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. 2016 Dec;12(12):741–751.

Table 5.

Induction Studies of CT-P13 in IBD

Study Population Follow-Up Efficacy Safety
Jahnsen et al74

  • 46 CD (33 treatment–naive, 13 prior biologic agents [IFX-R, ADA, GOL])

  • 32 UC (27 treatment–naive, 5 prior biologic agents [IFX-R, ADA, GOL])

 Week 14 Clinical remission:

  • CD: 79%

  • UC: 56%

Significant reduction in CRP and calprotectin		 No unexpected adverse events
Keil et al75

  • 30 CD

  • 22 UC (all anti-TNFα treatment-naive)

 Week 14 Clinical remission:

  • CD: 50%

  • UC: 41%

Decreased CRP		 4 adverse events overall
Farkas et al76,77

  • 63 UC

  • 18 CD

 Week 14 (UC); Week 8 (CD) Clinical remission:

  • UC: 47.6%

  • CD: 50.0%

Mucosal healing:

  • UC: 47.6%

 New antidrug antibodies in 7 UC treatment–naive patients
Malickova et al78

  • 60 IBD (CT-P13; all anti-TNFα treatment-naive)

  • 71 IBD (IFX-R)

 Week 14 Not assessed No difference in antidrug antibodies or other autoantibodies
Sieczkowska et al79

  • 36 CD (17 treatment-naive) Pediatric

 Week 14

  • Clinical remission: 72%

  • Decrease in mean PCDAI

 1 allergic reaction
Muhammed et al80

  • 32 CD (18 CT-P13, 14 IFX-R)

  • 9 UC (6 CT-P13, 3 IFX-R) Pediatric

 Not specified No significant difference in clinical efficacy No significant difference in infusion reactions
Bortlik et al81

  • 79 CD

  • 25 UC

 Week 22 Complete or partial response:

  • CD: 89.6%

  • UC: 78.3%

Mucosal healing:

  • UC: 50.0%

 20 adverse events
New antidrug antibodies in 10% of patients
Kaniewska and Rydzewska82

  • 77 CD (IFX-R)

  • 52 CD (CT-P13)

  • 47 CD (ADA)

 12 months, then 6 months postcessation No difference in clinical response, CDAI, calprotectin, or relapse rate No difference in allergic reaction rates among IFX-R and CT-P13
Kaniewska and Rydzewska83

  • 32 UC (IFX-R)

  • 35 UC (CT-P13)

 Induction therapy (3 doses) and 6 months follow-up No significant difference in clinical response or endoscopic remission No difference in adverse events
Turk et al84

  • 25 UC

  • 19 CD

  • 2 unclassified

 8 months

  • Clinical and laboratory remission: 79%

  • Mucosal healing: 32% of patients in remission

 No severe adverse events

ADA, adalimumab; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; CT-P13, infliximab biosimilar; GOL, golimumab; IBD, inflammatory bowel disease; IFX-R, originator infliximab–Remicade; PCDAI, Pediatric Crohn’s Disease Activity Index; TNFα, tumor necrosis factor-alpha; UC, ulcerative colitis.