Secondary efficacy endpoints at week 12—ITT population
| Sarilumab | ||||||
|---|---|---|---|---|---|---|
| Placebo (n=50) | 100 mg q2w (n=49) | 150 mg q2w (n=50) | 100 mg qw (n=52) | 200 mg q2w (n=50) | 150 mg qw (n=50) | |
| Incidence of key secondary efficacy endpoint—responders | ||||||
| ASAS40, n (%) | 4 (8.0) | 7 (14.3) | 8 (16.0) | 3 (5.8) | 9 (18.0) | 10 (20.0) |
| ASAS partial remission, n (%) | 1 (2.0) | 4 (8.2) | 1 (2.0) | 1 (1.9) | 1 (2.0) | 4 (8.0) |
| ASAS5/6 response, n (%) | 3 (6.0) | 6 (12.2) | 5 (10.0) | 7 (13.5) | 7 (14.0) | 16 (32.0)* |
| Change from baseline in key secondary efficacy components | ||||||
| ASAS individual core component change, mean (SD) (0–10 scale) | ||||||
| Back pain | −0.8 (1.8) | −1.3 (2.2) | −1.2 (2.4) | −0.5 (1.8) | −0.9 (2.2) | −1.6 (2.1) |
| Physical function | −0.6 (1.2) | −0.5 (1.7) | −0.4 (2.0) | −0.1 (1.4) | −0.6 (1.9) | −1.1 (1.9) |
| Patient global assessment | −1.0 (1.9) | −1.1 (2.3) | −0.8 (2.3) | −0.4 (2.2) | −0.9 (2.2) | −1.6 (2.0) |
| Inflammation | −1.4 (1.8) | −0.8 (2.0) | −1.1 (2.0) | −0.7 (2.1) | −1.0 (1.9) | −1.8 (2.3) |
| ASspiMRI total score change, mean (SD) | −0.5 (2.2) | −0.5 (1.8) | −0.1 (3.4) | 0.1 (2.4) | −0.3 (3.3) | 0.3 (3.3) |
| ASDAS score change, mean (SD) | −0.4 (0.7) | −0.5 (0.9) | −0.8 (1.2) | −1.1 (0.8) | −1.2 (0.9) | −1.6 (0.9) |
| BASDAI score change, mean (SD) | −0.9 (1.7) | −0.8 (1.9) | −1.1 (2.0) | −0.4 (1.4) | −0.9 (1.8) | −1.2 (1.8) |
| BASMI score change, mean (SD) | −0.2 (0.8) | −0.2 (0.9) | −0.2 (0.8) | −0.4 (0.9) | −0.1 (0.8) | −0.2 (0.7) |
| hs-CRP (mg/dl) change, mean (SD) | −3.7 (19.1) | −1.2 (17.9) | −5.8 (27.6) | −13.5 (20.3)** | −11.5 (17.5)*** | −14.3 (15.3)*** |
| Chest expansion (cm) change, mean (SD) | 0.2 (1.0) | 0.2 (1.2) | 0.0 (1.2) | −0.1 (0.9) | 0.1 (1.3) | 0.3 (1.3) |
n = number of patients with assessment at baseline and week 12. Percentages calculated using the number of ITT patients in the corresponding treatment group as denominator.
*p<0.01; **p<0.001; ***p<0.001, each versus placebo.
‘Inflammation’ represents mean of intensity and duration of morning stiffness from BASDAI.
ASAS, Axial SpondyloArthritis International Society response criteria; ASDAS, AS Disease Activity Score; ASspiMRI, AS spine MRI-active score; BASDAI, Bath AS Disease Activity Index; BASMI, Bath AS Metrology Index; hs-CRP, high-sensitivity C-reactive protein; ITT, intent-to-treat.