Table 4.
Major improvement and clinically important improvements in ASDAS and improvements in ASAS at first and second follow-up: CT-P13 versus reference infliximab*
| Overall patient population | Year 1 | Year 2 | ||||
|---|---|---|---|---|---|---|
| CT-P13 (n = 64) | Reference infliximab (n = 38) | P value† | CT-P13 (n = 48) | Reference infliximab (n = 31) | p value† | |
| ASAS20a | 46 (71.9) | 28 (73.7) | 0.07 | 36 (75.0) | 23 (74.2) | 0.23 |
| ASAS40b | 34 (53.1) | 21 (55.3) | 0.17 | 28 (58.3) | 15 (48.4) | 0.11 |
| ASDAS improvement criteria | ||||||
| Major improvement | 34 (34.3) | 26 (31.0) | 0.13 | 28 (43.1) | 18 (34.6) | 0.98 |
| Patients receiving first-line treatment | CT-P13 (n = 52) | Reference infliximab (n = 31) | P value† | CT-P13 (n = 39) | Reference infliximab (n = 22) | p value† |
|---|---|---|---|---|---|---|
| ASAS20a | 36 (69.2) | 23 (74.2) | 0.51 | 29 (55.8) | 17 (77.3) | 0.51 |
| ASAS40b | 25 (48.1) | 17 (54.8) | 0.80 | 23 (44.2) | 12 (54.5) | 0.35 |
| ASDAS improvement criteria | ||||||
| Major improvement | 30 (39.0) | 23 (41.1) | 0.13 | 23 (44.2) | 14 (40.0) | 0.72 |
Data presented are n (%)
ASAS Assessment in Ankylosing Spondylitis Response Criteria, ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, GA global assessment
*Significant p value (p < 0.05)
†P value based on Chi-square test
aASAS Response Criteria (ASAS20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0–100 scale in at least three of the following domains: patient GA, pain assessment, function (BASFI), and inflammation (last two questions of BASDAI)
bASAS40 is defined as for ASAS20 above, but with improvements of at least 40%