1. Phase III randomized controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn’s disease: 1-year maintenance and switching results
Y Kim, B Ye, M Pesegova, et al.
Slides compiled by Dr. Waqqas Afif
UEGW 2017

2. Introduction Background and objectives
In a Phase 3 RCT, biosimilar (CT-P13, Inflectra®) and reference infliximab (IFX, Remicade®) were found to have similar efficacy, safety and PK up to 30 weeks in moderate-to-severe CD1
Inflectra® was approved in Canada for moderate-to-severe CD in 2016
Objective: To investigate the efficacy and safety of CT-P13 following switching from IFX at 30 weeks in patients followed up to 54 weeks
CD: Crohn’s disease; IFX: reference infliximab; PK: pharmacokinetics; RCT: randomized controlled trial
1.Kim YH, et al. J Crohns Colitis 2017;11(Suppl 1):S62.

3. Primary efficacy endpoint
Method
Study design:
Primary endpoint
Efficacy: CDAI-70 at W6
Secondary endpoints
Efficacy: CDAI-70, Clinical remission, SIBDQ
Tertiary endpoints
Efficacy: CDAI-100, mucosal healing, calprotectin
Group 1 (n = 56) CT-P13 5 mg/kg
Group 2 (n = 55) CT-P13 5 mg/kg
IFX 5 mg/kg
Randomization (N = 220)
Group 3 (n = 54) IFX 5 mg/kg
Group 4 (n = 55) IFX 5 mg/kg
CT-P13 5 mg/kg
Infusion W0 W2 W6
W14
W22
W30
W W46
W54
Primary efficacy endpoint
Randomized switching
Randomization stratification factors: region (European vs non-European), disease duration (< 3 years vs ≥ 3 years), history of treatment with immunomodulator (AZA/6-MP/MTX; used vs not used)
6-MP, 6-mercaptopurine; AZA, azathioprine; CDAI, Crohn’s Disease Activity Index; MTX, methotrexate; SIBDQ, Short Inflammatory Bowel Disease Questionnaire

4. Efficacy – Clinical response and remission up to Week 54 (AR)
Clinical remission
Mucosal healing
(%)
(%)
CT-P13 – CT-P13
CT-P13 – IFX
IFX – IFX
IFX – CT-P13
CT-P13 – CT-P13
CT-P13 – IFX
IFX – IFX
IFX – CT-P13
p=0.8174
p =
Randomized switch
16/48
(33.3)
12/46
(28.1)
12/44
(27.3)
8/38
(21.1)
95% CI for mucosal healing in each treatment group are presented
AR: all-randomized population; IFX: reference infliximab

5. Efficacy – Calprotectin and CRP (AR)
Fecal calprotectin
CRP
Randomized switch
Randomized switch
Mean calprotectin (μg/g)
Mean CRP (mg/dL)
p =
p =
AR: all-randomized population; CRP: C-reactive protein; IFX: reference infliximab

6. Conclusions & significance to clinical practice
Biosimilar (CT-P13, Inflectra®) and reference infliximab (IFX, Remicade®) were found to have similar efficacy in moderate-to-severe CD up to 54 weeks
CT-P13 was well tolerated with a similar safety profile to that of IFX
Significance to clinical practice
In a short-term follow-up (24 weeks) there were no differences in clinical efficacy, biomarkers, or endoscopy findings post switch at 30 weeks (large non-inferiority margin of 20%)