Table 1.
Key efficacy outcomes by independent subgroups at screening analyzed at week 16
| Endpoints, % responders (n/M) | Subgroups | Pooled secukinumab 150 mg | Placebo |
|---|---|---|---|
| ASAS40 | CRP+ | 44.5§ (94/211) | 26.7 (28/105) |
| CRP− | 34.8 (55/158) | 29.6 (24/81) | |
| MRI+ | 42.9§ (114/266) | 27.3 (38/139) | |
| MRI− | 34.0 (35/103) | 29.8 (14/47) | |
| HLA-B27+ | 43.9‡ (111/253) | 32.6 (42/129) | |
| HLA-B27− | 32.7‡ (37/113) | 16.4 (9/55) | |
| Male | 51.2§ (84/164) | 30.8 (28/91) | |
| Female | 31.7 (65/205) | 25.3 (24/95) | |
| BASDAI50 | CRP+ | 40.3* (85/211) | 19.0 (20/105) |
| CRP− | 33.5 (53/158) | 23.5 (19/81) | |
| MRI+ | 38.7* (103/266) | 19.4 (27/139) | |
| MRI− | 34.0 (35/103) | 25.5 (12/47) | |
| HLA-B27+ | 41.5† (105/253) | 24.8 (32/129) | |
| HLA-B27− | 29.2§ (33/113) | 10.9 (6/55) | |
| Male | 45.1§ (74/164) | 26.4 (24/91) | |
| Female | 31.2§ (64/205) | 15.8 (15/95) | |
| ASAS PR | CRP+ | 23.7* (50/211) | 6.7 (7/105) |
| CRP− | 18.4§ (29/158) | 7.4 (6/81) | |
| MRI+ | 21.4* (57/266) | 6.5 (9/139) | |
| MRI− | 21.4‡ (22/103) | 8.5 (4/47) | |
| HLA-B27+ | 25.3* (64/253) | 8.5 (11/129) | |
| HLA-B27− | 13.3‡ (15/113) | 3.6 (2/55) | |
| Male | 28.7* (47/164) | 9.9 (9/91) | |
| Female | 15.6† (32/205) | 4.2 (4/95) | |
| ASDAS-CRP ID | CRP+ | 20.9* (44/211) | 3.8 (4/105) |
| CRP− | 21.5 (34/158) | 13.6 (11/81) | |
| MRI+ | 23.7* (63/266) | 8.6 (12/139) | |
| MRI− | 14.6 (15/103) | 6.4 (3/47) | |
| HLA-B27+ | 24.5* (62/253) | 9.3 (12/129) | |
| HLA-B27− | 14.2 (16/113) | 5.5 (3/55) | |
| Male | 29.9* (49/164) | 9.9 (9/91) | |
| Female | 14.1‡ (29/205) | 6.3 (6/95) |
NRI data presented for all variables
ASAS Assessment of SpondyloArthritis international Society, ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, CRP C-reactive protein, HLA human leukocyte antigen, ID inactive disease, M number of evaluable patients, MRI magnetic resonance imaging, NRI non-responder imputation, PR partial remission
*P < 0.0001, †P < 0.001, §P < 0.01, ‡P < 0.05 versus placebo