Table 2.
Efficacy outcomes following 48 weeks’ of open-label CZP 200 mg Q2W
| Imputation | All axSpA (N = 736) | r-axSpA (n = 407) | nr-axSpA (n = 329) | ||||
|---|---|---|---|---|---|---|---|
| BL | Week 48 | BL | Week 48 | BL | Week 48 | ||
| ASDAS disease states, n (%) | |||||||
| ASDAS-ID | LOCF | 0/736 (0.0) | 385/734 (52.5) | 0/407 (0.0) | 213/407 (52.3) | 0/329 (0.0) | 172/327 (52.6) |
| ASDAS-LD | LOCF | 11/736 (1.5) | 167/734 (22.8) | 6/407 (1.5) | 89/407 (21.9) | 5/329 (1.5) | 78/327 (23.9) |
| ASDAS-HD | LOCF | 293/736 (39.8) | 139/734 (18.9) | 136/407 (33.4) | 79/407 (19.4) | 157/329 (47.7) | 60/327 (18.3) |
| ASDAS-vHD | LOCF | 432/736 (58.7) | 43/734 (5.9) | 265/407 (65.1) | 26/407 (6.4) | 167/329 (50.8) | 17/327 (5.2) |
| ASDAS clinical improvement, n (%) | |||||||
| ASDAS-CII | NRI | – | 564 (76.6) | – | 321 (78.9) | – | 243 (73.9) |
| ASDAS-MI | NRI | – | 413 (56.1) | – | 238 (58.5) | – | 175 (53.2) |
| ASAS responder rates, n (%) | |||||||
| ASAS20 | NRI | – | 586 (79.6) | – | 325 (79.9) | – | 261 (79.3) |
| ASAS40 | NRI | – | 530 (72.0) | – | 290 (71.3) | – | 240 (72.9) |
| ASAS5/6 | NRI | – | 461 (62.6) | – | 281 (69.0) | – | 180 (54.7) |
| ASAS PR | NRI | – | 422 (57.3) | – | 227 (55.8) | – | 195 (59.3) |
| BASDAI50 response, n (%) | NRI | – | 528 (71.7) | – | 290 (71.3) | – | 238 (72.3) |
| ASDAS, mean (SD) | LOCF | 3.7 (0.8) | 1.6 (1.0) | 3.9 (0.8) | 1.6 (1.0) | 3.6 (0.8) | 1.5 (1.0) |
| BASDAI, mean (SD) | LOCF | 6.7 (1.4) | 2.1 (2.4) | 6.7 (1.4) | 2.1 (2.3) | 6.7 (1.4) | 2.2 (2.4) |
| BASFI, mean (SD) | LOCF | 5.3 (2.1) | 1.7 (2.1) | 5.4 (2.0) | 1.7 (2.1) | 5.2 (2.1) | 1.6 (2.1) |
| BASMI, mean (SD) | LOCF | 3.1 (1.5) | 2.3 (1.3) | 3.5 (1.6) | 2.6 (1.4) | 2.6 (1.3) | 1.9 (1.1) |
| ASQoL, mean (SD; n) | OC | 11.1 (4.4; 735) | 2.7 (4.3; 667) | 11.1 (4.4; 407) | 2.7 (4.2; 365) | 11.2 (4.5; 328) | 2.8 (4.5; 302) |
| SF-36 PCS, mean (SD; n) | OC | 34.5 (7.6; 734) | 50.4 (8.0; 667) | 34.8 (7.4; 406) | 50.5 (7.7; 365) | 34.2 (7.7; 328) | 50.3 (8.3; 302) |
| SF-36 MCS, mean (SD; n) | OC | 43.4 (10.7; 734) | 52.6 (9.6; 667) | 43.3 (10.7; 406) | 52.6 (9.4; 365) | 43.6 (10.8; 328) | 52.6 (9.8; 302) |
| MRI outcomes | |||||||
| SIJ SPARCC, mean (SD; n) | OC | 8.0 (11.4; 657) | 1.4 (4.5; 620) | 8.2 (11.8; 358) | 1.4 (4.2; 341) | 7.9 (10.9; 299) | 1.5 (4.8; 279) |
| ASspiMRI-a, mean (SD; n) | OC | 3.1 (5.2; 655) | 0.9 (2.1; 620) | 4.6 (6.1; 357) | 1.2 (2.5; 341) | 1.4 (2.9; 298) | 0.5 (1.3; 279) |
| MASES, mean (SD; n) | OC | 2.5 (3.0; 736) | 0.6 (1.6; 668) | 2.3 (2.8; 407) | 0.5 (1.5; 366) | 2.7 (3.1; 329) | 0.6 (1.7; 302) |
| Tender joint count, mean (SD; n) | OC | 2.6 (5.0; 736) | 0.5 (2.3; 669) | 1.9 (3.8; 407) | 0.3 (1.3; 367) | 3.4 (6.0; 329) | 0.7 (3.0; 302) |
| Swollen joint count, mean (SD; n) | OC | 0.7 (2.1; 736) | 0.1 (0.7; 669) | 0.5 (1.4; 407) | 0.1 (0.4; 367) | 1.1 (2.7; 329) | 0.1 (0.9; 302) |
ASAS Assessment of Spondyloarthritis international Society, ASDAS Ankylosing Spondylitis Disease Activity Score, ASspiMRI-a Ankylosing Spondylitis spine MRI score for activity, BASDAI50 Bath Ankylosing Spondylitis Disease Activity Index 50% improvement, BASFI Bath Ankylosing Spondylitis Functional Index, BASMI Bath Ankylosing Spondylitis Metrology Index, CII clinically important improvement, CZP certolizumab pegol, LS least squares, MASES Maastricht Ankylosing Spondylitis Enthesitis Score, MI major improvement; MMRM mixed effect model for repeated measures, MRI magnetic resonance imaging, NRI non-responder imputation, OC observed case, Q2W every 2 weeks, Q4W every 4 weeks, SD standard deviation, SE standard error, SIJ SPARCC sacroiliac joint Spondyloarthritis Research Consortium of Canada