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Table 2 Improvement in patient-reported outcomes with CT-P13 and RP in the per-protocol population

From: A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study

 

CT-P13 (3 mg/kg)

RP (3 mg/kg)

Time point

n

Actual result (mean ± SD)

Change from baseline (mean ± SD)

n

Actual result (mean ± SD)

Change from baseline (mean ± SD)

VAS score for the patient assessment of pain

Baseline

248

65.7 ± 17.8

251

65.5 ± 17.7

Week 14

248

36.1 ± 21.4

−29.6 ± 23.3

250

38.3 ± 22.2

−27.1 ± 23.1

Week 30

248

36.2 ± 22.9

−29.5 ± 25.6

250

37.7 ± 23.6

−27.7 ± 24.9

Week 54

226

35.0 ± 21.2

−30.2 ± 23.8

220

37.4 ± 24.7

−28.4 ± 26.9

VAS score for the patient global assessment of disease activity

Baseline

248

65.1 ± 17.5

251

65.3 ± 17.3

Week 14

248

35.6 ± 21.1

−29.5 ± 22.1

249

39.7 ± 22.5

−25.5 ± 24.4

Week 30

247

37.0 ± 22.3

−28.1 ± 25.9

250

38.4 ± 23.4

−26.9 ± 25.5

Week 54

225

34.9 ± 20.7

−30.3 ± 24.3

220

38.7 ± 25.3

−26.6 ± 27.8

HAQ estimate of physical ability

Baseline

248

1.61 ± 0.56

251

1.54 ± 0.58

Week 14

248

1.02 ± 0.62

−0.59 ± 0.55

251

1.04 ± 0.64

−0.50 ± 0.50

Week 30

248

1.01 ± 0.64

−0.60 ± 0.60

251

1.03 ± 0.66

−0.51 ± 0.56

Week 54

226

0.99 ± 0.61

−0.60 ± 0.61

220

1.02 ± 0.64

−0.52 ± 0.59

SF-36 score (physical component summary)

Baseline

247

31.4 ± 6.1

251

31.8 ± 7.2

Week 14

247

38.9 ± 7.6

7.5 ± 7.1

251

37.6 ± 7.9

5.8 ± 6.8

Week 30

248

38.6 ± 7.9

7.1 ± 7.9

250

38.3 ± 8.0

6.5 ± 7.6

Week 54

226

39.2 ± 7.5

7.6 ± 8.1

220

38.6 ± 8.7

6.6 ± 8.4

SF-36 score (mental component summary)

Baseline

247

36.8 ± 10.4

251

38.4 ± 11.3

Week 14

247

43.4 ± 10.7

6.6 ± 10.2

251

44.9 ± 9.6

6.5 ± 10.4

Week 30

248

44.0 ± 10.2

7.1 ± 10.0

251

45.0 ± 10.3

6.6 ± 10.4

Week 54

226

43.9 ± 9.9

7.1 ± 10.1

220

45.1 ± 10.0

6.9 ± 11.2

  1. HAQ Health Assessment Questionnaire, RP reference product (i.e., reference infliximab), SD standard deviation, SF-36 Medical Outcomes Study Short Form Health Survey, VAS visual analogue scale (mm)