A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis

Table 2 Summary of DAS28-ESR, HAQ, and EULAR response measures

Variable		Week	CinnoRA®	Humira®	P value
DAS28-ESR		12	2.95 ± 1.30	2.96 ± 1.41	0.97*
DAS28-ESR		24	2.58 ± 1.06	2.55 ± 1.14	0.88*
HAQ		12	0.25 (0.88)	0.38 (0.88)	0.87**
HAQ		24	0.25 (0.63)	0.19 (0.63)	0.48**
EULAR response (PP)	No response, n (%)	12	2 (3.03)	7 (10.61)	0.28***
	Moderate response, n (%)		28 (42.42)	25 (37.88)
	Good response, n (%)		36 (54.55)	34 (51.52)
	No response, n (%)	24	1 (1.56)	1 (1.56)	0.92***
	Moderate response, n (%)		18 (28.13)	20 (31.25)
	Good response, n (%)		45 (70.31)	43 (67.19)
EULAR response (ITT)	No response, n (%)	12	4 (5.88)	9 (13.24)	0.37***
	Moderate response, n (%)		28 (41.18)	25 (36.76)
	Good response, n (%)		36 (52.94)	34 (50.00)
	No response, n (%)	24	5 (7.35)	5 (7.35)	0.96***
	Moderate response, n (%)		18 (26.47)	20 (29.41)
	Good response, n (%)		45 (66.18)	43 (63.24)

DAS28-ESR disease activity score in 28 joints based on erythrocyte sedimentation rate, HAQ health assessment questionnaire, EULAR European League Against Rheumatism, PP per-protocol, ITT intention-to-treat. *Data are shown as mean ± SD and were analyzed using the independent samples t test. **Scores are shown as median (interquartile range) and were analyzed using the Mann-Whitney U test. ***Data were analyzed using Fisher's exact test

ISSN: 1478-6362