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 1 Summary of the baseline characteristics of the patients

Variable	CinnoRA®	Humira®	P value
Age	48.29 ± 12.72	47.59 ± 11.48	0.73
Sex, n (%)
Male	10 (14.71%)	8 (11.76%)	0.85*
Female	58 (85.29%)	60 (88.24%)	0.85*
Swollen joint count, 28 joints	9.96 ± 7.39	9.46 ± 6.98	0.69
Tender joint count, 28 joints	9.46 ± 8.23	9.66 ± 7.97	0.88
Patient assessment of pain	67.21 ± 23.51	70.22 ± 21.93	0.44
Patient global assessment of disease activity	70.15 ± 20.35	70.74 ± 22.21	0.87
Physician’s global assessment of disease activity	68.97 ± 17.38	70.44 ± 17.68	0.63
CRP (mg/L)	21.40 ± 25.98	18.90 ± 23.90	0.57
ESR (mm/h)	32.65 ± 21.24	31.12 ± 24.01	0.69
HAQ	1.25 (1.38)	1.38 (1.13)	0.56^†
DAS28-ESR	5.51 ± 1.24	5.47 ± 1.28	0.87
RF	63.76 ± 57.22	76.95 ± 65.66	0.22

Data are shown as mean ± SD and were analyzed using the independent t test unless stated otherwise. CRP C-reactive protein, DAS28 disease activity score in 28 joints, ESR erythrocyte sedimentation rate, HAQ health assessment questionnaire, RF rheumatoid factor. *Data were analyzed using Pearson's chi-squared test. ^†Scores are shown as median (interquartile range) and were analyzed using the Mann-Whitney U test

ISSN: 1478-6362