Table 2.
Change from baseline in patient-reported outcome scores at weeks 24 and 52
| Patient-reported outcome | (n) Least square mean ± standard error | |||||
|---|---|---|---|---|---|---|
| Week 24 | Week 52 | |||||
| Placebo + MTX (n = 398) | Sarilumab 150 mg q2w + MTX (n = 400) | Sarilumab 200 mg q2w + MTX (n = 399) | Placebo + MTX (n = 398) | Sarilumab 150 mg q2w + MTX (n = 400) | Sarilumab 200 mg q2w + MTX (n = 399) | |
| PtGA | (253) -15.7 ± 1.4 | (312) -28.3 ± 1.3*** | (319) -32.9 ± 1.3*** | (196) -20.3 ± 1.5 | (272) -31.7 ± 1.4*** | (272) -32.8 ± 1.4*** |
| Pain VAS | (253) -15.4 ± 1.4 | (313) -28.5 ± 1.4*** | (321) -31.8 ± 1.3*** | (196) -19.3 ± 1.6 | (273) -32.7 ± 1.4*** | (272) -33.1 ± 1.4*** |
| HAQ-DI | (253) -0.32 ± 0.03 | (313) -0.56 ± 0.03*** | (316) -0.57 ± 0.03*** | (195) -0.27 ± 0.04 | (272) -0.62 ± 0.03*** | (270) -0.63 ± 0.03*** |
| FACIT-F | (252) 5.8 ± 0.5 | (311) 8.6 ± 0.5*** | (320) 9.2 ± 0.5*** | (195) 6.1 ± 0.5 | (270) 9.1 ± 0.5*** | (271) 9.2 ± 0.5*** |
| SF-36 component scores | ||||||
| PCS | (246) 5.2 ± 0.5 | (299) 8.0 ± 0.5*** | (309) 8.4 ± 0.5*** | (187) 5.6 ± 0.6 | (257) 9.2 ± 0.5*** | (263) 9.1 ± 0.5*** |
| MCS | (246) 3.9 ± 0.6 | (299) 5.7 ± 0.6* | (309) 8.2 ± 0.6*** | (187) 5.5 ± 0.7 | (257) 7.1 ± 0.6 | (263) 8.4 ± 0.6** |
| SF-36 domain scores | ||||||
| Physical functioning | (253) 11.9 ± 1.5 | (312) 17.5 ± 1.3* | (316) 18.2 ± 1.3** | (195) 13.9 ± 1.6 | (272) 21.3 ± 1.4** | (269) 21.3 ± 1.4** |
| Role physical | (252) 12.8 ± 1.4 | (309) 18.7 ± 1.3** | (318) 20.4 ± 1.3*** | (194) 15.5 ± 1.5 | (266) 20.7 ± 1.3* | (271) 22.5 ± 1.3** |
| Body pain | (250) 15.3 ± 1.3 | (312) 25.3 ± 1.2*** | (318) 27.6 ± 1.2*** | (192) 16.7 ± 1.5 | (272) 28.1 ± 1.3*** | (269) 28.0 ± 1.3*** |
| General health | (248) 7.6 ± 1.1 | (307) 12.80 ± 1.0** | (319) 15.2 ± 1.0*** | (191) 10.5 ± 1.3 | (269) 14.5 ± 1.1* | (271) 15.9 ± 1.1** |
| Vitality | (251) 9.8 ± 1.2 | (308) 13.9 ± 1.1* | (320) 18.0 ± 1.0*** | (194) 11.4 ± 1.3 | (268) 17.5 ± 1.1** | (271) 17.7 ± 1.1** |
| Social functioning | (252) 9.8 ± 1.4 | (312) 17.3 ± 1.2*** | (320) 20.8 ± 1.2*** | (195) 11.9 ± 1.6 | (272) 20.4 ± 1.4*** | (271) 20.8 ± 1.4*** |
| Role emotional | (252) 10.3 ± 1.5 | (308) 14.6 ± 1.4* | (318) 17.9 ± 1.4*** | (193) 14.8 ± 1.6 | (264) 17.3 ± 1.4 | (269) 21.4 ± 1.4* |
| Mental health | (251) 7.4 ± 1.1 | (308) 10.4 ± 1.0* | (320) 14.0 ± 1.0*** | (194) 9.8 ± 1.2 | (268) 13.0 ± 1.1* | (271) 14.3 ± 1.1* |
q2w every 2 weeks, FACIT-F functional assessment of chronic illness therapy-fatigue scale, HAQ-DI health assessment questionnaire disability index, SF-36 36-item Short Form Health Survey-Version 2, MCS mental component summary, MTX methotrexate, PCS physical component summary, PtGA patient global assessment of disease activity, VAS visual analog scale. *p < 0.05, **p < 0.001, and ***p < 0.0001 versus placebo + MTX