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exposure) who received CT-P13 5  mg/kg at weeks 0, 2, and 6, except for three
severe UC patients who received either 10  mg/kg due to low albumin/high
C-reactive protein or an extra infusion 5–7 days later. Clinical efficacy was assessed
at week 14 including clinical activity scores, trough levels, and ADA positivity. At
week 14, 79% of CD patients and 56% of UC patients achieved clinical remission
with reductions in C-reactive protein and fecal calprotectin values compared to
baseline and no unexpected adverse events. Eight patients had undetectable trough
levels at week 14, and 7 of these 8 patients had detectable antibodies, but these
patients were only treated with CT-P13 monotherapy [ 19 ]. Another recently pub-
lished prospective, nationwide, observational cohort study from Hungary followed
210 IBD patients (126 CD and 84 UC) treated with CT-P13 induction at 5 mg/kg.
Reported outcomes included week 14 response and remission rates: CD 81% and
54%, UC 78% and 59% with infusion reactions occurring among 7% of patients,
and an adverse event rate of 17% [ 20 ].
However, there are no randomized controlled trial data currently available that
are equivalent to the PLANETAS or PLANETRA studies to confirm the clinical
efficacy, safety, and pharmacokinetic profiles of CT-P13 for the IBD patient popula-
tion. The influence of IBD-specific diseasestate-related factors on therapeutic effi-
cacy, safety, and pharmacokinetics when considering extrapolation of indications to
include IBD patients remains unexplored based on the currently available data. A
primary issue of concern pertains to the potential for immunogenicity with the bio-
similar product when used interchangeably with the reference product. There are
multiple factors influencing immunogenicity aside from just the biosimilar drug
itself, including medication dosing, schedule, disease type and severity for which
treatment is indicated, and the use of concomitant medications [ 21 ].
The two pivotal CT-P13 randomized controlled trials investigated biosimilar out-
comes as monotherapy dosed as 5  mg/kg for AS and combination therapy dosed as

Table 15.2 Efficacy and safety of CT-P13 in inflammatory bowel disease

Study

population Study design Sample size Outcome

CD and UC

[ 20 ]

Prospective, multicenter,

Hungarian nationwide,

observational cohort

210 (CD

126, UC 84)

Week 14 response: CD 81%, UC 78%

Week 14 remission: CD 54%, UC 59%

CD and UC

[ 19 ]

Prospective, observational

Norwegian cohort

78 (CD 46,

UC 32)

Week 14 remission: CD 79%, UC 56%

CD and UC

[ 71 ]

Single-center prospective

Hungarian observational

cohort

39 (CD 18,

UC 21)

Week 8 response: CD 38%, UC 20%

Week 8 remission: CD 50%, UC 10%

CD and UC

[ 72 ]

Retrospective, multicenter

Korean cohort study

74 anti-TNF

naïve (CD

32, UC 42)

Week 8 response: CD 91%, UC 81%

Week 8 remission: CD 84%, UC 38%

Week 54 response: CD 88%, UC 100%

Week 54 remission: CD 75%, UC 50%

CD and UC

[ 73 ]

Retrospective Korean

caseseries

17 (CD 8,

UC 9)

Week 8 response/remission: CD 25%,

UC 56%

15 Biosimilars in Inflammatory Bowel Disease 2017: State of the Science