Table 2

Proportion of patients with AS with an ASAS20 response, ASAS40 response and ASAS PR* (efficacy population in PLANETAS extension study with MEX approach)

VisitEfficacy parameterGroupResponder n/N (%)OR95% CI of ORp Value
Week 14ASAS20Maintenance§58/87 (66.7)1.050.56 to 1.970.966
Switch¶56/86 (65.1)
ASAS40Maintenance40/87 (46.0)0.970.53 to 1.780.842
Switch40/86 (46.5)
ASAS PRMaintenance14/87 (16.1)1.160.49 to 2.710.596
Switch12/86 (14.0)
Week 30ASAS20Maintenance65/88 (73.9)0.850.43 to 1.700.359
Switch66/86 (76.7)
ASAS40Maintenance50/88 (56.8)1.190.65 to 2.180.783
Switch45/86 (52.3)
ASAS PRMaintenance14/88 (15.9)0.950.42 to 2.150.997
Switch14/86 (16.3)
Week 54ASAS20Maintenance62/88 (70.5)0.750.38 to 1.480.455
Switch65/86 (75.6)
ASAS40Maintenance51/88 (58.0)1.200.66 to 2.180.592
Switch46/86 (53.5)
ASAS PRMaintenance15/88 (17.0)1.000.45 to 2.200.915
Switch15/86 (17.4)
Week 78ASAS20Maintenance61/87 (70.1)0.660.33 to 1.320.137
Switch64/83 (77.1)
ASAS40Maintenance50/87 (57.5)1.250.68 to 2.310.080
Switch43/83 (51.8)
ASAS PRMaintenance18/87 (20.7)1.080.51 to 2.310.359
Switch16/83 (19.3)
Week 102ASAS20Maintenance67/83 (80.7)1.250.58 to 2.700.506
Switch60/78 (76.9)
ASAS40Maintenance53/83 (63.9)1.090.57 to 2.070.672
Switch48/78 (61.5)
ASAS PRMaintenance16/83 (19.3)0.800.37 to 1.720.275
Switch18/78 (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.