Table 2.
Efficacy results (mITT population)
| Sarilumab | ||||
|---|---|---|---|---|
| Placebo to 150 mg q2w + MTX (n = 41 (n = 14 at week 52))a |
Placebo to 200 mg q2w + MTX (n = 40 (n = 15 at week 52))a |
150 mg q2w + MTX (n = 81) |
200 mg q2w + MTX (n = 80) |
|
| Signs and symptoms | ||||
| ACR20 response, n (%) | ||||
| At week 12 | 15 (18.5) | 54 (66.7)*** | 52 (65.0)*** | |
| At week 24 | 12 (14.8) | 55 (67.9)*** | 46 (57.5)*** | |
| At week 52 | 9 (64.3) | 10 (66.7) | 58 (71.6) | 48 (60.0) |
| ACR50 response, n (%) | ||||
| At week 12 | 5 (6.2) | 22 (27.2)*** | 25 (31.3)*** | |
| At week 24 | 8 (9.9) | 35 (43.2)*** | 31 (38.8)*** | |
| At week 52 | 8 (57.1) | 10 (66.7) | 37 (45.7) | 38 (47.5) |
| ACR70 response, n (%) | ||||
| At week 12 | 1 (1.2) | 5 (6.2) | 15 (18.8)*** | |
| At week 24 | 3 (3.7) | 15 (18.5)** | 12 (15.0)* | |
| At week 52 | 4 (28.6) | 3 (20.0) | 29 (35.8) | 22 (27.5) |
| ACR components, mean (SD) change from baseline at week 24 | ||||
| Tender joint count | − 9.1 (10.2) | − 13.4 (9.9) | − 12.4 (11.3) | |
| Swollen joint count | − 7.2 (6.7) | − 10.6 (8.1) | − 9.5 (9.1) | |
| Pain VAS | − 22.9 (27.7) | − 36.5 (23.4) | − 30.2 (23.3) | |
| Physician global VAS | − 26.8 (18.4) | − 41.8 (21.6) | − 43.9 (19.4) | |
| Patient global VAS | − 18.3 (22.6) | − 32.4 (21.0) | − 30.6 (21.9) | |
| HAQ-DI | − 0.3 (0.4) | − 0.5 (0.5) | − 0.6 (0.5) | |
| CRP, mg/l | − 1.7 (12.2) | − 21.1 (19.5) | − 21.3 (18.0) | |
| DAS28-CRP response, mean (SD) change from baseline | ||||
| At week 12 | − 0.8 (1.1) | − 2.3 (1.1)*** | − 2.3 (1.2)*** | |
| At week 24 | − 1.5 (1.2) | − 2.8 (1.0)*** | − 2.8 (1.1)*** | |
| At week 52 | − 3.1 (1.2) | − 2.9 (1.2) | − 3.2 (1.2) | − 3.2 (1.1) |
| DAS28-CRP < 2.6, n (%) | ||||
| At week 12 | 3 (3.7) | 21 (25.9)*** | 27 (33.8)*** | |
| At week 24 | 6 (7.4) | 29 (35.8)*** | 32 (40.0)*** | |
| At week 52 | 7 (50.0) | 9 (60.0) | 41 (50.6) | 43 (53.8) |
| SDAI, mean (SD) change from baseline | ||||
| At week 12 | − 8.9 (12.0) | − 20.7 (11.0)*** | − 18.9 (11.6)*** | |
| At week 24 | − 16.0 (11.6) | − 25.2 (11.6)*** | − 23.8 (11.3)*** | |
| At week 52 | − 29.6 (9.9) | − 23.4 (12.4) | − 29.4 (13.6) | − 26.9 (11.5) |
| SDAI ≤ 3.3, n (%) | ||||
| At week 12 | 0 | 2 (2.5) | 7 (8.8)** | |
| At week 24 | 1 (1.2) | 5 (6.2) | 10 (12.5)** | |
| At week 52 | 2 (14.3) | 1 (6.7) | 19 (23.5) | 18 (22.5) |
| CDAI, mean (SD) change from baseline | ||||
| At week 12 | − 8.7 (11.4) | − 18.8 (10.6)*** | − 16.8 (10.9)*** | |
| At week 24 | − 15.7 (11.1) | − 23.1 (11.2)*** | − 21.7 (10.7)*** | |
| At week 52 | − 28.4 (9.7) | − 21.1 (11.4) | − 27.2 (13.1) | − 24.8 (10.8) |
| CDAI ≤ 2.8, n (%) | ||||
| At week 12 | 0 | 1 (1.2) | 5 (6.3)* | |
| At week 24 | 1 (1.2) | 5 (6.2) | 8 (10.0)* | |
| At week 52 | 1 (7.1) | 0 | 17 (21.0) | 15 (18.8) |
| Physical function | ||||
| HAQ-DI, mean (SD) change from baseline | ||||
| At week 12 | − 0.1 (0.3) | − 0.4 (0.5)*** | − 0.4 (0.5)*** | |
| At week 24 | − 0.3 (0.4) | − 0.5 (0.5)*** | − 0.6 (0.5)*** | |
| At week 52 | − 0.7 (0.6) | − 0.5 (0.3) | − 0.6 (0.6) | − 0.6 (0.6) |
| HAQ-DI response (MCID ≥ 0.3), n (%) | ||||
| At week 12 | 19 (23.5) | 39 (48.1)** | 38 (47.5)** | |
| At week 16 | 19 (23.5) | 37 (45.7)** | 37 (46.3)** | |
| At week 24 | 10 (12.3) | 39 (48.1)*** | 39 (48.8)*** | |
| At week 52 | 9 (64.3) | 8 (53.3) | 46 (56.8) | 43 (53.8) |
*p < 0.05; **p < 0.01; ***p < 0.001
a Data for combined placebo groups (n=81) shown at weeks 12, 16 and 24. ACR American College of Rheumatology, ACR20/50/70 American College of Rheumatology 20%/50%/70% improvement criteria, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score 28-joint count, HAQ-DI Health Assessment Questionnaire-Disability Index, MCID minimum clinically important difference, mITT modified intent-to-treat, MTX methotrexate, q2w every 2 weeks, SDAI Simplified Disease Activity Index, SD standard deviation, SJC swollen joint count, TJC tender joint count, VAS visual analog scale