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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)