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Table 3 Intention-to-treat and per protocol analysis of patients according to the ACR30 response after 12 weeks of treatment and reaching the Wallace inactive disease criteria after treatment for 24 and 48 weeks on the basis of the initial patient allocation into groups

From: Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

Time-point

Efficacy parameter achieved

Intention-to-treat

Per protocol

Initial combination scheme ETA + MTX

Standard consequent scheme with MTXa

p

Initial combination scheme ETA + MTX

Standard consequent scheme with MTXa

p

12

ACR30

33/35 (94.3%)

20/33 (60.6%)

0.001

33/34 (97.1%)

20/32 (62.5%)

0.001

24

Wallace inactive disease

11/35 (31.4%)

11/33 (33.3%)

> 0.999

11/33 (33.3%)

11/30 (36.7%)

0.798

48

Wallace inactive disease

17/35 (48.6%)

20/33 (60.6%)

0.342

17/32 (53.1%)

19/29 (65.5%)

0.436

48

Remission

11/35 (31.4%)

8/33 (24.2%)

0.594

11/32 (34.4%)

8/29 (27.6%)

0.593

  1. aAccording to treatment regimen in this group, non-responders were supposed to switch to open-label ETA+MTX combination therapy after 12 or 24 weeks of treatment if they failed to reach the effectiveness parameter corresponding to the given week
  2. P values are based on Pearson’s χ2 test (for categorical data)