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Table 3 Descriptive summary of ACR20 response rate at weeks 22 and 30 by dose received at week 14 (intention-to-treat population)

From: A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

 

No dose escalation (3 mg/kg) at week 14

Dose escalation (5 mg/kg) at week 14

 

PF-06438179/GP1111 (n = 240), n (%)

Infliximab-EU (n = 244), n (%)

Treatment difference, %

PF-06438179/GP1111 (n = 60), n (%)

Infliximab-EU (n = 68), n (%)

Treatment difference, %

Week 22

ACR20 response

 Yes

180 (75.0)

185 (75.8)

− 0.82

23 (38.3)

27 (39.7)

− 1.37

 No

58 (24.2)

58 (23.8)

 

36 (60.0)

36 (52.9)

 

 Missing

2 (0.8)

1 (0.4)

 

1 (1.7)

5 (7.4)

 

Week 30

ACR20 response

 Yes

169 (70.4)

181 (74.2)

− 3.76

27 (45.0)

27 (39.7)

5.29

 No

65 (27.1)

55 (22.5)

 

29 (48.3)

30 (44.1)

 

 Missing

6 (2.5)

8 (3.3)

 

4 (6.7)

11 (16.2)

 
  1. ACR20 American College of Rheumatology criteria for ≥ 20% clinical improvement, Infliximab-EU Infliximab sourced from the European Union