Visit | Efficacy parameter | Group | Responder n/N (%) | OR† | 95% CI of OR | p Value‡ |
---|---|---|---|---|---|---|
Week 14 | ASAS20 | Maintenance§ | 58/87 (66.7) | 1.05 | 0.56 to 1.97 | 0.966 |
Switch¶ | 56/86 (65.1) | |||||
ASAS40 | Maintenance | 40/87 (46.0) | 0.97 | 0.53 to 1.78 | 0.842 | |
Switch | 40/86 (46.5) | |||||
ASAS PR | Maintenance | 14/87 (16.1) | 1.16 | 0.49 to 2.71 | 0.596 | |
Switch | 12/86 (14.0) | |||||
Week 30 | ASAS20 | Maintenance | 65/88 (73.9) | 0.85 | 0.43 to 1.70 | 0.359 |
Switch | 66/86 (76.7) | |||||
ASAS40 | Maintenance | 50/88 (56.8) | 1.19 | 0.65 to 2.18 | 0.783 | |
Switch | 45/86 (52.3) | |||||
ASAS PR | Maintenance | 14/88 (15.9) | 0.95 | 0.42 to 2.15 | 0.997 | |
Switch | 14/86 (16.3) | |||||
Week 54 | ASAS20 | Maintenance | 62/88 (70.5) | 0.75 | 0.38 to 1.48 | 0.455 |
Switch | 65/86 (75.6) | |||||
ASAS40 | Maintenance | 51/88 (58.0) | 1.20 | 0.66 to 2.18 | 0.592 | |
Switch | 46/86 (53.5) | |||||
ASAS PR | Maintenance | 15/88 (17.0) | 1.00 | 0.45 to 2.20 | 0.915 | |
Switch | 15/86 (17.4) | |||||
Week 78 | ASAS20 | Maintenance | 61/87 (70.1) | 0.66 | 0.33 to 1.32 | 0.137 |
Switch | 64/83 (77.1) | |||||
ASAS40 | Maintenance | 50/87 (57.5) | 1.25 | 0.68 to 2.31 | 0.080 | |
Switch | 43/83 (51.8) | |||||
ASAS PR | Maintenance | 18/87 (20.7) | 1.08 | 0.51 to 2.31 | 0.359 | |
Switch | 16/83 (19.3) | |||||
Week 102 | ASAS20 | Maintenance | 67/83 (80.7) | 1.25 | 0.58 to 2.70 | 0.506 |
Switch | 60/78 (76.9) | |||||
ASAS40 | Maintenance | 53/83 (63.9) | 1.09 | 0.57 to 2.07 | 0.672 | |
Switch | 48/78 (61.5) | |||||
ASAS PR | Maintenance | 16/83 (19.3) | 0.80 | 0.37 to 1.72 | 0.275 | |
Switch | 18/78 (23.1) |
*PR was defined as a value of <20 on a 0–100 scale in each of the following four domains: patient global assessment, pain, function and inflammation.
†The OR was estimated using a logistic regression model with treatment as a fixed effect, and region and baseline BASDAI score as covariates. An OR of >1 indicates increased odds in favour of the maintenance group.
‡The p value was calculated using the Hosmer–Lemeshow test for the goodness-of-fit of the logistic regression model. The test is significant at the 5% level.
§Patients treated with CT-P13 during the 54 weeks of the main study and the 48-week extension study.
¶Patients treated with RP during the 54 weeks of the main study and then switched to CT-P13 during the 48-week extension study.
AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society; ASAS20, 20% response according to the ASAS International Working Group criteria for improvement; ASAS40, 40% response according to the ASAS International Working Group criteria for improvement; MEX, missing equals excluded; n, number of patients with response; N, number of patients in group; PR, partial remission; RP, reference product.