8.5±0.6 (134)*§ |
| MCS | 3.5±0.7 (169) | 5.1±0.8 (160) | 6.5±0.7 (165)‡ | 4.7±0.9 (99) | 6.3±0.8 (123) | 6.8±0.8 (134) |
| SF-36 domains | ||||||
| Physical functioning | 6.7±1.7 (170) | 14.7±1.7 (165)† | 14.7±1.7 (171)† | 8.5±2.0 (99) | 16.1±1.9 (126)‡§ | 16.8±1.8 (135)‡§ |
| Role physical | 10.3±1.7 (170) | 16.8±1.7 (162)‡ | 16.3±1.7 (169)‡ | 10.8±2.0 (99) | 17.9±1.9 (126)‡§ | 19.9±1.8 (135)†§ |
| Bodily pain | 11.6±1.5 (170) | 22.0±1.6 (164)* | 24.3±1.5 (170)* | 16.8±1.9 (99) | 24.3±1.8 (127)‡§ | 27.7±1.7 (135)*§ |
| General health | 6.4±1.3 (170) | 8.8±1.3 (164) | 10.9±1.3 (169)‡ | 8.3±1.5 (99) | 11.9±1.4 (127) | 14.8±1.4 (135)‡§ |
| Vitality | 8.5±1.4 (170) | 13.1±1.5 (165)‡ | 15.1±1.4 (171)† | 9.2±1.7 (99) | 14.5±1.6 (127)‡§ | 16.6±1.5 (135)†§ |
| Social functioning | 9.1±1.7 (170) | 17.2±1.7 (165)† | 16.2±1.7 (171)‡ | 12.9±2.1 (99) | 19.3±2.0 (127)‡§ | 19.6±1.9 (135)‡§ |
| Role emotional | 8.2±1.9 (169) | 12.6±1.9 (161) | 13.6±1.9 (168)‡ | 10.5±2.2 (99) | 14.3±2.0 (124) | 15.0±2.0 (135) |
| Mental health | 5.3±1.3 (170) | 7.8±1.3 (165) | 12.1±1.3 (171)* | 8.0±1.6 (99) | 10.8±1.5 (127) | 12.7±1.4 (135)‡§ |
For continuous endpoints, in the primary analysis, data collected after treatment discontinuation or rescue were set to missing, hence the N values quoted for change from baseline analyses were lower than the total N for each treatment group.
*p≤0.0001, †p<0.001 and ‡p<0.05 vs placebo+csDMARDs.
§Statistically significant; all other p values are nominal.
csDMARDs, conventional synthetic disease-modifying anti-rheumatic drugs; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue scale; HAQ-DI, Health Assessment Questionnaire Disability Index; MCS, mental component summary; PCS, physical component summary; PtGA, patient global assessment of disease activity; q2w, every 2 weeks; RAID, Rheumatoid Arthritis Impact of Disease; SF-36, Short Form 36 Health Survey V.2; VAS, visual analogue scale.