Skip to main content
. 2016 Dec;12(12):741–751.

Table 4.

Induction and Maintenance/Switch Studies of CT-P13 in IBD

Study Population Follow-Up Efficacy Safety
Park et al66

  • 95 CD (51 treatment-naive, 44 switched)

  • 78 UC (62 treatment-naive, 16 switched)

 Week 30 Clinical remission:

  • Moderate-to-severe CD: 59.0% treatment-naive; 80.6% switched

  • Fistulizing CD: 50% treatment-naive; 50% switched

  • UC: 37.0% treatment-naive; 45.5% switched

Mucosal healing:

  • 69% treatment-naive; 67% switched

 No unexpected adverse events (5 severe adverse events)
Kang et al54

  • 8 CD (3 treatment-naive, 5 switched)

  • 9 UC (5 treatment-naive, 4 switched)

 Week 8 (induction) Clinical remission:

  • CD: 2/3 treatment-naive; 4/5 switched

  • UC: 5/5 treatment-naive; 4/4 switched

 1 adverse event
Jung et al55

  • 59 CD (32 treatment-naive, 27 switched)

  • 51 UC (42 treatment-naive, 9 switched)

 Week 54 Clinical remission:

  • CD: 75% treatment-naive; 93% switched

  • UC: 50% treatment-naive; 67% switched

Mucosal healing:

  • UC: 67% treatment-naive

 5 adverse events in treatment-naive
Gecse et al67,68

  • 184 CD (25% non–treatment-naive)

  • 107 UC (14% non–treatment-naive)

 Week 54 Clinical remission:

  • CD: 47%

  • UC: 53%

Decreased remission rates when associated with prior anti-TNFα exposure Decreased CRP		 7.2% infusion reactions overall
Fiorino et al60

  • 223 CD (105 treatment-naive, 67 prior biologic agents, 51 switched)

  • 174 UC (112 treatment-naive, 20 prior biologic agents, 42 switched)

 6 months Clinical response (CD+UC):

  • 92% treatment-naive

  • 84% prior biologic agents

  • 94% switched

Loss of response in 12% of switched patients (5-fold greater than overall cohort)		 8.3% severe adverse events
5.3% infusion reactions
Guerra Veloz et al69,70

  • 75 CD (71 switched)

  • 40 UC (31 switched)

 6 months No difference between group in remission and group not in remission at start of study Mild adverse events: 6.6% in CD; 5.0% in UC
Carvalho Lourenço et al71

  • 19 CD (CT-P13)

  • 41 CD (IFX-R)

 Week 24 Significant decrease in HBI and CRP compared with baseline in both groups No infusion reactions with CT-P13
Hlavaty et al57

  • 19 CD

  • 6 UC

 Week 14 (induction); every 8 weeks for maintenance Clinical remission (CD+UC): 84% 4 adverse events overall
Hamanaka et al72

  • 8 CD

  • 12 UC

(14 treatment-naive) 		Week 22 Clinical remission:

  • CD: 100%

  • UC: 80%

 1 infusion reaction
Murphy et al73

  • 14 IBD (CT-P13)

  • 22 IBD (IFX-R)

 Not reported Higher surgery rate and hospital readmission rate, higher likelihood of corticosteroid augmentation, and no decrease in CRP with CT-P13 Not reported

CD, Crohn’s disease; CRP, C-reactive protein; CT-P13, infliximab biosimilar; HBI, Harvey-Bradshaw index; IBD, inflammatory bowel disease; IFX-R,originator infliximab–Remicade; TNFα, tumor necrosis factor-alpha; UC, ulcerative colitis.