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

From: 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

Variable Week CinnoRA® Humira® P value
DAS28-ESR 12 2.95 ± 1.30 2.96 ± 1.41 0.97*
24 2.58 ± 1.06 2.55 ± 1.14 0.88*
HAQ 12 0.25 (0.88) 0.38 (0.88) 0.87**
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)
  1. 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