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)

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
	ASAS20	Switch¶	56/86 (65.1)	1.05	0.56 to 1.97
	ASAS40	Maintenance	40/87 (46.0)	0.97	0.53 to 1.78	0.842
	ASAS40	Switch	40/86 (46.5)	0.97	0.53 to 1.78
	ASAS PR	Maintenance	14/87 (16.1)	1.16	0.49 to 2.71	0.596
	ASAS PR	Switch	12/86 (14.0)	1.16	0.49 to 2.71
Week 30	ASAS20	Maintenance	65/88 (73.9)	0.85	0.43 to 1.70	0.359
	ASAS20	Switch	66/86 (76.7)	0.85	0.43 to 1.70
	ASAS40	Maintenance	50/88 (56.8)	1.19	0.65 to 2.18	0.783
	ASAS40	Switch	45/86 (52.3)	1.19	0.65 to 2.18
	ASAS PR	Maintenance	14/88 (15.9)	0.95	0.42 to 2.15	0.997
	ASAS PR	Switch	14/86 (16.3)	0.95	0.42 to 2.15
Week 54	ASAS20	Maintenance	62/88 (70.5)	0.75	0.38 to 1.48	0.455
	ASAS20	Switch	65/86 (75.6)	0.75	0.38 to 1.48
	ASAS40	Maintenance	51/88 (58.0)	1.20	0.66 to 2.18	0.592
	ASAS40	Switch	46/86 (53.5)	1.20	0.66 to 2.18
	ASAS PR	Maintenance	15/88 (17.0)	1.00	0.45 to 2.20	0.915
	ASAS PR	Switch	15/86 (17.4)	1.00	0.45 to 2.20
Week 78	ASAS20	Maintenance	61/87 (70.1)	0.66	0.33 to 1.32	0.137
	ASAS20	Switch	64/83 (77.1)	0.66	0.33 to 1.32
	ASAS40	Maintenance	50/87 (57.5)	1.25	0.68 to 2.31	0.080
	ASAS40	Switch	43/83 (51.8)	1.25	0.68 to 2.31
	ASAS PR	Maintenance	18/87 (20.7)	1.08	0.51 to 2.31	0.359
	ASAS PR	Switch	16/83 (19.3)	1.08	0.51 to 2.31
Week 102	ASAS20	Maintenance	67/83 (80.7)	1.25	0.58 to 2.70	0.506
	ASAS20	Switch	60/78 (76.9)	1.25	0.58 to 2.70
	ASAS40	Maintenance	53/83 (63.9)	1.09	0.57 to 2.07	0.672
	ASAS40	Switch	48/78 (61.5)	1.09	0.57 to 2.07
	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.